Observational Feasibility Study of Home-based Training With Therabands in PAD-patients

Not Applicable

Completed

• Conditions: Peripheral Artery Disease; Intermittent Claudication
• Interventions: Behavioral: aerobic+resistance exercise training program

• Registration Number: NCT04043546
• Lead Sponsor: KU Leuven

Brief Summary

The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-07-10
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-01
• Last Update Submitted: 2019-08-01
• Study First Posted: 2019-08-02
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• age ≥ 50 yrs;
• ankle-brachial index (ABI) ≤ 0.9 in one or two legs;
• Fontaine stage II (Rutherford I 1-3) of PAD (new onset or conservatively treated);
• body mass index <35 kg/m 2 ;
• resting systolic blood pressure (BP) <160 mmHg and diastolic BP <105 mmHg;
• ability to walk at least 2 min at 2.0 mph;
• 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;
• no access to laptop or internet;
• no medical clearance for exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise intervention	aerobic+resistance exercise training program	-

Primary Outcome Measures

Name	Time	Method
user satisfaction	4 weeks	self-developed questionnaire based evaluation of user satisfaction
walking distance	4 weeks	pain free and maximal walking distance are recorded using the Gardner treadmill protocol.

Secondary Outcome Measures

Name	Time	Method
Physical activity	2 months	Physical activity, defined total active energy expenditure (kcal) is obtained from objective measurement of physical activity during 7 consecutive days using the Sensewear device.

Trial Locations

Locations (1)

KU Leuven; 🇧🇪 Leuven, Belgium