<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/NCT03840330</url>
  </required_header>
  <id_info>
    <org_study_id>HIICT-OW/16</org_study_id>
    <nct_id>NCT03840330</nct_id>
  </id_info>
  <brief_title>High-intensity Training for Improving Physical Performance of Aged Women</brief_title>
  <acronym>AHIITATE</acronym>
  <official_title>Effects of High-intensity Interval Circuit Training (HIICT) on the Cardiovascular and Functional Parameters of Aged Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Almeria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Almeria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the adaptations on the functional capacity and cardiovascular in elderly&#xD;
      after a physical activity program circuit training. The participants were divided into three&#xD;
      groups: Circuit training based on high-intensity interval training group (HIICT), Circuit&#xD;
      training at moderate intensity group (MICT) and Control group (CG).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three groups of participants (circuit training based on high-intensity interval training,&#xD;
      circuit training at moderate intensity and not training group) will enter the study. The&#xD;
      intervention will consist of a physical exercise program in day centers.&#xD;
&#xD;
      Intensity progression will be encouraged according to the rate of perceived exertion.&#xD;
      Progression of exertion will be &quot;very hard&quot;, &quot;extremely hard&quot; and &quot;maximal exertion&quot; for HIT&#xD;
      group, and &quot;light&quot;, &quot;somewhat hard&quot; and &quot;hard&quot; for group. Assessment will be undertaken at&#xD;
      two-time points: baseline and after 16 weeks of exercise training.&#xD;
&#xD;
      Assessment will include VO2 peak, functional capacity, health-related quality of life,&#xD;
      cognitive state and daily physical activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2015</start_date>
  <completion_date type="Actual">June 20, 2016</completion_date>
  <primary_completion_date type="Actual">February 1, 2016</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>HIT; MIT; GC</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analyses changes in maximum oxygen consumption (VO2max).</measure>
    <time_frame>Pre and post after sixteen weeks of intervention</time_frame>
    <description>A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2max).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analyses changes in maximum oxygen consumption (VO2max).</measure>
    <time_frame>Pre and post after sixteen weeks of intervention</time_frame>
    <description>VO2max was assessed using the 6-Minute Walk Test. The participant should walk the longest distance possible in 6 minutes by walking continuously the 42 metres indicated on the floor. It measures the distance in meters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in heart rate reached in ergometry.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention</time_frame>
    <description>Analyses during modified Balke treadmill protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in blood pressure reached in ergometry.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention</time_frame>
    <description>Analyses during modified Balke treadmill protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in maximum speed reached in ergometry.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention</time_frame>
    <description>Analyses during modified Balke treadmill protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in duration test reached in ergometry.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention</time_frame>
    <description>Analyses during modified Balke treadmill protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in fat percentage.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention.</time_frame>
    <description>Fat percentage (%) was assessed using bioimpedance analysis (OMROM BF-306).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in body mass index (BMI).</measure>
    <time_frame>Pre and post after sixteen weeks of intervention.</time_frame>
    <description>BMI was assessed using bioimpedance analysis (OMROM BF-306).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in gait.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention.</time_frame>
    <description>Gait was assessed using the Timed Up and Go Test. To stand up from a standard arms chair, walk 3 meters, turn back the cone walk back and sit down to the chair. The time in seconds is record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in balance.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention.</time_frame>
    <description>Balance was assessed using the One Leg Standing Test. This test consist in maintain one leg stance for as long as possible. The test was considered normal if the one leg standing time reached 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in lower body strength.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention.</time_frame>
    <description>Lower body strength was assessed using the Sit To Stand 30. For the Sit To Stand 30, the participant consist in measures how many repetition the participant can to stand up and sit down during 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in upper body strength.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention.</time_frame>
    <description>Upper body strength was assessed using the Arm Curl Test (30). For this test, the participant consist in measures how many repetition the participant can to curl up and curl down during 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyses changes in maximal handgrip strength.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention.</time_frame>
    <description>To measure the amount of strength developed by each hand in kg.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Analyses change in Self Assessed Physical Activity.</measure>
    <time_frame>Pre and post after sixteen weeks of intervention.</time_frame>
    <description>Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Aging</condition>
  <condition>Healthy</condition>
  <condition>Cardiovascular Risk Factor</condition>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>High-intensity interval training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Frequency: 2 days/weeks; Intensity: 16-18 Börg/85-100%VO2max; Recovery: Active; Duration: 1 hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate-intensity interval training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Frequency: 2 days/weeks; Intensity: 12-14 Börg/60-70% VO2max; Recovery: Active; Duration: 1 hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Maintain their normal daily activities throughout the sixteen-week experimental period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental: High-intensity interval training group</intervention_name>
    <description>16 weeks of High-intensity interval training</description>
    <arm_group_label>High-intensity interval training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Experimental: Moderate-intensity interval training group</intervention_name>
    <description>16 weeks of Moderate-intensity interval training</description>
    <arm_group_label>Moderate-intensity interval training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Having 50 - 90 years old.&#xD;
&#xD;
          2. Not suffering chronic heart, respiratory or joint disease, taking medication or having&#xD;
             a deteriorated level of mental health that could interfere in carrying out exercise&#xD;
             programs.&#xD;
&#xD;
          3. Having 0 or 1 responses positive in the Physical Activity Readiness Questionnaire&#xD;
             (ParQ). Only item 6, related to mild vascular diseases.&#xD;
&#xD;
          4. Being physically independent according to the scales Lawton and Brody, and Katz.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Having uncontrolled arterial hypertension.&#xD;
&#xD;
          2. Having practiced during the previous 3 months or practicing at present a similar&#xD;
             exercise to the one proposed in the study.&#xD;
&#xD;
          3. Attending sessions less than 80%.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismael Ballesta García, PhD. Student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Almeria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>María Carrasco Poyatos, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Almeria</affiliation>
  </overall_official>
  <link>
    <url>http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S0212-16112016000600008</url>
    <description>Carrasco, M., Navarro, M.D., Martínez, I., Reche-Orenes, D. (2016). Daily physical activity impact in old women bone density and grip strength. Nutrición Hospitalaria, 33(6), 1305-1311.</description>
  </link>
  <link>
    <url>http://www.scielo.br/scielo.php?script=sci_arttext&amp;pid=S1517-86922015000100022</url>
    <description>Carrasco, M., Martínez, I., Navarro, M.D. (2015). Daily physical activity and bone mineral density in older women. Revista Brasileira de Medicina do Esporte, 21(1), 22-26.</description>
  </link>
  <results_reference>
    <citation>Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.</citation>
    <PMID>17548726</PMID>
  </results_reference>
  <results_reference>
    <citation>Guiraud T, Juneau M, Nigam A, Gayda M, Meyer P, Mekary S, Paillard F, Bosquet L. Optimization of high intensity interval exercise in coronary heart disease. Eur J Appl Physiol. 2010 Mar;108(4):733-40. doi: 10.1007/s00421-009-1287-z.</citation>
    <PMID>19915859</PMID>
  </results_reference>
  <results_reference>
    <citation>Huang SC, Wong MK, Lin PJ, Tsai FC, Fu TC, Wen MS, Kuo CT, Wang JS. Modified high-intensity interval training increases peak cardiac power output in patients with heart failure. Eur J Appl Physiol. 2014 Sep;114(9):1853-62. doi: 10.1007/s00421-014-2913-y. Epub 2014 Jun 1.</citation>
    <PMID>24880226</PMID>
  </results_reference>
  <results_reference>
    <citation>Ballesta Garcia I, Rubio Arias JA, Ramos Campo DJ, Martinez Gonzalez-Moro I, Carrasco Poyatos M. High-intensity Interval Training Dosage for Heart Failure and Coronary Artery Disease Cardiac Rehabilitation. A Systematic Review and Meta-analysis. Rev Esp Cardiol (Engl Ed). 2019 Mar;72(3):233-243. doi: 10.1016/j.rec.2018.02.015. Epub 2018 Apr 9. English, Spanish.</citation>
    <PMID>29650445</PMID>
  </results_reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 5, 2018</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 4, 2019</last_update_submitted>
  <last_update_submitted_qc>March 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Almeria</investigator_affiliation>
    <investigator_full_name>María Carrasco Poyatos</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>High-intensity interval training</keyword>
  <keyword>Circuit training</keyword>
  <keyword>Elderly</keyword>
  <keyword>Functional capacity</keyword>
  <keyword>VO2 max</keyword>
  <keyword>Cardiovascular parameters</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 10, 2010</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03840330/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03840330
org study id: HIICT-OW/16
nct id: NCT03840330
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the adaptations on the functional capacity and cardiovascular in elderly
      after a physical activity program circuit training. The participants were divided into three
      groups: Circuit training based on high-intensity interval training group (HIICT), Circuit
      training at moderate intensity group (MICT) and Control group (CG).
Three groups of participants (circuit training based on high-intensity interval training,
      circuit training at moderate intensity and not training group) will enter the study. The
      intervention will consist of a physical exercise program in day centers.

      Intensity progression will be encouraged according to the rate of perceived exertion.
      Progression of exertion will be "very hard", "extremely hard" and "maximal exertion" for HIT
      group, and "light", "somewhat hard" and "hard" for group. Assessment will be undertaken at
      two-time points: baseline and after 16 weeks of exercise training.

      Assessment will include VO2 peak, functional capacity, health-related quality of life,
      cognitive state and daily physical activity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: HIT; MIT; GC
primary purpose: Basic Science
masking: None (Open Label)
measure: Analyses changes in maximum oxygen consumption (VO2max).
time frame: Pre and post after sixteen weeks of intervention
description: A modified Balke treadmill protocol will be used to estimate aerobic capacity (VO2max).
measure: Analyses changes in maximum oxygen consumption (VO2max).
time frame: Pre and post after sixteen weeks of intervention
description: VO2max was assessed using the 6-Minute Walk Test. The participant should walk the longest distance possible in 6 minutes by walking continuously the 42 metres indicated on the floor. It measures the distance in meters
measure: Analyses changes in heart rate reached in ergometry.
time frame: Pre and post after sixteen weeks of intervention
description: Analyses during modified Balke treadmill protocol
measure: Analyses changes in blood pressure reached in ergometry.
time frame: Pre and post after sixteen weeks of intervention
description: Analyses during modified Balke treadmill protocol
measure: Analyses changes in maximum speed reached in ergometry.
time frame: Pre and post after sixteen weeks of intervention
description: Analyses during modified Balke treadmill protocol
measure: Analyses changes in duration test reached in ergometry.
time frame: Pre and post after sixteen weeks of intervention
description: Analyses during modified Balke treadmill protocol
measure: Analyses changes in fat percentage.
time frame: Pre and post after sixteen weeks of intervention.
description: Fat percentage (%) was assessed using bioimpedance analysis (OMROM BF-306).
measure: Analyses changes in body mass index (BMI).
time frame: Pre and post after sixteen weeks of intervention.
description: BMI was assessed using bioimpedance analysis (OMROM BF-306).
measure: Analyses changes in gait.
time frame: Pre and post after sixteen weeks of intervention.
description: Gait was assessed using the Timed Up and Go Test. To stand up from a standard arms chair, walk 3 meters, turn back the cone walk back and sit down to the chair. The time in seconds is record.
measure: Analyses changes in balance.
time frame: Pre and post after sixteen weeks of intervention.
description: Balance was assessed using the One Leg Standing Test. This test consist in maintain one leg stance for as long as possible. The test was considered normal if the one leg standing time reached 30 seconds.
measure: Analyses changes in lower body strength.
time frame: Pre and post after sixteen weeks of intervention.
description: Lower body strength was assessed using the Sit To Stand 30. For the Sit To Stand 30, the participant consist in measures how many repetition the participant can to stand up and sit down during 30 seconds.
measure: Analyses changes in upper body strength.
time frame: Pre and post after sixteen weeks of intervention.
description: Upper body strength was assessed using the Arm Curl Test (30). For this test, the participant consist in measures how many repetition the participant can to curl up and curl down during 30 seconds.
measure: Analyses changes in maximal handgrip strength.
time frame: Pre and post after sixteen weeks of intervention.
description: To measure the amount of strength developed by each hand in kg.
measure: Analyses change in Self Assessed Physical Activity.
time frame: Pre and post after sixteen weeks of intervention.
description: Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.
arm group label: High-intensity interval training group
arm group type: Experimental
description: Frequency: 2 days/weeks; Intensity: 16-18 Börg/85-100%VO2max; Recovery: Active; Duration: 1 hour.
arm group label: Moderate-intensity interval training group
arm group type: Experimental
description: Frequency: 2 days/weeks; Intensity: 12-14 Börg/60-70% VO2max; Recovery: Active; Duration: 1 hour.
arm group label: Control group
arm group type: No Intervention
description: Maintain their normal daily activities throughout the sixteen-week experimental period.
intervention type: Other
intervention name: Experimental: High-intensity interval training group
description: 16 weeks of High-intensity interval training
arm group label: High-intensity interval training group
intervention type: Other
intervention name: Experimental: Moderate-intensity interval training group
description: 16 weeks of Moderate-intensity interval training
arm group label: Moderate-intensity interval training group
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ismael Ballesta García, PhD. Student
role: Principal Investigator
affiliation: Universidad de Almeria
last name: María Carrasco Poyatos, PhD.
role: Principal Investigator
affiliation: Universidad de Almeria
url: http://scielo.isciii.es/scielo.php?script=sci_abstract&pid=S0212-16112016000600008
description: Carrasco, M., Navarro, M.D., Martínez, I., Reche-Orenes, D. (2016). Daily physical activity impact in old women bone density and grip strength. Nutrición Hospitalaria, 33(6), 1305-1311.
url: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1517-86922015000100022
description: Carrasco, M., Martínez, I., Navarro, M.D. (2015). Daily physical activity and bone mineral density in older women. Revista Brasileira de Medicina do Esporte, 21(1), 22-26.
citation: Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.
PMID: 17548726
citation: Guiraud T, Juneau M, Nigam A, Gayda M, Meyer P, Mekary S, Paillard F, Bosquet L. Optimization of high intensity interval exercise in coronary heart disease. Eur J Appl Physiol. 2010 Mar;108(4):733-40. doi: 10.1007/s00421-009-1287-z.
PMID: 19915859
citation: Huang SC, Wong MK, Lin PJ, Tsai FC, Fu TC, Wen MS, Kuo CT, Wang JS. Modified high-intensity interval training increases peak cardiac power output in patients with heart failure. Eur J Appl Physiol. 2014 Sep;114(9):1853-62. doi: 10.1007/s00421-014-2913-y. Epub 2014 Jun 1.
PMID: 24880226
citation: Ballesta Garcia I, Rubio Arias JA, Ramos Campo DJ, Martinez Gonzalez-Moro I, Carrasco Poyatos M. High-intensity Interval Training Dosage for Heart Failure and Coronary Artery Disease Cardiac Rehabilitation. A Systematic Review and Meta-analysis. Rev Esp Cardiol (Engl Ed). 2019 Mar;72(3):233-243. doi: 10.1016/j.rec.2018.02.015. Epub 2018 Apr 9. English, Spanish.
PMID: 29650445
responsible party type: Principal Investigator
investigator affiliation: Universidad de Almeria
investigator full name: María Carrasco Poyatos
investigator title: Principal Investigator
provided document: 