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

NCT07550959 | Not Yet Recruiting

• 1 other identifier: 2025-KAEK-49
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease; Hybrid Cardiac Rehabilitation; Supervised Exercise Therapy; Telerehabilitation; Intermittent Claudication

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• 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

Study Arms (2)

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.

Behavioral: Hybrid Cardiac Rehabilitation

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.

Behavioral: Supervised Exercise Therapy

Interventions

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.

Hybrid Cardiac Rehabilitation Group

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.

Supervised Exercise Therapy Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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.

  PMID: 38743805 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.

  PMID: 39210722 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Duygu Yalçınkaya, MSc

CONTACT

+90 539 594 44 51; dyalcinkaya@biruni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): September 16, 2026
• Primary Completion (Estimated): January 16, 2027
• Study Completion (Estimated): April 16, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

TU (1)