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

NCT02879019 | Withdrawn

• 1 other identifier: 150716_GrenSub
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

• Change in autonomic modulation at 12 weeks of follow-up

  12 weeks

• Change in cardiac output at 12 weeks of follow-up

  12 weeks

• Change in vascular function at 12 weeks of follow-up

  12 weeks

Study Arms (2)

Stretching exercise group

SHAM COMPARATOR

Patients will receive two session per week of stretching classes.

Other: Stretching exercise group

Walking training group

EXPERIMENTAL

Patients will perform two walking sessions per week.

Other: Walking training group

Interventions

Stretching exercise group OTHER

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

Stretching exercise group

Walking training group 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.

Walking training group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 25, 2016
• Study Start: November 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 24, 2019

Record last verified: 2019-06