Peripheral Arterial DiseaseNCT07550959
Evaluation of the Effectiveness of Hybrid Cardiac Rehabilitation in Peripheral Artery Disease
A study testing Hybrid Cardiac Rehabilitation and Supervised Exercise Therapy in people with Peripheral Arterial Disease, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Hybrid Cardiac Rehabilitation and Supervised Exercise Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2026to 16 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Hybrid Cardiac Rehabilitation, Supervised Exercise Therapy
- Keywords
- peripheral arterial disease, Hybrid Cardiac Rehabilitation, Supervised Exercise Therapy, Telerehabilitation, Intermittent Claudication
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Cardiac RehabilitationBehavioural
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.
Supervised Exercise TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Supervised Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Baseline and Week 12
Secondary outcomes (10)
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.
Measured: Baseline and Week 12
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline and Week 12
HbA1c (%)
Glycated hemoglobin (HbA1c) will be measured using high-performance liquid chromatography (HPLC) and expressed as a percentage (%).
Measured: 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.
Measured: Throughout the 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start16 Sep 2026 (estimated)
- Primary completion16 Jan 2027 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550959
- Sponsor's protocol ID
- 2025-KAEK-49
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40742158Gornik 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.
PubMed 38743805Mazzolai 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.
PubMed 39210722
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Hybrid Cardiac Rehabilitation in Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT07550959
- Acronym / sponsor ID
- 2025-KAEK-49
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, Hybrid Cardiac Rehabilitation, Supervised Exercise Therapy, Telerehabilitation, Intermittent Claudication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 16 Jan 2027 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Cardiac Rehabilitation Group | Experimental | Behavioral: Hybrid Cardiac RehabilitationParticipants will receive a hybrid cardiac rehabilitation program consisting of center-based supervised exercise sessions combined with home-based telerehabilitation-supported walking and strengthening exercises. |
| Supervised Exercise Therapy Group | Active comparator | Behavioral: Supervised Exercise TherapyParticipants will receive conventional center-based supervised exercise therapy including treadmill walking and strengthening exercises under the supervision of a physiotherapist. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Cardiac RehabilitationThe 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. | Behavioural | Hybrid Cardiac Rehabilitation Group |
| Supervised Exercise TherapySupervised 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. | Behavioural | Supervised Exercise Therapy Group |
Primary outcome
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.
10 secondary outcomes
Muscle Strength
Time frame: Baseline and Week 12
Walking Tolerance
Time frame: Baseline and Week 12
Claudication Pain Severity
Time frame: Baseline and Week 12
LDL Cholesterol (mg/dL)
Time frame: Baseline and Week 12
HDL Cholesterol (mg/dL)
Time frame: Baseline and Week 12
Total Cholesterol (mg/dL)
Time frame: Baseline and Week 12
Triglycerides (mg/dL)
Time frame: Baseline and Week 12
Fasting Plasma Glucose (mg/dL)
Time frame: Baseline and Week 12
HbA1c (%)
Time frame: Baseline and Week 12
Daily Physical Activity Level
Time frame: Throughout the 12-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 40742158Scherrenberg 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.
- Background: PubMed 38743805Gornik 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.
- Background: PubMed 39210722Mazzolai 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Cardiac Rehabilitation and Supervised Exercise Therapy in people with Peripheral Arterial Disease, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duygu Yalçınkaya, MSc (+90 539 594 44 51, dyalcinkaya@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-Free Walking Distance (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07550959, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.