High-intensity Intervals Versus Low-to-moderate-intensity Exercise Training in Patients Wi
Supervised exercise training (SET) is considered among first-line therapies for patients with symptomatic lower extremity peripheral artery disease (PAD), combined with general cardiovascular risk management, lifestyle adaptation and pharmacological treatment. Although without clear consistency, the guidelines give rec
| Condition(s) | Peripheral Arterial Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Supervised exercise training (SET) is considered among first-line therapies for patients with symptomatic lower extremity peripheral artery disease (PAD), combined with general cardiovascular risk management, lifestyle adaptation and pharmacological treatment. Although without clear consistency, the guidelines give recommendations in terms of claudication pain severity, SET volume, duration, and frequency. However, no or little guidance is offered as far as training intensity is concerned. Most of the previous studies on SET, in the context of PAD, did not distinguish between symptom intensity and common training intensity measures such as % of maximal heart rate (%HRmax), % of HR reserve (%HRR), % of peak oxygen uptake (%VO2peak), % of VO2 reserve (%VO2R), or the rate of perceived exertio |
| Who can participate | Inclusion Criteria: * Adult patients with symptomatic PAD (Fontaine stage IIa/b); * ABI ≤ 0.9 or drop by 20% following exercise treadmill test 1; * TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency); * Signed written informed consent form. Exclusion Criteria: * Age \< 18; * Unable to walk at 3.2 km/h on a treadmill (slope 0%) at least 300 m; * Previous participate in SET programs ≤ 1 year; * Prior leg/foot amputation; * Contraindication to exercise * Neurological and neuromuscular disorders and other comorbidities (orthopedic, rheumatologic) leading to gait abnormalities. * Known Pregnancy * Incapacity of discernment |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Centre Hospitalier Universitaire Vaudois |
| Locations | Lausanne, Canton of Vaud, Switzerland |
| Start date | 2023-03-01 |
| NCT ID | NCT05612945 |
| Official listing | https://clinicaltrials.gov/study/NCT05612945 |