Evaluation of the Effectiveness of Hybrid Cardiac Rehabilitation in Peripheral Artery Disease
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Biruni University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pain-Free Walking Distance
Overview
Brief 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.
Detailed Description
Peripheral artery disease (PAD) is a manifestation of systemic atherosclerosis and is associated with impaired lower extremity perfusion, intermittent claudication, reduced functional capacity, and diminished quality of life. Supervised exercise therapy (SET) is strongly recommended by international guidelines as a first-line treatment for symptomatic PAD, as it improves pain-free and maximal walking distance and delays the need for invasive interventions. Despite its proven effectiveness, participation in center-based SET programs remains suboptimal due to logistical, socioeconomic, and symptom-related barriers.
Hybrid cardiac rehabilitation (HCR) has emerged as a promising alternative model that integrates center-based supervised exercise with home-based and telerehabilitation-supported interventions. This approach aims to preserve the clinical benefits of supervised exercise while improving accessibility, flexibility, and long-term adherence.
This study is designed as a randomized controlled, single-blind trial to compare the clinical effectiveness of hybrid cardiac rehabilitation with conventional supervised exercise therapy in patients diagnosed with peripheral artery disease. Eligible participants aged 50-70 years with stable intermittent claudication (Fontaine stages I-II or Rutherford categories 1-3) will be randomly allocated to either the hybrid cardiac rehabilitation group or the supervised exercise therapy group.
Both groups will participate in a structured 12-week exercise program conducted three times per week. The supervised exercise therapy group will receive fully center-based, physiotherapist-supervised aerobic and strengthening exercises. The hybrid cardiac rehabilitation group will initially participate in center-based supervised sessions, followed by a home-based telerehabilitation phase supported by real-time or asynchronous remote monitoring. Exercise intensity and progression will be individualized based on perceived exertion, symptom tolerance, and functional assessments. Wearable activity tracking devices will be used to objectively monitor physical activity and adherence.
Outcome assessments will be performed at baseline and after completion of the intervention period. Primary outcome measures will include pain-free walking distance, maximal walking distance, and functional exercise capacity. Secondary outcomes will include exercise adherence, lower extremity muscle strength, walking tolerance, claudication pain severity, daily physical activity levels, and patient-reported outcomes related to quality of life and psychological well-being.
By directly comparing hybrid cardiac rehabilitation with supervised exercise therapy in a randomized controlled design, this study aims to address an important gap in the literature and to determine whether hybrid cardiac rehabilitation represents a feasible and effective alternative treatment strategy for patients with peripheral artery disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of peripheral artery disease with stable intermittent claudication.
- •Fontaine stage I-II or Rutherford category 1-
- •Age between 50 and 70 years.
- •Ability to walk independently without assistive devices.
- •Medically stable and eligible for exercise-based rehabilitation.
- •Willingness to participate in the study and to comply with the exercise program.
- •Provision of written informed consent prior to participation.
Exclusion Criteria
- •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.
- •Severe cognitive impairment or psychiatric conditions affecting compliance.
- •Participation in another structured exercise or rehabilitation program within the past 3 months.
- •Any medical condition deemed by the investigator to interfere with safe participation in the study.
Arms & Interventions
Hybrid Cardiac Rehabilitation Group
Participants will receive a hybrid cardiac rehabilitation program consisting of center-based supervised exercise sessions combined with home-based telerehabilitation-supported walking and strengthening exercises.
Intervention: Hybrid Cardiac Rehabilitation (Behavioral)
Supervised Exercise Therapy Group
Participants will receive conventional center-based supervised exercise therapy including treadmill walking and strengthening exercises under the supervision of a physiotherapist.
Intervention: Supervised Exercise Therapy (Behavioral)
Outcomes
Primary Outcomes
Pain-Free Walking Distance
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Muscle Strength(Baseline and Week 12)
- Walking Tolerance(Baseline and Week 12)
- Claudication Pain Severity(Baseline and Week 12)
- LDL Cholesterol (mg/dL)(Baseline and Week 12)
- HDL Cholesterol (mg/dL)(Baseline and Week 12)
- Total Cholesterol (mg/dL)(Baseline and Week 12)
- Triglycerides (mg/dL)(Baseline and Week 12)
- Fasting Plasma Glucose (mg/dL)(Baseline and Week 12)
- HbA1c (%)(Baseline and Week 12)
- Daily Physical Activity Level(Throughout the 12-week intervention period)
Investigators
Buket AKINCI
Prof. Dr.
Biruni University