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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02879019
Recruitment Status : Not yet recruiting
First Posted : August 25, 2016
Last Update Posted : August 25, 2016
Information provided by (Responsible Party):
Véronique Cornelissen, KU Leuven

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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Intermittent Claudication Other: Stretching exercise group Other: Walking training group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 12 Weeks of Walking Exercise Training in Women With Peripheral Artery Disease: A Sub-study of GrEnADa-project
Study Start Date : January 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. Change in Ankle-Brachial Index decrease at 12 weeks of follow-up [ Time Frame: 12 weeks ]
    Will defined by the difference in ankle-brachial index measured immediately after the exercise and pre-exercise.

  2. Change in ischemic window at 12 weeks of follow-up [ Time Frame: 12 weeks ]
    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.

  3. Change in autonomic modulation at 12 weeks of follow-up [ Time Frame: 12 weeks ]
    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.

  4. Change in cardiac output at 12 weeks of follow-up [ Time Frame: 12 weeks ]
    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.

  5. Change in vascular function at 12 weeks of follow-up [ Time Frame: 12 weeks ]
    Blood flow and blood flow in response to hyperemia will be obtained.

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02879019

Contact: Veronique Cornelissen, PhD 003216329152

Sponsors and Collaborators
KU Leuven

Responsible Party: Véronique Cornelissen, PhD, KU Leuven Identifier: NCT02879019     History of Changes
Other Study ID Numbers: 150716_GrenSub
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Peripheral Arterial Disease
Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms