NCT04043546
Completed
N/A
Observational Feasability Study of Home-based Training With Therabands in PAD-patients - Addressing the Uncertainty of Acceptance, Satisfaction and Usability of a Home-based, Tele-monitored Program Combining Aerobic and Resistance Components in PAD-patients.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- KU Leuven
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- user satisfaction
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The study is an observational feasibility study to evaluate the feasibility of a combined aerobic+resistance training program in patients with IC.
Investigators
Roselien Buys
Principal Investigator
KU Leuven
Eligibility Criteria
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
Outcomes
Primary Outcomes
user satisfaction
Time Frame: 4 weeks
self-developed questionnaire based evaluation of user satisfaction
walking distance
Time Frame: 4 weeks
pain free and maximal walking distance are recorded using the Gardner treadmill protocol.
Secondary Outcomes
- Physical activity(2 months)
Study Sites (1)
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