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

KU Leuven

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Peripheral Artery Disease Intermittent Claudication

Interventions

Stretching exercise groupOTHER

In each stretching class, approximately 20 exercises will be performed. The total duration of the session will be approximately 30 minutes.

Walking training groupOTHER

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.

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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