<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/NCT03837639</url>
  </required_header>
  <id_info>
    <org_study_id>PAD01</org_study_id>
    <nct_id>NCT03837639</nct_id>
  </id_info>
  <brief_title>Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease</brief_title>
  <official_title>Effects of Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Israelita Albert Einstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northumbria University</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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to analyze the effect of 12 weeks of arm crank exercise (ACE)&#xD;
      training on cardiovascular function in PAD patients, and compare it with treadmill exercise&#xD;
      (TE), the actual recommendation for this patients. In this clinical trial, 45 patients will&#xD;
      be allocated randomly in three experimental groups: ACE training, TE and control group. ACE&#xD;
      and TE groups will perform exercises twice a week with the intensity equivalent to 13- 15 on&#xD;
      Borg's Subjective Perception Exertion Scale. Patients in control group will meet twice a&#xD;
      week, however only to perform diverse activities and group living, without any type of&#xD;
      exercise involved. All groups will be encouraged to increase their levels of activity, as&#xD;
      they are usually guided in medical consultations. Before and after 12 weeks of intervention,&#xD;
      cardiovascular function, functional capacity, cognition, and quality of life will be&#xD;
      assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Arm-crank exercise (ACT) is an alternative exercise strategy for patients with symptomatic&#xD;
      peripheral artery disease (PAD) due the benefits on functional capacity and quality of life,&#xD;
      besides provoking less or no pain symptoms during the execution. This study sought to&#xD;
      describe the protocol of a study that will analyse the effect of ACT exercise on walking&#xD;
      capacity, cardiovascular function, cognition and quality of life in patients with symptomatic&#xD;
      PAD.&#xD;
&#xD;
      This is a three-armed randomized, prospective, single-blind data collection, single-center,&#xD;
      controlled study enrolling 45 patients with symptomatic PAD which will be randomized into 3&#xD;
      intervention groups: walking training (WT), ACT (WT and AC: 15 to 10 sets of 2 to 5 minutes,&#xD;
      Borg 13 to 15) and control group (CG). Before and after 12 weeks of intervention,&#xD;
      cardiovascular function (ambulatory blood pressure , clinic blood pressure, central blood&#xD;
      pressure, heart rate variability, arterial stiffness, vascular function), functional capacity&#xD;
      (six-minute walking test, 2 minute step test [2 MST], Walking impairment questionnaire [WIQ],&#xD;
      Walking estimated limitation calculated by history [WELCH], Baltimore activity scale for&#xD;
      intermittent claudication, handgrip test and short physical performance battery [SPPB]),&#xD;
      cognition (executive function and memory) and quality of life (short version of world health&#xD;
      organization quality of life and vascular quality of life questionnaire [VASCUQOL-6]) will be&#xD;
      assessed.&#xD;
&#xD;
      This is the first trial to evaluate the effects of ACT on regulatory mechanisms of&#xD;
      cardiovascular system in PAD patients. If the results are as expected, they will provide&#xD;
      evidence of ACT in promoting cardiovascular benefits in symptomatic PAD population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 10, 2019</start_date>
  <completion_date type="Anticipated">December 10, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 10, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ambulatory blood pressure</measure>
    <time_frame>Change from baseline in ambulatory blood pressure at 12 weeks</time_frame>
    <description>Systolic, diastolic and mean blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic ambulatory blood pressure monitor (Cardios, São Paulo, Brazil).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinic blood pressure</measure>
    <time_frame>Change from baseline in ambulatory blood pressure at 12 weeks</time_frame>
    <description>Systolic and diastolic brachial blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central blood pressure</measure>
    <time_frame>Change from baseline in ambulatory blood pressure at 12 weeks</time_frame>
    <description>Systolic and diastolic central blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Change from baseline in ambulatory blood pressure at 12 weeks</time_frame>
    <description>Heart rate variability will be measured before and after 12 weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial stiffness</measure>
    <time_frame>Change from baseline in arterial stiffness at 12 weeks</time_frame>
    <description>Carotid femoral pulse wave velocity will be measured before and after 12 weeks of intervention period on intervention and control group by pulse wave velocity measurement with applanation tonometry (SphygmoCor, AtCor Medical, Australia).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular function</measure>
    <time_frame>Change from baseline in flow-mediated vasodilation at 12 weeks</time_frame>
    <description>Flow-meadiated dilation will be measured before and after 12 weeks of intervention period on intervention and control group by a flow mediated dilation measurement with an ultrasound image (HDI 5000 Sono CT, Philips, The Netherlands).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walking capacity</measure>
    <time_frame>Change from baseline in walking distance at 12 weeks</time_frame>
    <description>Six-minute walking test will be measured before and after 12 weeks of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>March in place</measure>
    <time_frame>Change from baseline in the number of the steps at 12 weeks</time_frame>
    <description>Two-minute step test will be measured before and after 12 weeks of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measurement of walking capacity</measure>
    <time_frame>Change from baseline in the walking impairment questionnaire score after 12 weeks</time_frame>
    <description>Walking impairment questionnaire will be measured before and after 12 weeks of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measurement of walking capacity compared to healthy subjects</measure>
    <time_frame>Change from baseline in the Walking estimated limitation calculated by history questionnaire score after 12 weeks</time_frame>
    <description>Walking estimated limitation calculated by history questionnaire will be measured before and after 12 weeks of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall strength test</measure>
    <time_frame>Change from baseline in kgf of the handgrip test after 12 weeks</time_frame>
    <description>Handgrip strength test will be measured before and after 12 weeks of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of intermittent claudication</measure>
    <time_frame>Change from baseline in the Baltimore Activity Scale for Intermittent Claudication score after 12 weeks</time_frame>
    <description>The Baltimore Activity Scale for Intermittent Claudication is a questionnaire that will be measured before and after 12 weeks of intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General functional capacity</measure>
    <time_frame>Change from baseline in the Short Physical Performance Battery score after 12 weeks</time_frame>
    <description>The Short Physical Performance Battery will be measured before and after 12 weeks of intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specific quality of life of vascular patients</measure>
    <time_frame>Change from baseline in the Vascular quality of life questionnaire score after 12 weeks</time_frame>
    <description>The Vascular quality of life questionnaire will be measured before and after 12 weeks of intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General quality of life</measure>
    <time_frame>Change from baseline in the World Health Organization Quality of Life score after 12 weeks</time_frame>
    <description>The World Health Organization Quality of Life questionnaire will be measured before and after 12 weeks of intervention</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Intermittent Claudication</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Arm crank ergometer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm-crank exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill ergometer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Walking exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients randomized to control group will attend to meetings with the researcher team twice a week during the 12 weeks. At these meetings, patients will perform manual tasks, with or without the use of artistic materials, cultural programs, cooking classes and home care, without any exercise component. This CG practice will be performed in order to minimize the effects of the patient's bi- weekly commitment and displacement to the training site, to minimize the influence of the patient- researcher contact and also minimize the convivial effect among the patients themselves, which will occur in the other two groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arm ergometer</intervention_name>
    <description>Arm-crank exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard</description>
    <arm_group_label>Arm crank ergometer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treadmill ergometer</intervention_name>
    <description>Walking exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.</description>
    <arm_group_label>Treadmill ergometer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Patients randomized to control group will attend to meetings with the researcher team twice a week during the 12 weeks. At these meetings, patients will perform manual tasks, with or without the use of artistic materials, cultural programs, cooking classes and home care, without any exercise component. This CG practice will be performed in order to minimize the effects of the patient's bi- weekly commitment and displacement to the training site, to minimize the influence of the patient- researcher contact and also minimize the convivial effect among the patients themselves, which will occur in the other two groups.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PAD stage II&#xD;
&#xD;
          -  Ankle brachial index &lt;0.90 in one or both lower limbs;&#xD;
&#xD;
          -  Women in post-menopause phase without hormone replacement therapy&#xD;
&#xD;
          -  Not an active smoker;&#xD;
&#xD;
          -  Able to perform exercise training;&#xD;
&#xD;
        Patients selected to participate in the study will be only excluded if:&#xD;
&#xD;
          -  Change their medication;&#xD;
&#xD;
          -  Present any health impairment that contraindicates the practice of physical exercise&#xD;
             during the study;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hélcio Kanegusuku, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Israelite Institute for Education and Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Raphael M Ritti-Dias, PhD</last_name>
    <phone>+551999406878</phone>
    <email>raphaelritti@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marilia A Correia, PhD</last_name>
    <phone>+5511999711669</phone>
    <email>marilia.correia@live.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Israelita Albert Einstein</name>
      <address>
        <city>São Paulo</city>
        <zip>05652-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriel Cucato, PhD</last_name>
      <phone>+5511967318023</phone>
      <email>gabriel.grizzo@einstein.br</email>
    </contact>
    <investigator>
      <last_name>Gabriel Cucato, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Cavalcante BR, Ritti-Dias RM, Soares AH, Lima AH, Correia MA, De Matos LD, Gobbi F, Leicht AS, Wolosker N, Cucato GG. A Single Bout of Arm-crank Exercise Promotes Positive Emotions and Post-Exercise Hypotension in Patients with Symptomatic Peripheral Artery Disease. Eur J Vasc Endovasc Surg. 2017 Feb;53(2):223-228. doi: 10.1016/j.ejvs.2016.11.021. Epub 2016 Dec 21.</citation>
    <PMID>28012910</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>December 6, 2021</last_update_submitted>
  <last_update_submitted_qc>December 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>arm-crank</keyword>
  <keyword>exercise training</keyword>
  <keyword>cardiovascular function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Intermittent Claudication</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We are planing to share our data in the future.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After publication of the main paper.</ipd_time_frame>
    <ipd_access_criteria>Ask to authors permision.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03837639
org study id: PAD01
nct id: NCT03837639
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to analyze the effect of 12 weeks of arm crank exercise (ACE)
      training on cardiovascular function in PAD patients, and compare it with treadmill exercise
      (TE), the actual recommendation for this patients. In this clinical trial, 45 patients will
      be allocated randomly in three experimental groups: ACE training, TE and control group. ACE
      and TE groups will perform exercises twice a week with the intensity equivalent to 13- 15 on
      Borg's Subjective Perception Exertion Scale. Patients in control group will meet twice a
      week, however only to perform diverse activities and group living, without any type of
      exercise involved. All groups will be encouraged to increase their levels of activity, as
      they are usually guided in medical consultations. Before and after 12 weeks of intervention,
      cardiovascular function, functional capacity, cognition, and quality of life will be
      assessed.
Arm-crank exercise (ACT) is an alternative exercise strategy for patients with symptomatic
      peripheral artery disease (PAD) due the benefits on functional capacity and quality of life,
      besides provoking less or no pain symptoms during the execution. This study sought to
      describe the protocol of a study that will analyse the effect of ACT exercise on walking
      capacity, cardiovascular function, cognition and quality of life in patients with symptomatic
      PAD.

      This is a three-armed randomized, prospective, single-blind data collection, single-center,
      controlled study enrolling 45 patients with symptomatic PAD which will be randomized into 3
      intervention groups: walking training (WT), ACT (WT and AC: 15 to 10 sets of 2 to 5 minutes,
      Borg 13 to 15) and control group (CG). Before and after 12 weeks of intervention,
      cardiovascular function (ambulatory blood pressure , clinic blood pressure, central blood
      pressure, heart rate variability, arterial stiffness, vascular function), functional capacity
      (six-minute walking test, 2 minute step test [2 MST], Walking impairment questionnaire [WIQ],
      Walking estimated limitation calculated by history [WELCH], Baltimore activity scale for
      intermittent claudication, handgrip test and short physical performance battery [SPPB]),
      cognition (executive function and memory) and quality of life (short version of world health
      organization quality of life and vascular quality of life questionnaire [VASCUQOL-6]) will be
      assessed.

      This is the first trial to evaluate the effects of ACT on regulatory mechanisms of
      cardiovascular system in PAD patients. If the results are as expected, they will provide
      evidence of ACT in promoting cardiovascular benefits in symptomatic PAD population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: ambulatory blood pressure
time frame: Change from baseline in ambulatory blood pressure at 12 weeks
description: Systolic, diastolic and mean blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic ambulatory blood pressure monitor (Cardios, São Paulo, Brazil).
measure: Clinic blood pressure
time frame: Change from baseline in ambulatory blood pressure at 12 weeks
description: Systolic and diastolic brachial blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
measure: Central blood pressure
time frame: Change from baseline in ambulatory blood pressure at 12 weeks
description: Systolic and diastolic central blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
measure: Heart rate variability
time frame: Change from baseline in ambulatory blood pressure at 12 weeks
description: Heart rate variability will be measured before and after 12 weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA).
measure: Arterial stiffness
time frame: Change from baseline in arterial stiffness at 12 weeks
description: Carotid femoral pulse wave velocity will be measured before and after 12 weeks of intervention period on intervention and control group by pulse wave velocity measurement with applanation tonometry (SphygmoCor, AtCor Medical, Australia).
measure: Vascular function
time frame: Change from baseline in flow-mediated vasodilation at 12 weeks
description: Flow-meadiated dilation will be measured before and after 12 weeks of intervention period on intervention and control group by a flow mediated dilation measurement with an ultrasound image (HDI 5000 Sono CT, Philips, The Netherlands).
measure: Walking capacity
time frame: Change from baseline in walking distance at 12 weeks
description: Six-minute walking test will be measured before and after 12 weeks of intervention
measure: March in place
time frame: Change from baseline in the number of the steps at 12 weeks
description: Two-minute step test will be measured before and after 12 weeks of intervention
measure: Subjective measurement of walking capacity
time frame: Change from baseline in the walking impairment questionnaire score after 12 weeks
description: Walking impairment questionnaire will be measured before and after 12 weeks of intervention
measure: Subjective measurement of walking capacity compared to healthy subjects
time frame: Change from baseline in the Walking estimated limitation calculated by history questionnaire score after 12 weeks
description: Walking estimated limitation calculated by history questionnaire will be measured before and after 12 weeks of intervention
measure: Overall strength test
time frame: Change from baseline in kgf of the handgrip test after 12 weeks
description: Handgrip strength test will be measured before and after 12 weeks of intervention
measure: Symptoms of intermittent claudication
time frame: Change from baseline in the Baltimore Activity Scale for Intermittent Claudication score after 12 weeks
description: The Baltimore Activity Scale for Intermittent Claudication is a questionnaire that will be measured before and after 12 weeks of intervention.
measure: General functional capacity
time frame: Change from baseline in the Short Physical Performance Battery score after 12 weeks
description: The Short Physical Performance Battery will be measured before and after 12 weeks of intervention.
measure: Specific quality of life of vascular patients
time frame: Change from baseline in the Vascular quality of life questionnaire score after 12 weeks
description: The Vascular quality of life questionnaire will be measured before and after 12 weeks of intervention.
measure: General quality of life
time frame: Change from baseline in the World Health Organization Quality of Life score after 12 weeks
description: The World Health Organization Quality of Life questionnaire will be measured before and after 12 weeks of intervention
arm group label: Arm crank ergometer
arm group type: Experimental
description: Arm-crank exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.
arm group label: Treadmill ergometer
arm group type: Experimental
description: Walking exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.
arm group label: Control group
arm group type: Other
description: Patients randomized to control group will attend to meetings with the researcher team twice a week during the 12 weeks. At these meetings, patients will perform manual tasks, with or without the use of artistic materials, cultural programs, cooking classes and home care, without any exercise component. This CG practice will be performed in order to minimize the effects of the patient's bi- weekly commitment and displacement to the training site, to minimize the influence of the patient- researcher contact and also minimize the convivial effect among the patients themselves, which will occur in the other two groups.
intervention type: Other
intervention name: Arm ergometer
description: Arm-crank exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard
arm group label: Arm crank ergometer
intervention type: Other
intervention name: Treadmill ergometer
description: Walking exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.
arm group label: Treadmill ergometer
intervention type: Other
intervention name: Control group
description: Patients randomized to control group will attend to meetings with the researcher team twice a week during the 12 weeks. At these meetings, patients will perform manual tasks, with or without the use of artistic materials, cultural programs, cooking classes and home care, without any exercise component. This CG practice will be performed in order to minimize the effects of the patient's bi- weekly commitment and displacement to the training site, to minimize the influence of the patient- researcher contact and also minimize the convivial effect among the patients themselves, which will occur in the other two groups.
arm group label: Control group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: Hélcio Kanegusuku, PhD
role: Study Chair
affiliation: Israelite Institute for Education and Research
last name: Raphael M Ritti-Dias, PhD
phone: +551999406878
email: raphaelritti@gmail.com
last name: Marilia A Correia, PhD
phone: +5511999711669
email: marilia.correia@live.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
citation: Cavalcante BR, Ritti-Dias RM, Soares AH, Lima AH, Correia MA, De Matos LD, Gobbi F, Leicht AS, Wolosker N, Cucato GG. A Single Bout of Arm-crank Exercise Promotes Positive Emotions and Post-Exercise Hypotension in Patients with Symptomatic Peripheral Artery Disease. Eur J Vasc Endovasc Surg. 2017 Feb;53(2):223-228. doi: 10.1016/j.ejvs.2016.11.021. Epub 2016 Dec 21.
PMID: 28012910
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
mesh term: Intermittent Claudication
sharing ipd: Yes
ipd description: We are planing to share our data in the future.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After publication of the main paper.
ipd access criteria: Ask to authors permision.