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

Catholic University (KU) of Leuven

Status: Completed

Conditions: Peripheral Artery Disease; Intermittent Claudication

Treatments: Behavioral: aerobic+resistance exercise training program

Study type: Interventional

Funder types: Other

Identifiers

NCT04043546

PAD-feasibility

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Exercise intervention

Experimental group

Treatment:

Behavioral: aerobic+resistance exercise training program