Heart FailureNCT07592494
Comparison of the Effects of Different Upper Extremity Aerobic Exercise Training Protocols on Arm Functional Capacity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
A study testing High-Intensity Interval Upper Extremity Aerobic Exercise Training, Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training and Lower Extremity Aerobic Exercise Training in people with Heart Failure and Implantable Cardioverter Defibrillator (ICD), run by Erol Olcok Corum Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
1. To determine the most suitable exercise protocol for upper extremity aerobic exercise training, a widely used type of aerobic exercise to improve reduced upper extremity functional capacity in individuals with CIED and HF. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy Devices
- What is being tested?
- High-Intensity Interval Upper Extremity Aerobic Exercise Training, Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training and Lower Extremity Aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2026to 11 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over with heart failure who are receiving Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)
- At least 3 months have passed since device implantation and there have been no complications at the last device control
- Being in New York Heart Association (NYHA) Class II-III
- Patients without cooperation problems
- Patients who volunteer to participate in the study
Who cannot join
- Patients who have previously participated in a cardiac rehabilitation program and those who have completed less than 1 year since the program,
- Patients with a primary diagnosis of cardiomyopathy and those with heart failure secondary to cardiomyopathy,
- Patients with a history of shoulder pathologies that may restrict upper extremity movement before device implantation (such as severe pain around the shoulder, edema, or shoulder dislocation that restricts upper extremity movement),
- Patients with a history of shoulder surgery (patients with limitations in range of motion),
- Patients who have undergone mastectomy on the affected side or a cerebrovascular event resulting in arm involvement,
- Patients with decompensated heart failure,
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- Patients with a history of ICD-incompatible shock,
- Patients with a history of unstable angina pectoris, acute myocardial infarction, or cardiac surgery within the last 3 months,
- Patients who have experienced acute atrial fibrillation, ventricular tachycardia, and ventricular fibrillation within the last 3 months,
- Patients with actively treated malignancy or collagen tissue disease receiving systemic steroids
- Patients with chronic kidney disease undergoing dialysis where volume load is unstable,
- Persistent ventricular arrhythmias during baseline cardiopulmonary exercise testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit
Çorum
Gamze Nur Ahiskali, 905514128687, gmzahiskali@gmail.com
About this study
- To determine the most suitable exercise protocol for upper extremity aerobic exercise training, a widely used type of aerobic exercise to improve reduced upper extremity functional capacity in individuals with CIED and HF.
- To investigate whether high-intensity intermittent upper extremity aerobic exercise training provides a more effective improvement in upper extremity functional capacity compared to moderate-intensity continuous upper extremity aerobic exercise training.
- To determine the effectiveness of different types of upper extremity aerobic exercise training compared to lower extremity aerobic training alone in individuals with CIED and HF.
- Conditions
- Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy Devices
- Being tested
- High-Intensity Interval Upper Extremity Aerobic Exercise Training, Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training, Lower Extremity Aerobic Exercise Training
- Keywords
- Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Device, Heart Failure, Upper Extremity Aerobic Exercise, Cardiac Rehabilitation, Physiotherapy and Rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Upper Extremity Aerobic Exercise TrainingOther
total of 20 minutes, consisting of 5 minutes of warm-up, 3x2 minutes of high-intensity training at 80-90% of maximum workload, 2x2 minutes of active rest at 30-40% of maximum workload, and 5 minutes of cool-down
Moderate Intensity Continuous Upper Extremity Aerobic Exercise TrainingOther
a total of 20 minutes, consisting of 5 minutes of warm-up, 10 minutes at 70-80% of maximum workload, and 5 minutes of cool-down
Lower Extremity Aerobic Exercise TrainingOther
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Group | Experimental | Not described Receives: Other: High-Intensity Interval Upper Extremity Aerobic Exercise Training; Other: Lower Extremity Aerobic Exercise Training |
| Moderate Intensity Continuous Group | Experimental | Not described Receives: Other: Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training; Other: Lower Extremity Aerobic Exercise Training |
| Control Group | Active comparator | Not described Receives: Other: Lower Extremity Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal arm exercise capacity
The outcome will be evaluated using an arm ergometer exercise test. The test will begin with a 3-minute (unloaded) warm-up after rest. Different protocols will be applied to male and female patients due to differences in strength capabilities. Men will start rotating the ergometer with a 30-W workload, while women will start with a 20-W workload. In both protocols, patients will be asked to maintain a rotation speed of 70 revolutions per minute (rpm) throughout the test. Again, due to their different strength levels, the workload will be increased by 10W for men and 6W for women every minute.
Measured: baseline and 8 weeks
Functional arm exercise capacity
The outcome will be evaluated using the 6 Minute Pegboard and Ring Test (6PBRT). During the 6PBRT, participants are asked to move rings on a pegboard from the two lower holes to the two upper holes using both arms simultaneously for 6 minutes. Standardized encouragement is given every minute during the test. The number of rings moved over 6 minutes gives the total score of the test.
Measured: baseline and 8 weeks
Cardiorespiratory Fitness
The Maximum Symptom-Limited Cardiopulmonary Exercise Test (CPET), the gold standard method for assessing cardiorespiratory fitness, will be performed on a bicycle ergometer (Corival CPET, Lode, Groningen, Netherlands). During the test, the bicycle ergometer ramp test protocol will be applied (starting workload = 20 W / 20W increase every three minutes / maintaining a rotation speed of 60-70 rpm) (2). During the CPET, heart rate (HR) and heart rhythm will be continuously monitored with a 12-channel ECG test system (Custo Cardio 200 BT system, CustoMed GmbH, Ottoburn, Germany).
Measured: baseline and 8 weeks
Secondary outcomes (4)
Peripheral muscle strength
The outcome will be measured using a hand dynamometer (Baseline Hydraulic Hand Dynamometer, Model: 12-0240, Fabrication Enterprises INC. White Plains, NY 10602 U.S.A.). Measurements will be taken in a seated position with shoulder adduction, elbow 90° flexion, and forearm in neutral position. Three repetitions will be performed for each side. The averages for the right and left sides will be recorded for statistical analysis.
Measured: baseline and 8 weeks
Activities of Daily Living
The outcome will be assessed using the Performance Measure for Activities of Daily Living-8 for Patients with Mild Symptomatic Heart Failure (PMADL-8). PMADL-8, an ICF-based scale, has a total score ranging from 8 to 32, and a high score indicates the level of limitation in activities of daily living.
Measured: baseline and 8 weeks
Health-related quality of life
MacNew Heart Disease Health-Related Quality of Life Questionnaire The questionnaire consists of three sub-dimensions and 27 items: a physical limitation scale, an emotional limitation scale, and a social functioning scale, with some items falling into more than one sub-dimension. Questions are scored between 1 and 7. The total score of the questionnaire is calculated by averaging the scores given to the sub-dimensions. Higher scores indicate better quality of life.
Measured: baseline and 8 weeks
Disease-related quality of life
Assessment of Quality of Life and Related Events Scale (AQUAREL) Developed specifically for patients with pacemakers, the scale consists of 5 main sections: chest pain, arrhythmia, dyspnea, exertion, and cognition. The scale consists of 24 questions scored using a 5-point Likert system. The total score ranges from 0 to 100. A low score reflects a perception of poor health, loss of function, and the presence of pain, while a high score reflects a perception of good health, preserved function, and the absence of pain.
Measured: baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start11 May 2026
- Primary completion11 May 2027 (estimated)
- Study completion11 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erol Olcok Corum Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Nur AHISKALI, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592494
- Sponsor's protocol ID
- 2026-02
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Upper Extremity Aerobic Exercise Training Protocols on Arm Functional Capacity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
- ClinicalTrials.gov ID
- NCT07592494
- Acronym / sponsor ID
- 2026-02
- Conditions
- Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy Devices
- Keywords
- Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Device, Heart Failure, Upper Extremity Aerobic Exercise, Cardiac Rehabilitation, Physiotherapy and Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Erol Olcok Corum Training and Research HospitalUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- 11 May 2027 (estimated)
- Study completion
- 11 May 2027 (estimated)
- First posted
- 18 May 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.
- To determine the most suitable exercise protocol for upper extremity aerobic exercise training, a widely used type of aerobic exercise to improve reduced upper extremity functional capacity in individuals with CIED and HF.
- To investigate whether high-intensity intermittent upper extremity aerobic exercise training provides a more effective improvement in upper extremity functional capacity compared to moderate-intensity continuous upper extremity aerobic exercise training.
- To determine the effectiveness of different types of upper extremity aerobic exercise training compared to lower extremity aerobic training alone in individuals with CIED and HF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Group | Experimental | Other: High-Intensity Interval Upper Extremity Aerobic Exercise Training, Other: Lower Extremity Aerobic Exercise Training |
| Moderate Intensity Continuous Group | Experimental | Other: Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training, Other: Lower Extremity Aerobic Exercise Training |
| Control Group | Active comparator | Other: Lower Extremity Aerobic Exercise Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 and over with heart failure who are receiving Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)
- At least 3 months have passed since device implantation and there have been no complications at the last device control
- Being in New York Heart Association (NYHA) Class II-III
- Patients without cooperation problems
- Patients who volunteer to participate in the study
Key exclusion criteria (12 listed)
- Patients who have previously participated in a cardiac rehabilitation program and those who have completed less than 1 year since the program,
- Patients with a primary diagnosis of cardiomyopathy and those with heart failure secondary to cardiomyopathy,
- Patients with a history of shoulder pathologies that may restrict upper extremity movement before device implantation (such as severe pain around the shoulder, edema, or shoulder dislocation that restricts upper extremity movement),
- Patients with a history of shoulder surgery (patients with limitations in range of motion),
- Patients who have undergone mastectomy on the affected side or a cerebrovascular event resulting in arm involvement,
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 |
|---|---|---|
| High-Intensity Interval Upper Extremity Aerobic Exercise Trainingtotal of 20 minutes, consisting of 5 minutes of warm-up, 3x2 minutes of high-intensity training at 80-90% of maximum workload, 2x2 minutes of active rest at 30-40% of maximum workload, and 5 minutes of cool-down | Other | High-Intensity Interval Group |
| Moderate Intensity Continuous Upper Extremity Aerobic Exercise Traininga total of 20 minutes, consisting of 5 minutes of warm-up, 10 minutes at 70-80% of maximum workload, and 5 minutes of cool-down | Other | Moderate Intensity Continuous Group |
| Lower Extremity Aerobic Exercise Traininga total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption | Other | Control Group, High-Intensity Interval Group, Moderate Intensity Continuous Group |
Primary outcome
Maximal arm exercise capacity
Time frame: baseline and 8 weeks
The outcome will be evaluated using an arm ergometer exercise test. The test will begin with a 3-minute (unloaded) warm-up after rest. Different protocols will be applied to male and female patients due to differences in strength capabilities. Men will start rotating the ergometer with a 30-W workload, while women will start with a 20-W workload. In both protocols, patients will be asked to maintain a rotation speed of 70 revolutions per minute (rpm) throughout the test. Again, due to their different strength levels, the workload will be increased by 10W for men and 6W for women every minute.
Functional arm exercise capacity
Time frame: baseline and 8 weeks
The outcome will be evaluated using the 6 Minute Pegboard and Ring Test (6PBRT). During the 6PBRT, participants are asked to move rings on a pegboard from the two lower holes to the two upper holes using both arms simultaneously for 6 minutes. Standardized encouragement is given every minute during the test. The number of rings moved over 6 minutes gives the total score of the test.
Cardiorespiratory Fitness
Time frame: baseline and 8 weeks
The Maximum Symptom-Limited Cardiopulmonary Exercise Test (CPET), the gold standard method for assessing cardiorespiratory fitness, will be performed on a bicycle ergometer (Corival CPET, Lode, Groningen, Netherlands). During the test, the bicycle ergometer ramp test protocol will be applied (starting workload = 20 W / 20W increase every three minutes / maintaining a rotation speed of 60-70 rpm) (2). During the CPET, heart rate (HR) and heart rhythm will be continuously monitored with a 12-channel ECG test system (Custo Cardio 200 BT system, CustoMed GmbH, Ottoburn, Germany).
4 secondary outcomes
Peripheral muscle strength
Time frame: baseline and 8 weeks
Activities of Daily Living
Time frame: baseline and 8 weeks
Health-related quality of life
Time frame: baseline and 8 weeks
Disease-related quality of life
Time frame: baseline and 8 weeks
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 31 Jul 2026.
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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.
Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit
Çorum, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Interval Upper Extremity Aerobic Exercise Training, Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training and Lower Extremity Aerobic Exercise Training in people with Heart Failure and Implantable Cardioverter Defibrillator (ICD), run by Erol Olcok Corum Training and Research Hospital 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 31 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal arm exercise capacity (time frame: baseline and 8 weeks). 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?
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 31 Jul 2026.