Exercise in Peripheral Artery Disease (GrEnADa)

C

Catholic University (KU) of Leuven

Status

Unknown

Conditions

Peripheral Artery Disease
Intermittent Claudication

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02878954
13072016_Grenada

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

160 participants in 3 patient groups

No intervention
Other group
Description:
160 men and women with PAD will be recruited.
Treatment:
Other: No intervention (Observational study)
Other: Exercise session
Other: Control session
Control session
Other group
Description:
40 patients (men and women) will complete this session.
Treatment:
Other: Control session
Exercise session
Other group
Description:
40 patients (men and women) will complete this session.
Treatment:
Other: Exercise session

Trial contacts and locations

0

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Central trial contact

Veronique Cornelissen, PhD

Data sourced from clinicaltrials.gov

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