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.
Diagnosis of peripheral artery disease with stable intermittent claudication.
Fontaine stage I-II or Rutherford category 1-3.
Age between 50 and 70 years.
Ability to walk independently without assistive devices.
Critical limb ischemia or rest pain.
Recent lower extremity revascularization or major surgery within the past 6 months.
Unstable cardiovascular conditions (e.g., unstable angina, uncontrolled arrhythmias).
Severe pulmonary, neurological, or musculoskeletal disorders limiting exercise participation.
Parallel
Hybrid Cardiac Rehabilitation
BehavioralThe 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
BehavioralSupervised 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.
Pain-Free Walking Distance
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
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
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.
Muscle Strength
Lower extremity muscle strength, balance, and functional mobility assessed using the Short Physical Performance Battery (SPPB), which includes a 4-meter gait speed test, chair stand test, and standing balance test. Each component is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate better lower extremity physical performance.
Walking Tolerance
Walking tolerance will be assess with Walking Impairment Questionnaire (WIQ) total score. Self-reported walking limitation assessed using WIQ (score 0-100). The higher scores indicating better walking ability.
Claudication Pain Severity
Severity of claudication pain will be assessed using a 5-point Likert-type pain scale developed specifically for intermittent claudication, rated by the patient. The scale ranges from 0 (no pain) to 4 (maximum pain - unable to continue walking). Patients will be instructed to rate their worst pain during walking on this scale. Higher scores indicate worse pain severity.
LDL Cholesterol (mg/dL)
Serum LDL cholesterol concentration will be measured in mg/dL at baseline and week 12 using standard enzymatic colorimetric methods performed at the hospital's central biochemistry laboratory. Fasting blood samples (≥8 hours) will be used.
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