Exercise in Peripheral Artery Disease

Peripheral Artery Disease Clinical Trial

— GrEnADa  

Official title:

Exercise in Peripheral Artery Disease - Gender-specific Differences and Unexplored Opportunities in Women: the GrEnADa-project

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02878954
• Other study ID #: 13072016_Grenada
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2016
• Last updated: August 22, 2016
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: Katholieke Universiteit Leuven
• Contact: Veronique Cornelissen, PhD
• Phone: 003216329152
• Email: veronique.cornelissen[@]kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• No intervention (Observational study)
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.
• Control session
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.
• Exercise session
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	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.	No
Secondary	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.	Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.	No
Secondary	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.	Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.	No