Exercise in Peripheral Artery Disease

Not Applicable

• Conditions: Peripheral Artery Disease; Intermittent Claudication
• Interventions: Other: Exercise session; Other: No intervention (Observational study); Other: Control session

• Registration Number: NCT02878954
• Lead Sponsor: KU Leuven

Brief Summary

This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives:

Objective 1: To identify gender-specific barriers towards exercise and physical activity in patients with peripheral artery disease (PAD).

Objective 2: To evaluate gender-specific differences in functional capacity and cardiovascular function and regulation in patients with PAD at rest, during and following a single session of maximal exercise.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-22
• Last Update Submitted: 2016-08-22
• Study First Posted: 2016-08-25
• Last Update Posted: 2016-08-25
• Study Start: 2017-01
• Primary Completion: 2019-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Ankle-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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise session	Exercise session	40 patients (men and women) will complete this session.
No intervention	No intervention (Observational study)	160 men and women with PAD will be recruited.
No intervention	Control session	160 men and women with PAD will be recruited.
No intervention	Exercise session	160 men and women with PAD will be recruited.
Control session	Control session	40 patients (men and women) will complete this session.

Primary Outcome Measures

Name	Time	Method
Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease.	Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.	After completion of the 6-minute walking test, patients will be asked to fill in the following questionnaires: walking impairment questionnaire, walking estimated-limitation calculated by history (WELCH), San Diego Claudication Questionnaire, SF-36 and two questionnaires for personal and environmental barriers to physical activity.
Gender-specific differences in walk capacity in patients with peripheral artery disease	Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.	The measurements of this outcome will be performed in a second visit day, separated by at least 48h from visit 1 (outcome 1).; Patients will perform a maximal exercise test to determine 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.
Gender-specific differences in functional capacity in patients with peripheral artery disease	Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.	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 obtained.

Secondary Outcome Measures

Name	Time	Method
Gender-specific differences in vascular function in patients with peripheral artery disease at rest and after a maximal exercise test	Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.	Blood flow and blood flow response after reactive hyperemia.
Gender-specific differences in autonomic modulation at rest and after a maximal exercise test	Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.	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.
Gender-specific differences in physical activity level measured by accelerometer	Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.