Back to resultsExercise in Peripheral Artery Disease (GrEnADa)
Primary Purpose
Peripheral Artery Disease, Intermittent Claudication
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
No intervention (Observational study)
Control session
Exercise session
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Ankle-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 3
Arm Type
Other
Other
Other
Arm Label
No intervention
Control session
Exercise session
Arm Description
160 men and women with PAD will be recruited.
40 patients (men and women) will complete this session.
40 patients (men and women) will complete this session.
Outcomes
Primary Outcome Measures
Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease.
After completion of the 6-minute walking test, patients will be asked to fill in the following questionnaires: walking impairment questionnaire, walking estimated-limitation calculated by history (WELCH), San Diego Claudication Questionnaire, SF-36 and two questionnaires for personal and environmental barriers to physical activity.
Gender-specific differences in walk capacity in patients with peripheral artery disease
The measurements of this outcome will be performed in a second visit day, separated by at least 48h from visit 1 (outcome 1).
Patients will perform a maximal exercise test to determine 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.
Gender-specific differences in functional capacity in patients with peripheral artery disease
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 obtained.
Secondary Outcome Measures
Gender-specific differences in physical activity level measured by accelerometer
Gender-specific differences in autonomic modulation at rest and after a maximal exercise test
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.
Gender-specific differences in vascular function in patients with peripheral artery disease at rest and after a maximal exercise test
Blood flow and blood flow response after reactive hyperemia.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02878954
Brief Title
Exercise in Peripheral Artery Disease
Acronym
GrEnADa
Official Title
Exercise in Peripheral Artery Disease - Gender-specific Differences and Unexplored Opportunities in Women: the GrEnADa-project
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives:
Objective 1: To identify gender-specific barriers towards exercise and physical activity in patients with peripheral artery disease (PAD).
Objective 2: To evaluate gender-specific differences in functional capacity and cardiovascular function and regulation in patients with PAD at rest, during and following a single session of maximal 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
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
Other
Arm Description
160 men and women with PAD will be recruited.
Arm Title
Control session
Arm Type
Other
Arm Description
40 patients (men and women) will complete this session.
Arm Title
Exercise session
Arm Type
Other
Arm Description
40 patients (men and women) will complete this session.
Intervention Type
Other
Intervention Name(s)
No intervention (Observational study)
Intervention Description
160 patients will be recruited to:
Fill in questionnaires related to demographic characteristics, severity of disease and physical activity.
Perform a six-minute walk test Comparison between men and women will be performed.
Intervention Type
Other
Intervention Name(s)
Control session
Intervention Description
Out of the 160 participants of the observational study, at least 40 (20 men and 20 women) will be recruited.
In the control session participants will be seated in resting position for 15 minutes.
Intervention Type
Other
Intervention Name(s)
Exercise session
Intervention Description
40 patients will perform a single maximal exercise test on a treadmill. Speed will be maintained at 3.2 km/h and the grade will be increased with 2% every 2 min following Gardner's protocol.
Primary Outcome Measure Information:
Title
Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease.
Description
After completion of the 6-minute walking test, patients will be asked to fill in the following questionnaires: walking impairment questionnaire, walking estimated-limitation calculated by history (WELCH), San Diego Claudication Questionnaire, SF-36 and two questionnaires for personal and environmental barriers to physical activity.
Time Frame
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Title
Gender-specific differences in walk capacity in patients with peripheral artery disease
Description
The measurements of this outcome will be performed in a second visit day, separated by at least 48h from visit 1 (outcome 1).
Patients will perform a maximal exercise test to determine 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.
Time Frame
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Title
Gender-specific differences in functional capacity in patients with peripheral artery disease
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 obtained.
Time Frame
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Secondary Outcome Measure Information:
Title
Gender-specific differences in physical activity level measured by accelerometer
Time Frame
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Title
Gender-specific differences in autonomic modulation at rest and after a maximal exercise test
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
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Title
Gender-specific differences in vascular function in patients with peripheral artery disease at rest and after a maximal exercise test
Description
Blood flow and blood flow response after reactive hyperemia.
Time Frame
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ankle-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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique Cornelissen, PhD
Phone
003216329152
Email
veronique.cornelissen@kuleuven.be
12. IPD Sharing Statement
Learn more about this trial
Exercise in Peripheral Artery Disease
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