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Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease

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ClinicalTrials.gov Identifier: NCT03837639
Recruitment Status : Suspended (The study was suspended indefinitely because of Covid-19.)
First Posted : February 12, 2019
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
University of Nove de Julho
Northumbria University
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

Tracking Information
First Submitted Date  ICMJE February 7, 2019
First Posted Date  ICMJE February 12, 2019
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date December 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
ambulatory blood pressure [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
ambulatory blood pressure [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2020)
  • Clinic blood pressure [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
    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).
  • Central blood pressure [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
    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).
  • Heart rate variability [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
    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).
  • Arterial stiffness [ Time Frame: Change from baseline in arterial stiffness at 12 weeks ]
    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).
  • Vascular function [ Time Frame: Change from baseline in flow-mediated vasodilation at 12 weeks ]
    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).
  • Walking capacity [ Time Frame: Change from baseline in walking distance at 12 weeks ]
    Six-minute walking test will be measured before and after 12 weeks of intervention
  • March in place [ Time Frame: Change from baseline in the number of the steps at 12 weeks ]
    Two-minute step test will be measured before and after 12 weeks of intervention
  • Subjective measurement of walking capacity [ Time Frame: Change from baseline in the walking impairment questionnaire score after 12 weeks ]
    Walking impairment questionnaire will be measured before and after 12 weeks of intervention
  • 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 ]
    Walking estimated limitation calculated by history questionnaire will be measured before and after 12 weeks of intervention
  • Overall strength test [ Time Frame: Change from baseline in kgf of the handgrip test after 12 weeks ]
    Handgrip strength test will be measured before and after 12 weeks of intervention
  • Symptoms of intermittent claudication [ Time Frame: Change from baseline in the Baltimore Activity Scale for Intermittent Claudication score after 12 weeks ]
    The Baltimore Activity Scale for Intermittent Claudication is a questionnaire that will be measured before and after 12 weeks of intervention.
  • General functional capacity [ Time Frame: Change from baseline in the Short Physical Performance Battery score after 12 weeks ]
    The Short Physical Performance Battery will be measured before and after 12 weeks of intervention.
  • Specific quality of life of vascular patients [ Time Frame: Change from baseline in the Vascular quality of life questionnaire score after 12 weeks ]
    The Vascular quality of life questionnaire will be measured before and after 12 weeks of intervention.
  • General quality of life [ Time Frame: Change from baseline in the World Health Organization Quality of Life score after 12 weeks ]
    The World Health Organization Quality of Life questionnaire will be measured before and after 12 weeks of intervention
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2019)
  • Clinical blood pressure [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
    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).
  • Cardiac autonomic modulation [ Time Frame: Change from baseline in ambulatory blood pressure at 12 weeks ]
    Cardiac autonomic modulation will be measured before and after 12 weeks of intervention period on intervention and control group by heart rate monitor (Polar, RS 800, USA).
  • Arterial stiffness [ Time Frame: Change from baseline in arterial stiffness at 12 weeks ]
    Arterial stiffness 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).
  • Vasodilatory capacity [ Time Frame: Change from baseline in flow-mediated vasodilation at 12 weeks ]
    Vasodilatory capacity will be measured before and after e12 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease
Official Title  ICMJE Effects of Arm-crank Exercise Training on Cardiovascular Function of Patients With Peripheral Artery Disease: a Randomized Controlled Trial
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Arterial Disease
  • Intermittent Claudication
  • Hypertension
Intervention  ICMJE
  • Other: Arm ergometer
    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
  • Other: Treadmill ergometer
    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.
  • Other: Control group
    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.
Study Arms  ICMJE
  • Experimental: Arm crank ergometer
    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.
    Intervention: Other: Arm ergometer
  • Experimental: Treadmill ergometer
    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.
    Intervention: Other: Treadmill ergometer
  • Control group
    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: Other: Control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 8, 2019)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 10, 2021
Estimated Primary Completion Date December 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • PAD stage II
  • Ankle brachial index <0.90 in one or both lower limbs;
  • Women in post-menopause phase without hormone replacement therapy
  • Not an active smoker;
  • Able to perform exercise training;

Patients selected to participate in the study will be only excluded if:

  • Change their medication;
  • Present any health impairment that contraindicates the practice of physical exercise during the study;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03837639
Other Study ID Numbers  ICMJE PAD01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We are planing to share our data in the future.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After publication of the main paper.
Access Criteria: Ask to authors permision.
Responsible Party Hospital Israelita Albert Einstein
Study Sponsor  ICMJE Hospital Israelita Albert Einstein
Collaborators  ICMJE
  • University of Nove de Julho
  • Northumbria University
Investigators  ICMJE Not Provided
PRS Account Hospital Israelita Albert Einstein
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP