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

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

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 Overview

• Status: Withdrawn
• Conditions: Intermittent Claudication; Peripheral Artery Disease
• Intervention / Treatment: Other: Stretching exercise group; Other: Walking training group

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Stretching exercise group; Patients will receive two session per week of stretching classes.	Other: Stretching exercise group; In each stretching class, approximately 20 exercises will be performed. The total duration of the session will be approximately 30 minutes.
Experimental: Walking training group; Patients will perform two walking sessions per week.	Other: Walking training group; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: 150716_GrenSub

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No