<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03272737</url>
  </required_header>
  <id_info>
    <org_study_id>2016/07993-3</org_study_id>
    <nct_id>NCT03272737</nct_id>
  </id_info>
  <brief_title>Low Intensity Training Combined With KAATSU on Muscle Vasodilatation and Arterial Stiffness in the Elderly Population</brief_title>
  <official_title>Effect of Low Intensity Strength Training Combined With Moderate Blood Flow Restriction on Muscle Vasodilatation and Arterial Stiffness in Elders With Low Gait Velocity.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Israelita Albert Einstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Israelita Albert Einstein</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the present study is to evaluate the acute and chronic effect of low intensity&#xD;
      strength training with or without moderate blood flow restriction on muscle vasodilation and&#xD;
      arterial stiffness in elders with low gait speed. In addition, the responses of prothrombotic&#xD;
      factors in blood coagulation, the impact on heart rate and arterial pressure will be&#xD;
      assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose a study of 26 sedentary elders with low speed gait, supervised by&#xD;
      the Hospital Israelita Albert Einstein - Vila Mariana ambulatory. This will be an open&#xD;
      clinical trial, prospective, single center, randomized and controlled study. It will be&#xD;
      divided into two parts: acute and chronic phases. After signing an informed consent, the&#xD;
      participants will be separated in two groups:&#xD;
&#xD;
      Group 1. Resistance exercise with low intensity combined with partial blood flow restriction&#xD;
      Group 2. Conventional resistance exercise with low intensity&#xD;
&#xD;
      All of participants will be submitted to interventions tests before and after the period of&#xD;
      training which are:&#xD;
&#xD;
        1. Laboratory Tests: Blood tests&#xD;
&#xD;
        2. Plethysmography&#xD;
&#xD;
        3. Handgrip&#xD;
&#xD;
        4. Quality of life questionaire&#xD;
&#xD;
        5. FMD tests&#xD;
&#xD;
        6. Vasodilation capacity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2018</start_date>
  <completion_date type="Actual">January 4, 2022</completion_date>
  <primary_completion_date type="Actual">June 4, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Group 1: Blood flow restriction + low intensity strength exercise Group 2: Low intensity strength exercise</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anthropometric Assessment</measure>
    <time_frame>Before and after 12 weeksof training</time_frame>
    <description>The body weight will be evaluated using the Filizola brand scale, with an accuracy of 0.1 kg. The stature will be obtained by means of the stadiometer coupled to the Filizola scale, with an accuracy of 0.5 cm. The BMI will be calculated from the weight ratio by height squared. For measures of circumference of the quadriceps, a tape measure of the brand Seca, with precision of 0.1 cm will be used. Anthropometric measurements will be made following the standardization of the International Society for Anthropometric Assessments (ISAK, 2001).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Coagulation factors</measure>
    <time_frame>Before and after 12 weeksof training</time_frame>
    <description>Blood tests (fibrinogen, Factor VIII, von Willebrand Factor, D-dimer, t-PA and PAI 1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability, adherence and adverse effects</measure>
    <time_frame>Before and after 12 weeks of training</time_frame>
    <description>Evaluate the tolerability, adherence and adverse effects of both groups - Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial pressure and heart rate</measure>
    <time_frame>Before and after 12 weeks of training</time_frame>
    <description>Blood pressure and heart rate measurements</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Speed Gait</measure>
    <time_frame>Before and after 12 weeks of training</time_frame>
    <description>The gait velocity analysis will be performed with time marking, in thousandths of a second, from the displacement of the elderly in a 4.6-meter straight course, based on the measurement (speed / distance traveled).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Plesthysmography</measure>
    <time_frame>Before and after 12 weeks of training</time_frame>
    <description>Evaluation of muscle blood flow by plethysmography of venous occlusion</description>
  </other_outcome>
  <other_outcome>
    <measure>Pulse wave velocity</measure>
    <time_frame>Before and after 12 weeks of training</time_frame>
    <description>The estimation of the arterial stiffness will be made from the evaluation of the carotid-femoral aortic pulse wave velocity.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <arm_group>
    <arm_group_label>Traditional strength exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be carried out to knee extension exercise without blood flow restriction.&#xD;
Interventions:&#xD;
Plethysmography;&#xD;
Protocols of isometric exercise;&#xD;
Pulse wave Velocity (PWV);&#xD;
Flow-mediated dilatation (FMD);&#xD;
Arterial pressure and blood pressure;&#xD;
Quality of life (Euro Qol);&#xD;
1RM test&#xD;
Speed gait test&#xD;
Anthropometric Assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be carried out to knee extension exercise with partial blood flow restriction.&#xD;
Interventions:&#xD;
Plethysmography;&#xD;
Protocols of isometric exercise;&#xD;
Pulse wave Velocity (PWV);&#xD;
Flow-mediated dilatation (FMD);&#xD;
Arterial pressure and blood pressure;&#xD;
Quality of life (Euro Qol);&#xD;
1RM test&#xD;
Speed gait test&#xD;
Anthropometric Assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>1RM Test</intervention_name>
    <description>The dynamic force of the lower limb muscles will be evaluated by the maximal repetition of knee extension and leg press exercise, according to the protocol presented in a previous study [37]. The elderly will perform a warm up consisting of 1 series with 10 unloaded repetitions. After the warm up, the mass to be lifted will be progressively increased until the maximum load that can be lifted is reached, with a maximum limit of 5 attempts and a 3 to 5 minutes interval between them. The test will be conducted by a physical education professional who will verbally encourage participants throughout these steps and perform the load adjustment at week 5 and 10 (Radaelli, 2014).</description>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_label>Traditional strength exercise</arm_group_label>
    <other_name>1RM Test (Knee extension and Seated leg press)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Speed gait test</intervention_name>
    <description>To measure the gait speed of participants they will walk 4.6 metres and the time needed to cover this distance is measured. The mean of three attempts is recorded and divided by the distance. The participants included must achieve in the walking test an average of &lt; 0.,9 m/s (Guralnik, 1994).</description>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_label>Traditional strength exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Venous occlusion plethysmography protocol</intervention_name>
    <description>A mercury-filled silastic tube, connected to a low-pressure transducer and a plethysmograph (D.E. Hokanson), will be placed around the largest circumference of the calf region. One cuff will be placed around the ankle and another around the thigh. The ankle cuff will be inflated to a supra-systolic pressure 30 seconds before starting the measurements. At 15-second intervals, the cuff around the thigh will be inflated above the venous pressure for a period of seven to eight seconds. Increased tension in the silastic tube reflects an increase in leg volume and vasodilation. The signal of the muscle blood flow wave will be recorded on a polygraph and analysed every minute, averaging three records per minute. The protocol will be performed during 5 minutes of rest, 3 minutes isometric exercise and 2 minutes of recovery (Bahia, 2006).</description>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_label>Traditional strength exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity</intervention_name>
    <description>Arterial stiffness will be estimated from the carotid-femoral aortic pulse wave velocity [33]. Carotid-femoral aortic pulse waves will be recorded by tonometry (SphygmoCor, AtCor Medical, Australia). At the same time, an electrocardiogram will be obtained to calculate the wave transit time. Two distances will be measured: the recording point of the carotid artery and the sternal furcula (distance 1) and the sternal furcula and the recording point in the femoral artery (distance 2). The distance travelled by the pulse wave will be calculated as &quot;distance 2&quot; - &quot;distance 1&quot;. The carotid-femoral aortic pulse wave velocity will be calculated as: carotid-femoral aortic pulse wave velocity = ¼ * distance travelled by the pulse wave (m) / transit time(s).</description>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_label>Traditional strength exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Isometric handgrip exercise protocol</intervention_name>
    <description>In a supine position, the maximal voluntary handgrip force will be determined as the highest force in 3 consecutive attempts using a Jamar hydraulic palmar dynamometer (Asimow Engineering, CAL, USA). For activation of the central command, mechanoreceptors and muscular metaboreceptors the individual will perform, after 5 minutes of rest (baseline records), 3 minutes of exercise at 30% MVC. This manoeuvre isolates the activation of muscle metaboreceptors, observing the selective activation of these. After the isometric handgrip exercise, 2 minutes of recovery will be performed. Throughout the protocol muscle blood flow, blood pressure and heart rate will be recorded.</description>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_label>Traditional strength exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vasodilatory capacity</intervention_name>
    <description>The vasodilatory capacity will be calculated as the percentage of increase of the diameter of the brachial artery and femoral post occlusion in relation to its basal values.</description>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_label>Traditional strength exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)</intervention_name>
    <description>Images of the brachial artery will be recorded by a two-dimensional ultrasonography device with a spectral Doppler and linear transducer (Ultra-0122, Philips, The Netherlands).</description>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_label>Traditional strength exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quality of Life EuroQol-5 Domain</intervention_name>
    <description>This questionnaire is used to estimate the quality of life in participants before and after the study.</description>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_label>Traditional strength exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anthropometric Assessment</intervention_name>
    <description>Anthropometric measurements will be made before and after the training program following the standardization of the International Society for Anthropometric Assessments. The body mass will be measured with an accuracy of 0.1 kg (Filizola). The stature will be obtained by means of the stadiometer with an accuracy of 0.5 cm. The BMI will be calculated as body mass divided by height squared. The circumference of the quadriceps will be measured with a tape measure (Seca) with a precision of 0.1 cm.</description>
    <arm_group_label>Strength exercise with KAATSU</arm_group_label>
    <arm_group_label>Traditional strength exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elderly people aged 60 to 85 years, with walking speed &lt;0.8m / s (Guralnik, 1994).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Elderly patients with uncontrolled diabetes mellitus or peripheral neuropathy;&#xD;
&#xD;
          -  Symptomatic peripheral obstructive arterial disease or brachial ankle index &lt;0.9;&#xD;
&#xD;
          -  Uncontrolled arterial hypertension (BP&gt; 160 / 100mmHg);&#xD;
&#xD;
          -  Uncontrolled dyslipidemia (total colostrum&gt; 220mg / dL);&#xD;
&#xD;
          -  Infectious with less than 1 month;&#xD;
&#xD;
          -  Osteoarticular or neurological problems that prevent training;&#xD;
&#xD;
          -  History of anemia, cerebrovascular disease, myocardial infarction in the last 6&#xD;
             months;&#xD;
&#xD;
          -  Pior deep venous thrombosis;&#xD;
&#xD;
          -  Use of oral anticoagulant;&#xD;
&#xD;
          -  Smoking &lt;6 months;&#xD;
&#xD;
          -  Use of antiplatelet agents and anticoagulants;&#xD;
&#xD;
          -  Cognitive dysfunctions: Mini-mental &lt;24. (Brucki, 2003).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luciana D Janot, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>05652-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Willoughby, D.S. American College of Sports Medicine. ACSM current comment: Resistance Training and the Older Adult. 2012.</citation>
  </reference>
  <results_reference>
    <citation>Amano S, Ludin AF, Clift R, Nakazawa M, Law TD, Rush LJ, Manini TM, Thomas JS, Russ DW, Clark BC. Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 12;17:81. doi: 10.1186/s13063-016-1214-7.</citation>
    <PMID>26867541</PMID>
  </results_reference>
  <results_reference>
    <citation>Bahia L, de Aguiar LG, Villela NR, Bottino D, Bouskela E. [The endothelium in the metabolic syndrome]. Arq Bras Endocrinol Metabol. 2006 Apr;50(2):291-303. doi: 10.1590/s0004-27302006000200015. Epub 2006 May 23. Erratum In: Arq Bras Endocrinol Metabol. 2006 Jun;50(3):574. Portuguese.</citation>
    <PMID>16767295</PMID>
  </results_reference>
  <results_reference>
    <citation>Brucki SM, Nitrini R, Caramelli P, Bertolucci PH, Okamoto IH. [Suggestions for utilization of the mini-mental state examination in Brazil]. Arq Neuropsiquiatr. 2003 Sep;61(3B):777-81. doi: 10.1590/s0004-282x2003000500014. Epub 2003 Oct 28. Portuguese.</citation>
    <PMID>14595482</PMID>
  </results_reference>
  <results_reference>
    <citation>Cadore EL, Rodriguez-Manas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397.</citation>
    <PMID>23327448</PMID>
  </results_reference>
  <results_reference>
    <citation>Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011 Apr 5;57(14):1511-22. doi: 10.1016/j.jacc.2010.12.017.</citation>
    <PMID>21453829</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen X, Mao G, Leng SX. Frailty syndrome: an overview. Clin Interv Aging. 2014 Mar 19;9:433-41. doi: 10.2147/CIA.S45300. eCollection 2014.</citation>
    <PMID>24672230</PMID>
  </results_reference>
  <results_reference>
    <citation>Crenshaw AG, Hargens AR, Gershuni DH, Rydevik B. Wide tourniquet cuffs more effective at lower inflation pressures. Acta Orthop Scand. 1988 Aug;59(4):447-51. doi: 10.3109/17453678809149401.</citation>
    <PMID>3421083</PMID>
  </results_reference>
  <results_reference>
    <citation>D'Antona G, Pellegrino MA, Adami R, Rossi R, Carlizzi CN, Canepari M, Saltin B, Bottinelli R. The effect of ageing and immobilization on structure and function of human skeletal muscle fibres. J Physiol. 2003 Oct 15;552(Pt 2):499-511. doi: 10.1113/jphysiol.2003.046276.</citation>
    <PMID>14561832</PMID>
  </results_reference>
  <results_reference>
    <citation>Dobrosielski DA, Greenway FL, Welsh DA, Jazwinski SM, Welsch MA; Louisiana Healthy Aging Study. Modification of vascular function after handgrip exercise training in 73- to 90-yr-old men. Med Sci Sports Exerc. 2009 Jul;41(7):1429-35. doi: 10.1249/MSS.0b013e318199bef4.</citation>
    <PMID>19516158</PMID>
  </results_reference>
  <results_reference>
    <citation>Esmon CT. Basic mechanisms and pathogenesis of venous thrombosis. Blood Rev. 2009 Sep;23(5):225-9. doi: 10.1016/j.blre.2009.07.002.</citation>
    <PMID>19683659</PMID>
  </results_reference>
  <results_reference>
    <citation>Fahs CA, Rossow LM, Thiebaud RS, Loenneke JP, Kim D, Abe T, Beck TW, Feeback DL, Bemben DA, Bemben MG. Vascular adaptations to low-load resistance training with and without blood flow restriction. Eur J Appl Physiol. 2014 Apr;114(4):715-24. doi: 10.1007/s00421-013-2808-3. Epub 2013 Dec 31.</citation>
    <PMID>24375201</PMID>
  </results_reference>
  <results_reference>
    <citation>Fielding RA, Rejeski WJ, Blair S, Church T, Espeland MA, Gill TM, Guralnik JM, Hsu FC, Katula J, King AC, Kritchevsky SB, McDermott MM, Miller ME, Nayfield S, Newman AB, Williamson JD, Bonds D, Romashkan S, Hadley E, Pahor M; LIFE Research Group. The Lifestyle Interventions and Independence for Elders Study: design and methods. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1226-37. doi: 10.1093/gerona/glr123. Epub 2011 Aug 8.</citation>
    <PMID>21825283</PMID>
  </results_reference>
  <results_reference>
    <citation>Fried LP, Carlson MC, Freedman M, Frick KD, Glass TA, Hill J, McGill S, Rebok GW, Seeman T, Tielsch J, Wasik BA, Zeger S. A social model for health promotion for an aging population: initial evidence on the Experience Corps model. J Urban Health. 2004 Mar;81(1):64-78. doi: 10.1093/jurban/jth094.</citation>
    <PMID>15047786</PMID>
  </results_reference>
  <results_reference>
    <citation>Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.</citation>
    <PMID>20150565</PMID>
  </results_reference>
  <results_reference>
    <citation>Frontera WR, Suh D, Krivickas LS, Hughes VA, Goldstein R, Roubenoff R. Skeletal muscle fiber quality in older men and women. Am J Physiol Cell Physiol. 2000 Sep;279(3):C611-8. doi: 10.1152/ajpcell.2000.279.3.C611.</citation>
    <PMID>10942711</PMID>
  </results_reference>
  <results_reference>
    <citation>Fujimoto N, Prasad A, Hastings JL, Arbab-Zadeh A, Bhella PS, Shibata S, Palmer D, Levine BD. Cardiovascular effects of 1 year of progressive and vigorous exercise training in previously sedentary individuals older than 65 years of age. Circulation. 2010 Nov 2;122(18):1797-805. doi: 10.1161/CIRCULATIONAHA.110.973784. Epub 2010 Oct 18.</citation>
    <PMID>20956204</PMID>
  </results_reference>
  <results_reference>
    <citation>Gates PE, Tanaka H, Graves J, Seals DR. Left ventricular structure and diastolic function with human ageing. Relation to habitual exercise and arterial stiffness. Eur Heart J. 2003 Dec;24(24):2213-20. doi: 10.1016/j.ehj.2003.09.026.</citation>
    <PMID>14659773</PMID>
  </results_reference>
  <results_reference>
    <citation>Golbidi S, Laher I. Exercise and the aging endothelium. J Diabetes Res. 2013;2013:789607. doi: 10.1155/2013/789607. Epub 2013 Aug 1.</citation>
    <PMID>23984434</PMID>
  </results_reference>
  <results_reference>
    <citation>Graham B, Breault MJ, McEwen JA, McGraw RW. Occlusion of arterial flow in the extremities at subsystolic pressures through the use of wide tourniquet cuffs. Clin Orthop Relat Res. 1993 Jan;(286):257-61.</citation>
    <PMID>8425355</PMID>
  </results_reference>
  <results_reference>
    <citation>Harris RA, Nishiyama SK, Wray DW, Richardson RS. Ultrasound assessment of flow-mediated dilation. Hypertension. 2010 May;55(5):1075-85. doi: 10.1161/HYPERTENSIONAHA.110.150821. Epub 2010 Mar 29.</citation>
    <PMID>20351340</PMID>
  </results_reference>
  <results_reference>
    <citation>Horiuchi M, Okita K. Blood flow restricted exercise and vascular function. Int J Vasc Med. 2012;2012:543218. doi: 10.1155/2012/543218. Epub 2012 Oct 22.</citation>
    <PMID>23133756</PMID>
  </results_reference>
  <results_reference>
    <citation>Karabulut M, Sherk VD, Bemben DA, Bemben MG. Inflammation marker, damage marker and anabolic hormone responses to resistance training with vascular restriction in older males. Clin Physiol Funct Imaging. 2013 Sep;33(5):393-9. doi: 10.1111/cpf.12044. Epub 2013 Apr 23.</citation>
    <PMID>23701309</PMID>
  </results_reference>
  <results_reference>
    <citation>Kovacic JC, Moreno P, Nabel EG, Hachinski V, Fuster V. Cellular senescence, vascular disease, and aging: part 2 of a 2-part review: clinical vascular disease in the elderly. Circulation. 2011 May 3;123(17):1900-10. doi: 10.1161/CIRCULATIONAHA.110.009118. No abstract available.</citation>
    <PMID>21537006</PMID>
  </results_reference>
  <results_reference>
    <citation>Zembron-Lacny A, Dziubek W, Rogowski L, Skorupka E, Dabrowska G. Sarcopenia: monitoring, molecular mechanisms, and physical intervention. Physiol Res. 2014;63(6):683-91. doi: 10.33549/physiolres.932692. Epub 2014 Aug 26.</citation>
    <PMID>25157651</PMID>
  </results_reference>
  <results_reference>
    <citation>Lexell J. Human aging, muscle mass, and fiber type composition. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:11-6. doi: 10.1093/gerona/50a.special_issue.11.</citation>
    <PMID>7493202</PMID>
  </results_reference>
  <results_reference>
    <citation>Libardi CA, Chacon-Mikahil MP, Cavaglieri CR, Tricoli V, Roschel H, Vechin FC, Conceicao MS, Ugrinowitsch C. Effect of concurrent training with blood flow restriction in the elderly. Int J Sports Med. 2015 May;36(5):395-9. doi: 10.1055/s-0034-1390496. Epub 2015 Feb 20.</citation>
    <PMID>25700103</PMID>
  </results_reference>
  <results_reference>
    <citation>Loenneke JP, Fahs CA, Rossow LM, Thiebaud RS, Mattocks KT, Abe T, Bemben MG. Blood flow restriction pressure recommendations: a tale of two cuffs. Front Physiol. 2013 Sep 10;4:249. doi: 10.3389/fphys.2013.00249. eCollection 2013. No abstract available.</citation>
    <PMID>24058346</PMID>
  </results_reference>
  <results_reference>
    <citation>Manini TM, Yarrow JF, Buford TW, Clark BC, Conover CF, Borst SE. Growth hormone responses to acute resistance exercise with vascular restriction in young and old men. Growth Horm IGF Res. 2012 Oct;22(5):167-72. doi: 10.1016/j.ghir.2012.05.002. Epub 2012 Jun 23.</citation>
    <PMID>22727808</PMID>
  </results_reference>
  <results_reference>
    <citation>Manini TM, Visser M, Won-Park S, Patel KV, Strotmeyer ES, Chen H, Goodpaster B, De Rekeneire N, Newman AB, Simonsick EM, Kritchevsky SB, Ryder K, Schwartz AV, Harris TB. Knee extension strength cutpoints for maintaining mobility. J Am Geriatr Soc. 2007 Mar;55(3):451-7. doi: 10.1111/j.1532-5415.2007.01087.x.</citation>
    <PMID>17341251</PMID>
  </results_reference>
  <results_reference>
    <citation>Mattar MA, Gualano B, Perandini LA, Shinjo SK, Lima FR, Sa-Pinto AL, Roschel H. Safety and possible effects of low-intensity resistance training associated with partial blood flow restriction in polymyositis and dermatomyositis. Arthritis Res Ther. 2014 Oct 25;16(5):473. doi: 10.1186/s13075-014-0473-5.</citation>
    <PMID>25344395</PMID>
  </results_reference>
  <results_reference>
    <citation>Miljkovic N, Lim JY, Miljkovic I, Frontera WR. Aging of skeletal muscle fibers. Ann Rehabil Med. 2015 Apr;39(2):155-62. doi: 10.5535/arm.2015.39.2.155. Epub 2015 Apr 24.</citation>
    <PMID>25932410</PMID>
  </results_reference>
  <results_reference>
    <citation>de Souza ER, Correia BS. [Construction of indicators for assessing the policy of reducing accidents and violence for the elderly care]. Cien Saude Colet. 2010 Sep;15(6):2753-62. doi: 10.1590/s1413-81232010000600013. Portuguese.</citation>
    <PMID>20922284</PMID>
  </results_reference>
  <results_reference>
    <citation>Moore A, Mangoni AA, Lyons D, Jackson SH. The cardiovascular system. Br J Clin Pharmacol. 2003 Sep;56(3):254-60. doi: 10.1046/j.0306-5251.2003.01876.x.</citation>
    <PMID>12919173</PMID>
  </results_reference>
  <results_reference>
    <citation>Nakajima, T. et al. Effects of Exercise and Anti-Aging. Anti-Aging Medicine. 2011. v. 7 n. 8. p. 92-102.</citation>
  </results_reference>
  <results_reference>
    <citation>Nakajima, T. et al. Effects of low intensity Kaatsu resistance training on skeletal muscle size/strength and endurance capacity in patients with ischemic heart diseases. International Journal of Kaatsu Training Research. 2010. v. 6. p. 1-7.</citation>
  </results_reference>
  <results_reference>
    <citation>Nakajima, T. et al. Use and safety of KAATSU training; Results of a national survey. International Journal of Kaatsu Training Research. 2006. v. 2. p. 5-13</citation>
  </results_reference>
  <results_reference>
    <citation>Nazari-Shafti TZ, Cooke JP. Telomerase Therapy to Reverse Cardiovascular Senescence. Methodist Debakey Cardiovasc J. 2015 Jul-Sep;11(3):172-5. doi: 10.14797/mdcj-11-3-172.</citation>
    <PMID>26634025</PMID>
  </results_reference>
  <results_reference>
    <citation>Norton K.; Olds T. International Standards for Anthropometric Assessment. 1a ed. Austrália: The International Society for the Advancement of Kinanthropometry; 1996.</citation>
  </results_reference>
  <results_reference>
    <citation>Odden MC, Peralta CA, Haan MN, Covinsky KE. Rethinking the association of high blood pressure with mortality in elderly adults: the impact of frailty. Arch Intern Med. 2012 Aug 13;172(15):1162-8. doi: 10.1001/archinternmed.2012.2555.</citation>
    <PMID>22801930</PMID>
  </results_reference>
  <results_reference>
    <citation>Ozaki H, Loenneke JP, Thiebaud RS, Stager JM, Abe T. Possibility of leg muscle hypertrophy by ambulation in older adults: a brief review. Clin Interv Aging. 2013;8:369-75. doi: 10.2147/CIA.S43837. Epub 2013 Mar 31.</citation>
    <PMID>23573066</PMID>
  </results_reference>
  <results_reference>
    <citation>Park DC, Yeo SG. Aging. Korean J Audiol. 2013 Sep;17(2):39-44. doi: 10.7874/kja.2013.17.2.39. Epub 2013 Sep 24.</citation>
    <PMID>24653904</PMID>
  </results_reference>
  <results_reference>
    <citation>Park SY, Kwak YS, Harveson A, Weavil JC, Seo KE. Low intensity resistance exercise training with blood flow restriction: insight into cardiovascular function, and skeletal muscle hypertrophy in humans. Korean J Physiol Pharmacol. 2015 May;19(3):191-6. doi: 10.4196/kjpp.2015.19.3.191. Epub 2015 Apr 30.</citation>
    <PMID>25954122</PMID>
  </results_reference>
  <results_reference>
    <citation>Radaelli R, Botton CE, Wilhelm EN, Bottaro M, Brown LE, Lacerda F, Gaya A, Moraes K, Peruzzolo A, Pinto RS. Time course of low- and high-volume strength training on neuromuscular adaptations and muscle quality in older women. Age (Dordr). 2014 Apr;36(2):881-92. doi: 10.1007/s11357-013-9611-2. Epub 2014 Jan 11.</citation>
    <PMID>24414336</PMID>
  </results_reference>
  <results_reference>
    <citation>Martinez-Ramirez A, Martinikorena I, Gomez M, Lecumberri P, Millor N, Rodriguez-Manas L, Garcia Garcia FJ, Izquierdo M. Frailty assessment based on trunk kinematic parameters during walking. J Neuroeng Rehabil. 2015 May 24;12:48. doi: 10.1186/s12984-015-0040-6.</citation>
    <PMID>26003560</PMID>
  </results_reference>
  <results_reference>
    <citation>Ray CA, Rea RF, Clary MP, Mark AL. Muscle sympathetic nerve responses to dynamic one-legged exercise: effect of body posture. Am J Physiol. 1993 Jan;264(1 Pt 2):H1-7. doi: 10.1152/ajpheart.1993.264.1.H1.</citation>
    <PMID>8430836</PMID>
  </results_reference>
  <results_reference>
    <citation>Ribeiro, F.A et al. Síndrome metabólica: complacência arterial e a velocidade de onda de pulso. Revista da AMRIGS. 2012. v. 56. n. 1. p. 75-80.</citation>
  </results_reference>
  <results_reference>
    <citation>Ricci NA, Pessoa GS, Ferriolli E, Dias RC, Perracini MR. Frailty and cardiovascular risk in community-dwelling elderly: a population-based study. Clin Interv Aging. 2014 Oct 6;9:1677-85. doi: 10.2147/CIA.S68642. eCollection 2014.</citation>
    <PMID>25336932</PMID>
  </results_reference>
  <results_reference>
    <citation>Russ DW, Grandy JS, Toma K, Ward CW. Ageing, but not yet senescent, rats exhibit reduced muscle quality and sarcoplasmic reticulum function. Acta Physiol (Oxf). 2011 Mar;201(3):391-403. doi: 10.1111/j.1748-1716.2010.02191.x. Epub 2010 Nov 9.</citation>
    <PMID>20874807</PMID>
  </results_reference>
  <results_reference>
    <citation>Satoh, I. Kaatsu Training: Application to Metabolic Syndrome. 2011. International Journal of Kaatsu Training Research. 2011. v. 7. p. 7-12.</citation>
  </results_reference>
  <results_reference>
    <citation>Raskob GE, Angchaisuksiri P, Blanco AN, Buller H, Gallus A, Hunt BJ, Hylek EM, Kakkar A, Konstantinides SV, McCumber M, Ozaki Y, Wendelboe A, Weitz JI; ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to global disease burden. Arterioscler Thromb Vasc Biol. 2014 Nov;34(11):2363-71. doi: 10.1161/ATVBAHA.114.304488.</citation>
    <PMID>25304324</PMID>
  </results_reference>
  <results_reference>
    <citation>Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Blood flow restricted exercise for athletes: A review of available evidence. J Sci Med Sport. 2016 May;19(5):360-7. doi: 10.1016/j.jsams.2015.04.014. Epub 2015 May 9.</citation>
    <PMID>26118847</PMID>
  </results_reference>
  <results_reference>
    <citation>Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26.</citation>
    <PMID>24864078</PMID>
  </results_reference>
  <results_reference>
    <citation>Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.</citation>
    <PMID>10846023</PMID>
  </results_reference>
  <results_reference>
    <citation>Thijssen DH, Black MA, Pyke KE, Padilla J, Atkinson G, Harris RA, Parker B, Widlansky ME, Tschakovsky ME, Green DJ. Assessment of flow-mediated dilation in humans: a methodological and physiological guideline. Am J Physiol Heart Circ Physiol. 2011 Jan;300(1):H2-12. doi: 10.1152/ajpheart.00471.2010. Epub 2010 Oct 15.</citation>
    <PMID>20952670</PMID>
  </results_reference>
  <results_reference>
    <citation>Verdijk LB, Koopman R, Schaart G, Meijer K, Savelberg HH, van Loon LJ. Satellite cell content is specifically reduced in type II skeletal muscle fibers in the elderly. Am J Physiol Endocrinol Metab. 2007 Jan;292(1):E151-7. doi: 10.1152/ajpendo.00278.2006. Epub 2006 Aug 22.</citation>
    <PMID>16926381</PMID>
  </results_reference>
  <results_reference>
    <citation>Villacorta H, Bortolotto LA, Arteaga E, Mady C. Aortic distensibility measured by pulse-wave velocity is not modified in patients with Chagas' disease. J Negat Results Biomed. 2006 Jun 12;5:9. doi: 10.1186/1477-5751-5-9.</citation>
    <PMID>16768804</PMID>
  </results_reference>
  <results_reference>
    <citation>Wernbom, M. Effects of an acute bout of low-load resistance training with blood flow restriction. 2011. 206 f. Dissertation. The Norwegian School of Sports Sciences. Noruega. 2011.</citation>
  </results_reference>
  <results_reference>
    <citation>World Health Organization. Global brief for World Health Day. 2012. http://www.who.int/world_health_day/2012.</citation>
  </results_reference>
  <results_reference>
    <citation>Wu IC, Lin CC, Hsiung CA. Emerging roles of frailty and inflammaging in risk assessment of age-related chronic diseases in older adults: the intersection between aging biology and personalized medicine. Biomedicine (Taipei). 2015;5(1):1. doi: 10.7603/s40681-015-0001-1. Epub 2015 Feb 2.</citation>
    <PMID>25722960</PMID>
  </results_reference>
  <results_reference>
    <citation>Yasuda T, Loenneke JP, Thiebaud RS, Abe T. Effects of blood flow restricted low-intensity concentric or eccentric training on muscle size and strength. PLoS One. 2012;7(12):e52843. doi: 10.1371/journal.pone.0052843. Epub 2012 Dec 31.</citation>
    <PMID>23300795</PMID>
  </results_reference>
  <results_reference>
    <citation>Yasuda T, Fukumura K, Iida H, Nakajima T. Effects of detraining after blood flow-restricted low-load elastic band training on muscle size and arterial stiffness in older women. Springerplus. 2015 Jul 15;4:348. doi: 10.1186/s40064-015-1132-2. eCollection 2015.</citation>
    <PMID>26191475</PMID>
  </results_reference>
  <results_reference>
    <citation>Yasuda T, Fukumura K, Uchida Y, Koshi H, Iida H, Masamune K, Yamasoba T, Sato Y, Nakajima T. Effects of Low-Load, Elastic Band Resistance Training Combined With Blood Flow Restriction on Muscle Size and Arterial Stiffness in Older Adults. J Gerontol A Biol Sci Med Sci. 2015 Aug;70(8):950-8. doi: 10.1093/gerona/glu084. Epub 2014 Jun 10.</citation>
    <PMID>24917178</PMID>
  </results_reference>
  <results_reference>
    <citation>Yokokawa Y, Hongo M, Urayama H, Nishimura T, Kai I. Effects of low-intensity resistance exercise with vascular occlusion on physical function in healthy elderly people. Biosci Trends. 2008 Jun;2(3):117-23.</citation>
    <PMID>20103914</PMID>
  </results_reference>
  <results_reference>
    <citation>Nakajima, T.; Morita, T.; Sato, Y. Key considerations when conducting KAATSU training. International Journal of Kaatsu Training Research. 2011. v. 7. p. 1-6.</citation>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 10, 2022</last_update_submitted>
  <last_update_submitted_qc>February 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>KAATSU</keyword>
  <keyword>Cardiovascular system</keyword>
  <keyword>Elderly</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 23, 2022</submitted>
    <returned>July 19, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03272737
org study id: 2016/07993-3
nct id: NCT03272737
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of the present study is to evaluate the acute and chronic effect of low intensity
      strength training with or without moderate blood flow restriction on muscle vasodilation and
      arterial stiffness in elders with low gait speed. In addition, the responses of prothrombotic
      factors in blood coagulation, the impact on heart rate and arterial pressure will be
      assessed.
The investigators propose a study of 26 sedentary elders with low speed gait, supervised by
      the Hospital Israelita Albert Einstein - Vila Mariana ambulatory. This will be an open
      clinical trial, prospective, single center, randomized and controlled study. It will be
      divided into two parts: acute and chronic phases. After signing an informed consent, the
      participants will be separated in two groups:

      Group 1. Resistance exercise with low intensity combined with partial blood flow restriction
      Group 2. Conventional resistance exercise with low intensity

      All of participants will be submitted to interventions tests before and after the period of
      training which are:

        1. Laboratory Tests: Blood tests

        2. Plethysmography

        3. Handgrip

        4. Quality of life questionaire

        5. FMD tests

        6. Vasodilation capacity
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group 1: Blood flow restriction + low intensity strength exercise Group 2: Low intensity strength exercise
primary purpose: Treatment
masking: Single (Participant)
measure: Anthropometric Assessment
time frame: Before and after 12 weeksof training
description: The body weight will be evaluated using the Filizola brand scale, with an accuracy of 0.1 kg. The stature will be obtained by means of the stadiometer coupled to the Filizola scale, with an accuracy of 0.5 cm. The BMI will be calculated from the weight ratio by height squared. For measures of circumference of the quadriceps, a tape measure of the brand Seca, with precision of 0.1 cm will be used. Anthropometric measurements will be made following the standardization of the International Society for Anthropometric Assessments (ISAK, 2001).
measure: Coagulation factors
time frame: Before and after 12 weeksof training
description: Blood tests (fibrinogen, Factor VIII, von Willebrand Factor, D-dimer, t-PA and PAI 1)
measure: Tolerability, adherence and adverse effects
time frame: Before and after 12 weeks of training
description: Evaluate the tolerability, adherence and adverse effects of both groups - Questionnaire
measure: Arterial pressure and heart rate
time frame: Before and after 12 weeks of training
description: Blood pressure and heart rate measurements
measure: Speed Gait
time frame: Before and after 12 weeks of training
description: The gait velocity analysis will be performed with time marking, in thousandths of a second, from the displacement of the elderly in a 4.6-meter straight course, based on the measurement (speed / distance traveled).
measure: Plesthysmography
time frame: Before and after 12 weeks of training
description: Evaluation of muscle blood flow by plethysmography of venous occlusion
measure: Pulse wave velocity
time frame: Before and after 12 weeks of training
description: The estimation of the arterial stiffness will be made from the evaluation of the carotid-femoral aortic pulse wave velocity.
arm group label: Traditional strength exercise
arm group type: Active Comparator
description: This group will be carried out to knee extension exercise without blood flow restriction.
Interventions:
Plethysmography;
Protocols of isometric exercise;
Pulse wave Velocity (PWV);
Flow-mediated dilatation (FMD);
Arterial pressure and blood pressure;
Quality of life (Euro Qol);
1RM test
Speed gait test
Anthropometric Assessment
arm group label: Strength exercise with KAATSU
arm group type: Active Comparator
description: This group will be carried out to knee extension exercise with partial blood flow restriction.
Interventions:
Plethysmography;
Protocols of isometric exercise;
Pulse wave Velocity (PWV);
Flow-mediated dilatation (FMD);
Arterial pressure and blood pressure;
Quality of life (Euro Qol);
1RM test
Speed gait test
Anthropometric Assessment
intervention type: Procedure
intervention name: 1RM Test
description: The dynamic force of the lower limb muscles will be evaluated by the maximal repetition of knee extension and leg press exercise, according to the protocol presented in a previous study [37]. The elderly will perform a warm up consisting of 1 series with 10 unloaded repetitions. After the warm up, the mass to be lifted will be progressively increased until the maximum load that can be lifted is reached, with a maximum limit of 5 attempts and a 3 to 5 minutes interval between them. The test will be conducted by a physical education professional who will verbally encourage participants throughout these steps and perform the load adjustment at week 5 and 10 (Radaelli, 2014).
arm group label: Strength exercise with KAATSU
arm group label: Traditional strength exercise
other name: 1RM Test (Knee extension and Seated leg press)
intervention type: Procedure
intervention name: Speed gait test
description: To measure the gait speed of participants they will walk 4.6 metres and the time needed to cover this distance is measured. The mean of three attempts is recorded and divided by the distance. The participants included must achieve in the walking test an average of < 0.,9 m/s (Guralnik, 1994).
arm group label: Strength exercise with KAATSU
arm group label: Traditional strength exercise
intervention type: Device
intervention name: Venous occlusion plethysmography protocol
description: A mercury-filled silastic tube, connected to a low-pressure transducer and a plethysmograph (D.E. Hokanson), will be placed around the largest circumference of the calf region. One cuff will be placed around the ankle and another around the thigh. The ankle cuff will be inflated to a supra-systolic pressure 30 seconds before starting the measurements. At 15-second intervals, the cuff around the thigh will be inflated above the venous pressure for a period of seven to eight seconds. Increased tension in the silastic tube reflects an increase in leg volume and vasodilation. The signal of the muscle blood flow wave will be recorded on a polygraph and analysed every minute, averaging three records per minute. The protocol will be performed during 5 minutes of rest, 3 minutes isometric exercise and 2 minutes of recovery (Bahia, 2006).
arm group label: Strength exercise with KAATSU
arm group label: Traditional strength exercise
intervention type: Device
intervention name: Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity
description: Arterial stiffness will be estimated from the carotid-femoral aortic pulse wave velocity [33]. Carotid-femoral aortic pulse waves will be recorded by tonometry (SphygmoCor, AtCor Medical, Australia). At the same time, an electrocardiogram will be obtained to calculate the wave transit time. Two distances will be measured: the recording point of the carotid artery and the sternal furcula (distance 1) and the sternal furcula and the recording point in the femoral artery (distance 2). The distance travelled by the pulse wave will be calculated as "distance 2" - "distance 1". The carotid-femoral aortic pulse wave velocity will be calculated as: carotid-femoral aortic pulse wave velocity = ¼ * distance travelled by the pulse wave (m) / transit time(s).
arm group label: Strength exercise with KAATSU
arm group label: Traditional strength exercise
intervention type: Device
intervention name: Isometric handgrip exercise protocol
description: In a supine position, the maximal voluntary handgrip force will be determined as the highest force in 3 consecutive attempts using a Jamar hydraulic palmar dynamometer (Asimow Engineering, CAL, USA). For activation of the central command, mechanoreceptors and muscular metaboreceptors the individual will perform, after 5 minutes of rest (baseline records), 3 minutes of exercise at 30% MVC. This manoeuvre isolates the activation of muscle metaboreceptors, observing the selective activation of these. After the isometric handgrip exercise, 2 minutes of recovery will be performed. Throughout the protocol muscle blood flow, blood pressure and heart rate will be recorded.
arm group label: Strength exercise with KAATSU
arm group label: Traditional strength exercise
intervention type: Device
intervention name: Vasodilatory capacity
description: The vasodilatory capacity will be calculated as the percentage of increase of the diameter of the brachial artery and femoral post occlusion in relation to its basal values.
arm group label: Strength exercise with KAATSU
arm group label: Traditional strength exercise
intervention type: Device
intervention name: Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)
description: Images of the brachial artery will be recorded by a two-dimensional ultrasonography device with a spectral Doppler and linear transducer (Ultra-0122, Philips, The Netherlands).
arm group label: Strength exercise with KAATSU
arm group label: Traditional strength exercise
intervention type: Diagnostic Test
intervention name: Quality of Life EuroQol-5 Domain
description: This questionnaire is used to estimate the quality of life in participants before and after the study.
arm group label: Strength exercise with KAATSU
arm group label: Traditional strength exercise
intervention type: Other
intervention name: Anthropometric Assessment
description: Anthropometric measurements will be made before and after the training program following the standardization of the International Society for Anthropometric Assessments. The body mass will be measured with an accuracy of 0.1 kg (Filizola). The stature will be obtained by means of the stadiometer with an accuracy of 0.5 cm. The BMI will be calculated as body mass divided by height squared. The circumference of the quadriceps will be measured with a tape measure (Seca) with a precision of 0.1 cm.
arm group label: Strength exercise with KAATSU
arm group label: Traditional strength exercise
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luciana D Janot, Phd
role: Principal Investigator
affiliation: Hospital Israelita Albert Einstein
facility: 
country: Brazil
citation: Willoughby, D.S. American College of Sports Medicine. ACSM current comment: Resistance Training and the Older Adult. 2012.
citation: Amano S, Ludin AF, Clift R, Nakazawa M, Law TD, Rush LJ, Manini TM, Thomas JS, Russ DW, Clark BC. Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 12;17:81. doi: 10.1186/s13063-016-1214-7.
PMID: 26867541
citation: Bahia L, de Aguiar LG, Villela NR, Bottino D, Bouskela E. [The endothelium in the metabolic syndrome]. Arq Bras Endocrinol Metabol. 2006 Apr;50(2):291-303. doi: 10.1590/s0004-27302006000200015. Epub 2006 May 23. Erratum In: Arq Bras Endocrinol Metabol. 2006 Jun;50(3):574. Portuguese.
PMID: 16767295
citation: Brucki SM, Nitrini R, Caramelli P, Bertolucci PH, Okamoto IH. [Suggestions for utilization of the mini-mental state examination in Brazil]. Arq Neuropsiquiatr. 2003 Sep;61(3B):777-81. doi: 10.1590/s0004-282x2003000500014. Epub 2003 Oct 28. Portuguese.
PMID: 14595482
citation: Cadore EL, Rodriguez-Manas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397.
PMID: 23327448
citation: Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011 Apr 5;57(14):1511-22. doi: 10.1016/j.jacc.2010.12.017.
PMID: 21453829
citation: Chen X, Mao G, Leng SX. Frailty syndrome: an overview. Clin Interv Aging. 2014 Mar 19;9:433-41. doi: 10.2147/CIA.S45300. eCollection 2014.
PMID: 24672230
citation: Crenshaw AG, Hargens AR, Gershuni DH, Rydevik B. Wide tourniquet cuffs more effective at lower inflation pressures. Acta Orthop Scand. 1988 Aug;59(4):447-51. doi: 10.3109/17453678809149401.
PMID: 3421083
citation: D'Antona G, Pellegrino MA, Adami R, Rossi R, Carlizzi CN, Canepari M, Saltin B, Bottinelli R. The effect of ageing and immobilization on structure and function of human skeletal muscle fibres. J Physiol. 2003 Oct 15;552(Pt 2):499-511. doi: 10.1113/jphysiol.2003.046276.
PMID: 14561832
citation: Dobrosielski DA, Greenway FL, Welsh DA, Jazwinski SM, Welsch MA; Louisiana Healthy Aging Study. Modification of vascular function after handgrip exercise training in 73- to 90-yr-old men. Med Sci Sports Exerc. 2009 Jul;41(7):1429-35. doi: 10.1249/MSS.0b013e318199bef4.
PMID: 19516158
citation: Esmon CT. Basic mechanisms and pathogenesis of venous thrombosis. Blood Rev. 2009 Sep;23(5):225-9. doi: 10.1016/j.blre.2009.07.002.
PMID: 19683659
citation: Fahs CA, Rossow LM, Thiebaud RS, Loenneke JP, Kim D, Abe T, Beck TW, Feeback DL, Bemben DA, Bemben MG. Vascular adaptations to low-load resistance training with and without blood flow restriction. Eur J Appl Physiol. 2014 Apr;114(4):715-24. doi: 10.1007/s00421-013-2808-3. Epub 2013 Dec 31.
PMID: 24375201
citation: Fielding RA, Rejeski WJ, Blair S, Church T, Espeland MA, Gill TM, Guralnik JM, Hsu FC, Katula J, King AC, Kritchevsky SB, McDermott MM, Miller ME, Nayfield S, Newman AB, Williamson JD, Bonds D, Romashkan S, Hadley E, Pahor M; LIFE Research Group. The Lifestyle Interventions and Independence for Elders Study: design and methods. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1226-37. doi: 10.1093/gerona/glr123. Epub 2011 Aug 8.
PMID: 21825283
citation: Fried LP, Carlson MC, Freedman M, Frick KD, Glass TA, Hill J, McGill S, Rebok GW, Seeman T, Tielsch J, Wasik BA, Zeger S. A social model for health promotion for an aging population: initial evidence on the Experience Corps model. J Urban Health. 2004 Mar;81(1):64-78. doi: 10.1093/jurban/jth094.
PMID: 15047786
citation: Fry CS, Glynn EL, Drummond MJ, Timmerman KL, Fujita S, Abe T, Dhanani S, Volpi E, Rasmussen BB. Blood flow restriction exercise stimulates mTORC1 signaling and muscle protein synthesis in older men. J Appl Physiol (1985). 2010 May;108(5):1199-209. doi: 10.1152/japplphysiol.01266.2009. Epub 2010 Feb 11.
PMID: 20150565
citation: Frontera WR, Suh D, Krivickas LS, Hughes VA, Goldstein R, Roubenoff R. Skeletal muscle fiber quality in older men and women. Am J Physiol Cell Physiol. 2000 Sep;279(3):C611-8. doi: 10.1152/ajpcell.2000.279.3.C611.
PMID: 10942711
citation: Fujimoto N, Prasad A, Hastings JL, Arbab-Zadeh A, Bhella PS, Shibata S, Palmer D, Levine BD. Cardiovascular effects of 1 year of progressive and vigorous exercise training in previously sedentary individuals older than 65 years of age. Circulation. 2010 Nov 2;122(18):1797-805. doi: 10.1161/CIRCULATIONAHA.110.973784. Epub 2010 Oct 18.
PMID: 20956204
citation: Gates PE, Tanaka H, Graves J, Seals DR. Left ventricular structure and diastolic function with human ageing. Relation to habitual exercise and arterial stiffness. Eur Heart J. 2003 Dec;24(24):2213-20. doi: 10.1016/j.ehj.2003.09.026.
PMID: 14659773
citation: Golbidi S, Laher I. Exercise and the aging endothelium. J Diabetes Res. 2013;2013:789607. doi: 10.1155/2013/789607. Epub 2013 Aug 1.
PMID: 23984434
citation: Graham B, Breault MJ, McEwen JA, McGraw RW. Occlusion of arterial flow in the extremities at subsystolic pressures through the use of wide tourniquet cuffs. Clin Orthop Relat Res. 1993 Jan;(286):257-61.
PMID: 8425355
citation: Harris RA, Nishiyama SK, Wray DW, Richardson RS. Ultrasound assessment of flow-mediated dilation. Hypertension. 2010 May;55(5):1075-85. doi: 10.1161/HYPERTENSIONAHA.110.150821. Epub 2010 Mar 29.
PMID: 20351340
citation: Horiuchi M, Okita K. Blood flow restricted exercise and vascular function. Int J Vasc Med. 2012;2012:543218. doi: 10.1155/2012/543218. Epub 2012 Oct 22.
PMID: 23133756
citation: Karabulut M, Sherk VD, Bemben DA, Bemben MG. Inflammation marker, damage marker and anabolic hormone responses to resistance training with vascular restriction in older males. Clin Physiol Funct Imaging. 2013 Sep;33(5):393-9. doi: 10.1111/cpf.12044. Epub 2013 Apr 23.
PMID: 23701309
citation: Kovacic JC, Moreno P, Nabel EG, Hachinski V, Fuster V. Cellular senescence, vascular disease, and aging: part 2 of a 2-part review: clinical vascular disease in the elderly. Circulation. 2011 May 3;123(17):1900-10. doi: 10.1161/CIRCULATIONAHA.110.009118. No abstract available.
PMID: 21537006
citation: Zembron-Lacny A, Dziubek W, Rogowski L, Skorupka E, Dabrowska G. Sarcopenia: monitoring, molecular mechanisms, and physical intervention. Physiol Res. 2014;63(6):683-91. doi: 10.33549/physiolres.932692. Epub 2014 Aug 26.
PMID: 25157651
citation: Lexell J. Human aging, muscle mass, and fiber type composition. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:11-6. doi: 10.1093/gerona/50a.special_issue.11.
PMID: 7493202
citation: Libardi CA, Chacon-Mikahil MP, Cavaglieri CR, Tricoli V, Roschel H, Vechin FC, Conceicao MS, Ugrinowitsch C. Effect of concurrent training with blood flow restriction in the elderly. Int J Sports Med. 2015 May;36(5):395-9. doi: 10.1055/s-0034-1390496. Epub 2015 Feb 20.
PMID: 25700103
citation: Loenneke JP, Fahs CA, Rossow LM, Thiebaud RS, Mattocks KT, Abe T, Bemben MG. Blood flow restriction pressure recommendations: a tale of two cuffs. Front Physiol. 2013 Sep 10;4:249. doi: 10.3389/fphys.2013.00249. eCollection 2013. No abstract available.
PMID: 24058346
citation: Manini TM, Yarrow JF, Buford TW, Clark BC, Conover CF, Borst SE. Growth hormone responses to acute resistance exercise with vascular restriction in young and old men. Growth Horm IGF Res. 2012 Oct;22(5):167-72. doi: 10.1016/j.ghir.2012.05.002. Epub 2012 Jun 23.
PMID: 22727808
citation: Manini TM, Visser M, Won-Park S, Patel KV, Strotmeyer ES, Chen H, Goodpaster B, De Rekeneire N, Newman AB, Simonsick EM, Kritchevsky SB, Ryder K, Schwartz AV, Harris TB. Knee extension strength cutpoints for maintaining mobility. J Am Geriatr Soc. 2007 Mar;55(3):451-7. doi: 10.1111/j.1532-5415.2007.01087.x.
PMID: 17341251
citation: Mattar MA, Gualano B, Perandini LA, Shinjo SK, Lima FR, Sa-Pinto AL, Roschel H. Safety and possible effects of low-intensity resistance training associated with partial blood flow restriction in polymyositis and dermatomyositis. Arthritis Res Ther. 2014 Oct 25;16(5):473. doi: 10.1186/s13075-014-0473-5.
PMID: 25344395
citation: Miljkovic N, Lim JY, Miljkovic I, Frontera WR. Aging of skeletal muscle fibers. Ann Rehabil Med. 2015 Apr;39(2):155-62. doi: 10.5535/arm.2015.39.2.155. Epub 2015 Apr 24.
PMID: 25932410
citation: de Souza ER, Correia BS. [Construction of indicators for assessing the policy of reducing accidents and violence for the elderly care]. Cien Saude Colet. 2010 Sep;15(6):2753-62. doi: 10.1590/s1413-81232010000600013. Portuguese.
PMID: 20922284
citation: Moore A, Mangoni AA, Lyons D, Jackson SH. The cardiovascular system. Br J Clin Pharmacol. 2003 Sep;56(3):254-60. doi: 10.1046/j.0306-5251.2003.01876.x.
PMID: 12919173
citation: Nakajima, T. et al. Effects of Exercise and Anti-Aging. Anti-Aging Medicine. 2011. v. 7 n. 8. p. 92-102.
citation: Nakajima, T. et al. Effects of low intensity Kaatsu resistance training on skeletal muscle size/strength and endurance capacity in patients with ischemic heart diseases. International Journal of Kaatsu Training Research. 2010. v. 6. p. 1-7.
citation: Nakajima, T. et al. Use and safety of KAATSU training; Results of a national survey. International Journal of Kaatsu Training Research. 2006. v. 2. p. 5-13
citation: Nazari-Shafti TZ, Cooke JP. Telomerase Therapy to Reverse Cardiovascular Senescence. Methodist Debakey Cardiovasc J. 2015 Jul-Sep;11(3):172-5. doi: 10.14797/mdcj-11-3-172.
PMID: 26634025
citation: Norton K.; Olds T. International Standards for Anthropometric Assessment. 1a ed. Austrália: The International Society for the Advancement of Kinanthropometry; 1996.
citation: Odden MC, Peralta CA, Haan MN, Covinsky KE. Rethinking the association of high blood pressure with mortality in elderly adults: the impact of frailty. Arch Intern Med. 2012 Aug 13;172(15):1162-8. doi: 10.1001/archinternmed.2012.2555.
PMID: 22801930
citation: Ozaki H, Loenneke JP, Thiebaud RS, Stager JM, Abe T. Possibility of leg muscle hypertrophy by ambulation in older adults: a brief review. Clin Interv Aging. 2013;8:369-75. doi: 10.2147/CIA.S43837. Epub 2013 Mar 31.
PMID: 23573066
citation: Park DC, Yeo SG. Aging. Korean J Audiol. 2013 Sep;17(2):39-44. doi: 10.7874/kja.2013.17.2.39. Epub 2013 Sep 24.
PMID: 24653904
citation: Park SY, Kwak YS, Harveson A, Weavil JC, Seo KE. Low intensity resistance exercise training with blood flow restriction: insight into cardiovascular function, and skeletal muscle hypertrophy in humans. Korean J Physiol Pharmacol. 2015 May;19(3):191-6. doi: 10.4196/kjpp.2015.19.3.191. Epub 2015 Apr 30.
PMID: 25954122
citation: Radaelli R, Botton CE, Wilhelm EN, Bottaro M, Brown LE, Lacerda F, Gaya A, Moraes K, Peruzzolo A, Pinto RS. Time course of low- and high-volume strength training on neuromuscular adaptations and muscle quality in older women. Age (Dordr). 2014 Apr;36(2):881-92. doi: 10.1007/s11357-013-9611-2. Epub 2014 Jan 11.
PMID: 24414336
citation: Martinez-Ramirez A, Martinikorena I, Gomez M, Lecumberri P, Millor N, Rodriguez-Manas L, Garcia Garcia FJ, Izquierdo M. Frailty assessment based on trunk kinematic parameters during walking. J Neuroeng Rehabil. 2015 May 24;12:48. doi: 10.1186/s12984-015-0040-6.
PMID: 26003560
citation: Ray CA, Rea RF, Clary MP, Mark AL. Muscle sympathetic nerve responses to dynamic one-legged exercise: effect of body posture. Am J Physiol. 1993 Jan;264(1 Pt 2):H1-7. doi: 10.1152/ajpheart.1993.264.1.H1.
PMID: 8430836
citation: Ribeiro, F.A et al. Síndrome metabólica: complacência arterial e a velocidade de onda de pulso. Revista da AMRIGS. 2012. v. 56. n. 1. p. 75-80.
citation: Ricci NA, Pessoa GS, Ferriolli E, Dias RC, Perracini MR. Frailty and cardiovascular risk in community-dwelling elderly: a population-based study. Clin Interv Aging. 2014 Oct 6;9:1677-85. doi: 10.2147/CIA.S68642. eCollection 2014.
PMID: 25336932
citation: Russ DW, Grandy JS, Toma K, Ward CW. Ageing, but not yet senescent, rats exhibit reduced muscle quality and sarcoplasmic reticulum function. Acta Physiol (Oxf). 2011 Mar;201(3):391-403. doi: 10.1111/j.1748-1716.2010.02191.x. Epub 2010 Nov 9.
PMID: 20874807
citation: Satoh, I. Kaatsu Training: Application to Metabolic Syndrome. 2011. International Journal of Kaatsu Training Research. 2011. v. 7. p. 7-12.
citation: Raskob GE, Angchaisuksiri P, Blanco AN, Buller H, Gallus A, Hunt BJ, Hylek EM, Kakkar A, Konstantinides SV, McCumber M, Ozaki Y, Wendelboe A, Weitz JI; ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to global disease burden. Arterioscler Thromb Vasc Biol. 2014 Nov;34(11):2363-71. doi: 10.1161/ATVBAHA.114.304488.
PMID: 25304324
citation: Scott BR, Loenneke JP, Slattery KM, Dascombe BJ. Blood flow restricted exercise for athletes: A review of available evidence. J Sci Med Sport. 2016 May;19(5):360-7. doi: 10.1016/j.jsams.2015.04.014. Epub 2015 May 9.
PMID: 26118847
citation: Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26.
PMID: 24864078
citation: Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097.
PMID: 10846023
citation: Thijssen DH, Black MA, Pyke KE, Padilla J, Atkinson G, Harris RA, Parker B, Widlansky ME, Tschakovsky ME, Green DJ. Assessment of flow-mediated dilation in humans: a methodological and physiological guideline. Am J Physiol Heart Circ Physiol. 2011 Jan;300(1):H2-12. doi: 10.1152/ajpheart.00471.2010. Epub 2010 Oct 15.
PMID: 20952670
citation: Verdijk LB, Koopman R, Schaart G, Meijer K, Savelberg HH, van Loon LJ. Satellite cell content is specifically reduced in type II skeletal muscle fibers in the elderly. Am J Physiol Endocrinol Metab. 2007 Jan;292(1):E151-7. doi: 10.1152/ajpendo.00278.2006. Epub 2006 Aug 22.
PMID: 16926381
citation: Villacorta H, Bortolotto LA, Arteaga E, Mady C. Aortic distensibility measured by pulse-wave velocity is not modified in patients with Chagas' disease. J Negat Results Biomed. 2006 Jun 12;5:9. doi: 10.1186/1477-5751-5-9.
PMID: 16768804
citation: Wernbom, M. Effects of an acute bout of low-load resistance training with blood flow restriction. 2011. 206 f. Dissertation. The Norwegian School of Sports Sciences. Noruega. 2011.
citation: World Health Organization. Global brief for World Health Day. 2012. http://www.who.int/world_health_day/2012.
citation: Wu IC, Lin CC, Hsiung CA. Emerging roles of frailty and inflammaging in risk assessment of age-related chronic diseases in older adults: the intersection between aging biology and personalized medicine. Biomedicine (Taipei). 2015;5(1):1. doi: 10.7603/s40681-015-0001-1. Epub 2015 Feb 2.
PMID: 25722960
citation: Yasuda T, Loenneke JP, Thiebaud RS, Abe T. Effects of blood flow restricted low-intensity concentric or eccentric training on muscle size and strength. PLoS One. 2012;7(12):e52843. doi: 10.1371/journal.pone.0052843. Epub 2012 Dec 31.
PMID: 23300795
citation: Yasuda T, Fukumura K, Iida H, Nakajima T. Effects of detraining after blood flow-restricted low-load elastic band training on muscle size and arterial stiffness in older women. Springerplus. 2015 Jul 15;4:348. doi: 10.1186/s40064-015-1132-2. eCollection 2015.
PMID: 26191475
citation: Yasuda T, Fukumura K, Uchida Y, Koshi H, Iida H, Masamune K, Yamasoba T, Sato Y, Nakajima T. Effects of Low-Load, Elastic Band Resistance Training Combined With Blood Flow Restriction on Muscle Size and Arterial Stiffness in Older Adults. J Gerontol A Biol Sci Med Sci. 2015 Aug;70(8):950-8. doi: 10.1093/gerona/glu084. Epub 2014 Jun 10.
PMID: 24917178
citation: Yokokawa Y, Hongo M, Urayama H, Nishimura T, Kai I. Effects of low-intensity resistance exercise with vascular occlusion on physical function in healthy elderly people. Biosci Trends. 2008 Jun;2(3):117-23.
PMID: 20103914
citation: Nakajima, T.; Morita, T.; Sato, Y. Key considerations when conducting KAATSU training. International Journal of Kaatsu Training Research. 2011. v. 7. p. 1-6.
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submitted: June 23, 2022
returned: July 19, 2022