Walking Training in Peripheral Artery Disease (GrEnADa Sub-study)

Study Overview
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Brief Summary
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Whereas the efficacy of exercise interventions has been abundantly proven in male with peripheral artery disease (PAD), it remains to be determined whether these interventions are effective in women. The aim of this randomized controlled trial which will be performed with 34 PAD women will be to investigating the effects of 12 weeks of supervised walking on functional capacity and cardiovascular function and regulation at rest and during exercise.

Official Title
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12 Weeks of Walking Exercise Training in Women With Peripheral Artery Disease: A Sub-study of GrEnADa-project

Conditions
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Peripheral Artery Disease, Intermittent Claudication

Intervention / Treatment
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* Other: Stretching exercise group
* Other: Walking training group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aankle-brachial index (ABI) ≤ 0.9 in one or two legs fontaine stage II of PAD body mass index <35 kg/m2 resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg ability to walk at least 2min at 3.2 km/h ability to undertake an incremental treadmill test decrease of at least 15% in ABI after a maximal treadmill test not currently engaging in any regular exercise program Exclusion Criteria: exercise induced signs of myocardial ischemia or complex ventricular arrhythmias cardiovascular autonomic neuropathy use of beta-blocker, nondihydropyridine calcium antagonists or insulin and hormone replacement therapy.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Stretching exercise group<br>Patients will receive two session per week of stretching classes. | Other: Stretching exercise group<br>* In each stretching class, approximately 20 exercises will be performed. The total duration of the session will be approximately 30 minutes.<br>|
| Experimental: Walking training group<br>Patients will perform two walking sessions per week. | Other: Walking training group<br>* Patients will perform two walking session per week, each consisting of 15*2-min walking bouts, with 2-min of rest in between. The intensity will be set at heart rate corresponding to the pain threshold.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking capacity at 12 weeks of follow-up | Claudication onset distance (m) defined as the distance walked until the patients first reported pain in the leg during the treadmill test and total walk distance (m) defined as the total distance that the patient was able to walk during the test will be performed before and after 12 weeks of follow-up. | 12 weeks | 
| Change in functional capacity at 12 weeks of follow-up | Walking economy defined as VO2 measured during the first stage of the treadmill test and functional capacity defined as VO2 peak obtained during the test will be measured to determine the cardiopulmonary response after 12 weeks of walking training. | 12 weeks | 
| Change in heart rate pain threshold at 12 weeks of follow-up | The heart rate obtained at claudication onset distance during the treadmill test will be evaluate before and after 12 weeks of follow-up. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ankle-Brachial Index decrease at 12 weeks of follow-up | Will defined by the difference in ankle-brachial index measured immediately after the exercise and pre-exercise. | 12 weeks | 
| Change in ischemic window at 12 weeks of follow-up | Calculated by area under the curve of the ankle systolic blood pressure measured during the first 10 min of recovery after the test divided by total walk distance. | 12 weeks | 
| Change in autonomic modulation at 12 weeks of follow-up | Autonomic modulation: assessed by spectral analysis of heart rate and systolic blood pressure variabilities. Heart rate (electrocardiogram) and beat-by-beat blood pressure (finometer) will be recorded for 10 min at a sample frequency of 500Hz/channel. | 12 weeks | 
| Change in cardiac output at 12 weeks of follow-up | Cardiac output will be estimated at baseline and after 12 weeks of follow-up bu the indirect Fick method using the CO2 rebreathing technique and a metabolic card. | 12 weeks | 
| Change in vascular function at 12 weeks of follow-up | Blood flow and blood flow in response to hyperemia will be obtained. | 12 weeks |