12 Weeks of Walking Exercise Training in Women With Peripheral Artery Disease: A Sub-study of GrEnADa-project
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- KU Leuven
- Primary Endpoint
- Change in heart rate pain threshold at 12 weeks of follow-up
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Investigators
Véronique Cornelissen
PhD
KU Leuven
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.
Outcomes
Primary Outcomes
Change in heart rate pain threshold at 12 weeks of follow-up
Time Frame: 12 weeks
The heart rate obtained at claudication onset distance during the treadmill test will be evaluate before and after 12 weeks of follow-up.
Change in walking capacity at 12 weeks of follow-up
Time Frame: 12 weeks
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.
Change in functional capacity at 12 weeks of follow-up
Time Frame: 12 weeks
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.
Secondary Outcomes
- Change in autonomic modulation at 12 weeks of follow-up(12 weeks)
- Change in vascular function at 12 weeks of follow-up(12 weeks)
- Change in cardiac output at 12 weeks of follow-up(12 weeks)
- Change in Ankle-Brachial Index decrease at 12 weeks of follow-up(12 weeks)
- Change in ischemic window at 12 weeks of follow-up(12 weeks)