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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Cardiac Rehabilitation Group | Experimental | 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. |
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| Supervised Exercise Therapy Group | Active Comparator | Participants will receive conventional center-based supervised exercise therapy including treadmill walking and strengthening exercises under the supervision of a physiotherapist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Cardiac Rehabilitation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
| 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). | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duygu Yalçınkaya, MSc | Contact | +90 539 594 44 51 | dyalcinkaya@biruni.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biruni University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40742158 | Background | Scherrenberg M, Falter M, Abreu A, Aktaa S, Busnatu S, Casado-Arroyo R, Dendale P, Dilaveris P, Locati ET, Marques-Sule E, Neunhaeuserer D, Pedretti R, Perone F, Salzwedel A, Wilhelm M, Back M. Standards for cardiac telerehabilitation. Eur Heart J. 2025 Oct 7;46(38):3714-3737. doi: 10.1093/eurheartj/ehaf408. | |
| 38743805 | Background |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Participants will be randomly assigned to one of two parallel intervention groups: a hybrid cardiac rehabilitation group or a supervised exercise therapy group. Both groups will receive structured exercise interventions over the same study period and will be assessed at identical time points.
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| Supervised Exercise Therapy | Behavioral | 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. |
|
| 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| HDL Cholesterol (mg/dL) | Serum HDL cholesterol level will be measured using direct enzymatic colorimetric assay in mg/dL. Fasting samples collected by venipuncture. | Baseline and Week 12 |
| Total Cholesterol (mg/dL) | Total serum cholesterol will be assessed by enzymatic methods using a spectrophotometric autoanalyzer, reported in mg/dL. | Baseline and Week 12 |
| Triglycerides (mg/dL) | Triglyceride levels in fasting serum samples will be measured in mg/dL using standard enzymatic assays (GPO-PAP method). | Baseline and Week 12 |
| Fasting Plasma Glucose (mg/dL) | Fasting blood glucose levels (mg/dL) will be measured with hexokinase-based enzymatic methods at the hospital's laboratory. | Baseline and Week 12 |
| HbA1c (%) | Glycated hemoglobin (HbA1c) will be measured using high-performance liquid chromatography (HPLC) and expressed as a percentage (%). | Baseline and Week 12 |
| Daily Physical Activity Level | Daily physical activity level assessed using wearable activity monitoring devices. Steps per day measured using wearable activity monitor. | Throughout the 12-week intervention period |
| Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR; Peer Review Committee Members. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 11;149(24):e1313-e1410. doi: 10.1161/CIR.0000000000001251. Epub 2024 May 14. |
| 39210722 | Background | Mazzolai L, Teixido-Tura G, Lanzi S, Boc V, Bossone E, Brodmann M, Bura-Riviere A, De Backer J, Deglise S, Della Corte A, Heiss C, Kaluzna-Oleksy M, Kurpas D, McEniery CM, Mirault T, Pasquet AA, Pitcher A, Schaubroeck HAI, Schlager O, Sirnes PA, Sprynger MG, Stabile E, Steinbach F, Thielmann M, van Kimmenade RRJ, Venermo M, Rodriguez-Palomares JF; ESC Scientific Document Group. 2024 ESC Guidelines for the management of peripheral arterial and aortic diseases. Eur Heart J. 2024 Sep 29;45(36):3538-3700. doi: 10.1093/eurheartj/ehae179. No abstract available. |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |