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
2026년 7월 29일 업데이트: Gamze Nur AHISKALI, Erol Olcok Corum Training and Research Hospital
- 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.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
36
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Çorum, 터키 (Türkiye)
- 모병
- Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit
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연락하다:
- Gamze Nur Ahiskali
- 전화번호: 905514128687
- 이메일: gmzahiskali@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 대조군
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a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
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실험적: High-Intensity Interval Group
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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
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
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실험적: Moderate Intensity Continuous Group
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a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Maximal arm exercise capacity
기간: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Functional arm exercise capacity
기간: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Cardiorespiratory Fitness
기간: baseline and 8 weeks
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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).
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baseline and 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Peripheral muscle strength
기간: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Activities of Daily Living
기간: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Health-related quality of life
기간: baseline and 8 weeks
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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.
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baseline and 8 weeks
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Disease-related quality of life
기간: baseline and 8 weeks
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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.
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baseline and 8 weeks
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 5월 11일
기본 완료 (추정된)
2027년 5월 11일
연구 완료 (추정된)
2027년 5월 11일
연구 등록 날짜
최초 제출
2026년 5월 5일
QC 기준을 충족하는 최초 제출
2026년 5월 11일
처음 게시됨 (실제)
2026년 5월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 31일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 29일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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기타 연구 ID 번호
- 2026-02
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