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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Pain-Free Walking Distance [Срок оценки: Baseline and Week 12]
• Maximal Walking Distance [Срок оценки: Baseline and Week 12]
• Functional Capacity [Срок оценки: Baseline and Week 12]

Вторичные конечные точки (10)

• Muscle Strength [Срок оценки: Baseline and Week 12]
• Walking Tolerance [Срок оценки: Baseline and Week 12]
• Claudication Pain Severity [Срок оценки: Baseline and Week 12]
• LDL Cholesterol (mg/dL) [Срок оценки: Baseline and Week 12]
• HDL Cholesterol (mg/dL) [Срок оценки: Baseline and Week 12]
• Total Cholesterol (mg/dL) [Срок оценки: Baseline and Week 12]
• Triglycerides (mg/dL) [Срок оценки: Baseline and Week 12]
• Fasting Plasma Glucose (mg/dL) [Срок оценки: Baseline and Week 12]
• HbA1c (%) [Срок оценки: Baseline and Week 12]
• Daily Physical Activity Level [Срок оценки: Throughout the 12-week intervention period]

Критерии участия

Критерии включения

• 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.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Biruni University — Istanbul

Публикации

• 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. PMID 40742158
• 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/ PMID 38743805
• 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 PMID 39210722

Идентификаторы

NCT: NCT07550959 · 2025-KAEK-49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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