Exercise in Peripheral Artery Disease (GrEnADa)

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

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.

Study Overview

• Status: Unknown
• Conditions: Intermittent Claudication; Peripheral Artery Disease
• Intervention / Treatment: Other: No intervention (Observational study); Other: Control session; Other: Exercise session

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: No intervention; 160 men and women with PAD will be recruited.	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.; Other: 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.; Other: 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.
OTHER: Control session; 40 patients (men and women) will complete this session.	Other: 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.
OTHER: Exercise session; 40 patients (men and women) will complete this session.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.
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.

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (ESTIMATE): August 25, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: 13072016_Grenada