Exercise in Peripheral Artery Disease
GrEnADa
1 other identifier
interventional
160
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2016
CompletedFirst Posted
Study publicly available on registry
August 25, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 25, 2016
August 1, 2016
2.7 years
August 11, 2016
August 22, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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.
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
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.
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
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.
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Secondary Outcomes (3)
Gender-specific differences in physical activity level measured by accelerometer
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in autonomic modulation at rest and after a maximal exercise test
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in vascular function in patients with peripheral artery disease at rest and after a maximal exercise test
Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Study Arms (3)
No intervention
OTHER160 men and women with PAD will be recruited.
Control session
OTHER40 patients (men and women) will complete this session.
Exercise session
OTHER40 patients (men and women) will complete this session.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
January 1, 2017
Primary Completion
September 1, 2019
Study Completion
December 1, 2019
Last Updated
August 25, 2016
Record last verified: 2016-08