Walking Training in Peripheral Artery Disease (GrEnADa Sub-study) (GrEnADa)
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|ClinicalTrials.gov Identifier: NCT02879019|
Recruitment Status : Not yet recruiting
First Posted : August 25, 2016
Last Update Posted : August 25, 2016
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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.
- 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 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.
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02879019
|Contact: Veronique Cornelissen, PhDfirstname.lastname@example.org|