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

NCT07592494 | Not Yet Recruiting

• 1 other identifier: 2026-02
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.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.
3. 3.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; Cardiac Resynchronization Therapy Devices; Implantable Cardioverter Defibrillator (ICD)

Keywords

Implantable Cardioverter Defibrillator; Cardiac Resynchronization Therapy Device; Heart Failure; Upper Extremity Aerobic Exercise; Cardiac Rehabilitation; Physiotherapy and Rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  baseline and 8 weeks

Secondary Outcomes (4)

• Peripheral muscle strength

  baseline and 8 weeks

• Activities of Daily Living

  baseline and 8 weeks

• Health-related quality of life

  baseline and 8 weeks

• Disease-related quality of life

  baseline and 8 weeks

Study Arms (3)

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

Interventions

High-Intensity Interval Upper Extremity Aerobic Exercise Training OTHER

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

High-Intensity Interval Group

Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training OTHER

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

Moderate Intensity Continuous Group

Lower Extremity Aerobic Exercise Training OTHER

a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption

Control Group; High-Intensity Interval Group; Moderate Intensity Continuous Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Erol Olcok Corum Training and Research Hospital: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 18, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): May 11, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05