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

April 22, 2026 updated by: Buket AKINCI, Biruni University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 12
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).
Baseline and Week 12
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.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Strength
Time Frame: Baseline and Week 12
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
Walking Tolerance
Time Frame: Baseline and Week 12
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
Time Frame: Baseline and Week 12

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)
Time Frame: Baseline and Week 12
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)
Time Frame: Baseline and Week 12
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)
Time Frame: Baseline and Week 12
Total serum cholesterol will be assessed by enzymatic methods using a spectrophotometric autoanalyzer, reported in mg/dL.
Baseline and Week 12
Triglycerides (mg/dL)
Time Frame: Baseline and Week 12
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)
Time Frame: Baseline and Week 12
Fasting blood glucose levels (mg/dL) will be measured with hexokinase-based enzymatic methods at the hospital's laboratory.
Baseline and Week 12
HbA1c (%)
Time Frame: Baseline and Week 12
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
Time Frame: Throughout the 12-week intervention period
Daily physical activity level assessed using wearable activity monitoring devices. Steps per day measured using wearable activity monitor.
Throughout the 12-week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 16, 2026

Primary Completion (Estimated)

January 16, 2027

Study Completion (Estimated)

April 16, 2027

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-KAEK-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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