Back to resultsWalking Training in Peripheral Artery Disease (GrEnADa Sub-study) (GrEnADa)
Primary Purpose
Peripheral Artery Disease, Intermittent Claudication
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stretching exercise group
Walking training group
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Stretching exercise group
Walking training group
Arm Description
Patients will receive two session per week of stretching classes.
Patients will perform two walking sessions per week.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Change in Ankle-Brachial Index decrease at 12 weeks of follow-up
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
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
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
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
Blood flow and blood flow in response to hyperemia will be obtained.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02879019
Brief Title
Walking Training in Peripheral Artery Disease (GrEnADa Sub-study)
Acronym
GrEnADa
Official Title
12 Weeks of Walking Exercise Training in Women With Peripheral Artery Disease: A Sub-study of GrEnADa-project
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not started due to lack of funding
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Intermittent Claudication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stretching exercise group
Arm Type
Sham Comparator
Arm Description
Patients will receive two session per week of stretching classes.
Arm Title
Walking training group
Arm Type
Experimental
Arm Description
Patients will perform two walking sessions per week.
Intervention Type
Other
Intervention Name(s)
Stretching exercise group
Intervention Description
In each stretching class, approximately 20 exercises will be performed. The total duration of the session will be approximately 30 minutes.
Intervention Type
Other
Intervention Name(s)
Walking training group
Intervention Description
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 Measure Information:
Title
Change in walking capacity at 12 weeks of follow-up
Description
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.
Time Frame
12 weeks
Title
Change in functional capacity at 12 weeks of follow-up
Description
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.
Time Frame
12 weeks
Title
Change in heart rate pain threshold at 12 weeks of follow-up
Description
The heart rate obtained at claudication onset distance during the treadmill test will be evaluate before and after 12 weeks of follow-up.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Ankle-Brachial Index decrease at 12 weeks of follow-up
Description
Will defined by the difference in ankle-brachial index measured immediately after the exercise and pre-exercise.
Time Frame
12 weeks
Title
Change in ischemic window at 12 weeks of follow-up
Description
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.
Time Frame
12 weeks
Title
Change in autonomic modulation at 12 weeks of follow-up
Description
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.
Time Frame
12 weeks
Title
Change in cardiac output at 12 weeks of follow-up
Description
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.
Time Frame
12 weeks
Title
Change in vascular function at 12 weeks of follow-up
Description
Blood flow and blood flow in response to hyperemia will be obtained.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Walking Training in Peripheral Artery Disease (GrEnADa Sub-study)
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