Cardiac Resynchronization Therapy Devices, Heart Failure, Implantable Cardioverter Defibrillator (ICD)
Conditions
Keywords
Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Device, Heart Failure, Upper Extremity Aerobic Exercise, Cardiac Rehabilitation, Physiotherapy and Rehabilitation
Brief 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. 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. 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.
Interventions
OTHERHigh-Intensity Interval Upper Extremity Aerobic Exercise Training
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
OTHERModerate Intensity Continuous Upper Extremity Aerobic Exercise Training
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
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
Sponsors
Erol Olcok Corum Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal arm exercise capacity | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral muscle strength | baseline and 8 weeks | 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. |
| Activities of Daily Living | baseline and 8 weeks | 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. |
| Health-related quality of life | baseline and 8 weeks | 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. |
| Disease-related quality of life | baseline and 8 weeks | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed