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

NCT ID: NCT02879019

Last Updated: 2019-06-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2019-10-31

Brief Summary

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.

Conditions

Peripheral Artery Disease; Intermittent Claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stretching exercise group

Patients will receive two session per week of stretching classes.

Group Type: SHAM_COMPARATOR

Stretching exercise group

Intervention Type: OTHER

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

Walking training group

Patients will perform two walking sessions per week.

Group Type: EXPERIMENTAL

Walking training group

Intervention Type: OTHER

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.

Interventions

Stretching exercise group

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Véronique Cornelissen

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

150716_GrenSub

Identifier Type: -

Identifier Source: org_study_id