Evaluation of the Effectiveness of Hybrid Cardiac Rehabilitation in Peripheral Artery Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Hybrid Cardiac Rehabilitation: The hybrid cardiac rehabilitation intervention consists of a structured exercise program combining center-based supervised treadmill walking sessions with home-based walking and strengthening exercises supported by telerehabilitation. Exercise intensity and progression are individualized based on perceived exertion and symptom tolerance. Participants are remotely monitored using wearable activity tracking devices and regular physiotherapist follow-up.

Supervised Exercise Therapy: Supervised exercise therapy consists of a center-based exercise program performed under the supervision of a physiotherapist. The program includes treadmill walking and strengthening exercises delivered according to established peripheral artery disease rehabilitation guidelines. Exercise intensity and progression are individualized based on perceived exertion, symptom tolerance, and functional capacity.

Study summary

Peripheral artery disease (PAD) is a common atherosclerotic condition characterized by reduced blood flow to the lower extremities, leading to intermittent claudication, decreased walking capacity, and impaired quality of life. Supervised exercise therapy is recommended as the first-line non-invasive treatment for patients with PAD; however, participation in center-based programs is often limited due to accessibility, time constraints, and symptom-related barriers.

This randomized controlled study aims to evaluate the clinical effectiveness of a hybrid cardiac rehabilitation program compared with conventional supervised exercise therapy in individuals diagnosed with peripheral artery disease. Participants will be randomly assigned to either a hybrid cardiac rehabilitation group or a supervised exercise therapy group.

The hybrid cardiac rehabilitation program will combine center-based supervised exercise sessions with home-based telerehabilitation, supported by remote monitoring and wearable activity tracking devices. The supervised exercise therapy group will receive a fully center-based, physiotherapist-supervised exercise program. Both interventions will be delivered over a 12-week period.

Primary outcomes will include walking performance and functional capacity. Secondary outcomes will assess exercise adherence, symptom severity, physical activity levels, and quality of life. The results of this study are expected to provide evidence on the feasibility and effectiveness of hybrid cardiac rehabilitation as an alternative rehabilitation model for patients with peripheral artery disease.

Eligibility

Primary outcome measure(s)

• Pain-Free Walking Distance — Baseline and Week 12
  Change in Pain-Free Walking Distance during constant-load treadmill test. Distance walked (meters) from the start of treadmill walking (3.2 km/h, 12% incline) until the onset of claudication pain.
• Maximal Walking Distance — Baseline and Week 12
  Total distance walked (meters) from the start of treadmill walking (3.2 km/h, 12% incline) until maximal tolerable claudication pain (Likert scale level 4).
• Functional Capacity — Baseline and Week 12
  Change in functional capacity will be assessed using the 6-Minute Walk Test (6MWT) performed according to the American Thoracic Society (ATS) guidelines (2002). The total distance walked (in meters) during the 6-minute test will be recorded. The test will be conducted in a 30-meter corridor, with standardized instructions and encouragement protocols.

Trial sites (1)

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