Blood Flow Restriction Combined With Aerobic or Resistance Exercise in Heart Failure
2026년 5월 31일 업데이트: FATMA DİLARA AKAR ÇAMYAR, Biruni University
Comparison of the Effects of Aerobic or Resistance Exercises Combined With Blood Flow Restriction on Muscle Oxygenation, Serum BNP Levels, Functional Capacity, and Quality of Life in Patients With Heart Failure
The aim of this study is to compare the clinical effects of aerobic and resistance exercise modalities combined with blood flow restriction in patients with stable heart failure, and to determine the most effective, feasible, and evidence-based rehabilitation approach.
In individuals with heart failure, limited exercise tolerance increases the importance of training strategies that can induce high physiological adaptations with low mechanical loads.
In this context, exercise interventions combined with blood flow restriction have attracted increasing attention due to their low-intensity nature and potential clinical benefits.
This study is designed as a prospective, parallel-group, randomized controlled clinical trial to be conducted in 40 patients diagnosed with stable heart failure.
Participants will be randomized into two groups: a blood flow restriction- combined aerobic exercise group and a blood flow restriction-combined resistance exercise group, both applied under supervision three times per week for eight weeks.
All participants will be assessed before and after the intervention in terms of muscle oxygenation, serum B-type natriuretic peptide (BNP) levels, functional capacity, and quality of life.
The expected outcome of this study is to obtain comparative data on the clinical effectiveness of blood flow restriction- combined exercise interventions in patients with stable heart failure and to identify which exercise modality provides superior clinical benefits.
The findings are anticipated to contribute to the development of short-term, low-cost rehabilitation protocols and to provide evidence-based guidance for clinical practice.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Dilara AKAR ÇAMYAR, Principal Investigator
- 전화번호: +905393291126
- 이메일: f.dilaraakar@gmail.com
연구 장소
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Zeytinburnu
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Istanbul, Zeytinburnu, 터키 (Türkiye), 34015
- Biruni University
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연락하다:
- Biruni University
- 전화번호: +90 444 8 276
- 이메일: info@biruni.edu.tr
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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:
- NYHA functional class I-III,
- HFrEF and/or HFmrEF with left ventricular ejection fraction <50%,
- functional capacity that does not prevent participation in exercise, and
- clinical stability within the last 3 months.
Exclusion Criteria:
- history of acute coronary syndrome or revascularization within the last 12 months,
- uncontrolled hypertension, defined as ≥180/≥110 mmHg or 160-179/100--109 mmHg despite treatment, or uncontrolled arrhythmia,
- conditions contraindicating the application of blood flow restriction training, such as significant peripheral arterial disease or atherosclerosis obliterans,
- severe orthopedic or neurological limitations that would prevent exercise,
- presence of atrial fibrillation or a pacemaker,
- severe liver disease,
- impaired renal function, defined as eGFR <30 mL/min,
- peripheral neuropathy,
- dialysis,
- moderate to severe valvular disease,
- moderate to severe COPD,
- hospitalization due to cardiovascular causes within the last 30 days,
- intracranial aneurysm, arteriovenous malformation, cerebral neoplasm, or abscess,
- angina pectoris and use of medications known to affect ischemic conditioning/occlusion, such as cyclosporine or glibenclamide,
- use of dual antiplatelet therapy or anticoagulants, including NOACs, low-molecular-weight heparin, or vitamin K antagonists.
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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Aerobic Exercise Plus Blood Flow Restriction Resistance Training
Participants in this group will receive an 8-week combined exercise program consisting of moderate-intensity aerobic exercise followed by blood flow restriction resistance training.
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Participants will receive an 8-week supervised combined exercise program performed 3 days per week on non-consecutive days.
The intervention will include moderate-intensity aerobic exercise on a cycle ergometer at 40-70% of heart rate reserve, followed by lower extremity-focused blood flow restriction resistance training using low loads corresponding to 20-40% of one-repetition maximum and cuff pressure set at 50% of arterial occlusion pressure.
Each session will include a 5-10-minute warm-up and a 5-10-minute cool-down period.
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실험적: Resistance Training Plus Blood Flow Restriction Aerobic Exercise
Participants in this group will receive an 8-week combined exercise program consisting of conventional resistance training followed by blood flow restriction aerobic exercise.
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Participants will receive an 8-week supervised combined exercise program performed 3 days per week on non-consecutive days.
The intervention will include conventional resistance training targeting major muscle groups at 40-60% of one-repetition maximum, followed by blood flow restriction aerobic exercise on a cycle ergometer at 40-70% of heart rate reserve.
Cuff pressure will be set at 50% of arterial occlusion pressure, and the cuffs will remain inflated only during the aerobic exercise period.
Each session will include a 5-10-minute warm-up and a 5-10-minute cool-down period.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Muscle Oxygen Saturation
기간: Baseline and after 8 weeks of intervention
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Muscle oxygen saturation will be assessed using near-infrared spectroscopy with the Moxy Monitor® device.
The device will be placed over the quadriceps muscle group, and muscle oxygen saturation values will be recorded.
SmO₂ reflects the balance between oxygen delivery and oxygen utilization in the working muscle.
Measurements will be obtained before and after the 8-week exercise intervention, and the mean SmO₂ value recorded during the measurement period will be used for analysis.
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Baseline and after 8 weeks of intervention
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Total Hemoglobin
기간: Baseline and after 8 weeks of intervention
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Total hemoglobin will be assessed using near-infrared spectroscopy with the Moxy Monitor® device placed over the quadriceps muscle group.
Total hemoglobin reflects local blood volume and hemodynamic changes in the measured muscle region.
Measurements will be obtained before and after the 8-week exercise intervention, and the mean THb value recorded during the measurement period will be used for analysis.
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Baseline and after 8 weeks of intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Brain Natriuretic Peptide Level
기간: Baseline and after 8 weeks of intervention
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Serum brain natriuretic peptide levels will be assessed using blood samples collected from all participants before and after the 8-week intervention.
Biochemical analyses will be performed by the responsible physician.
Serum BNP level will be used as a biomarker related to cardiac load and ventricular dysfunction in patients with heart failure.
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Baseline and after 8 weeks of intervention
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Functional Capacity
기간: Baseline and after 8 weeks of intervention
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Functional capacity will be assessed using the 6-Minute Walk Test according to standardized procedures.
Participants will be instructed to walk as far as possible at their own pace in a 30-meter corridor for 6 minutes.
The total distance walked at the end of the test will be recorded in meters.
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Baseline and after 8 weeks of intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Tanaka Y, Takarada Y. The impact of aerobic exercise training with vascular occlusion in patients with chronic heart failure. ESC Heart Fail. 2018 Aug;5(4):586-591. doi: 10.1002/ehf2.12285. Epub 2018 Mar 25.
- Groennebaek T, Sieljacks P, Nielsen R, Pryds K, Jespersen NR, Wang J, Carlsen CR, Schmidt MR, de Paoli FV, Miller BF, Vissing K, Botker HE. Effect of Blood Flow Restricted Resistance Exercise and Remote Ischemic Conditioning on Functional Capacity and Myocellular Adaptations in Patients With Heart Failure. Circ Heart Fail. 2019 Dec;12(12):e006427. doi: 10.1161/CIRCHEARTFAILURE.119.006427. Epub 2019 Dec 13.
- Vale-Lira A, Turri-Silva N, Verboven K, Durigan JLQ, de Lima ACGB, Bottaro M, Chiappa GR, Hansen D, Cipriano G Jr. Muscle-Skeletal Abnormalities and Muscle Oxygenation during Isokinetic Strength Exercise in Heart Failure with Preserved Ejection Fraction Phenotype: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Jan 9;19(2):709. doi: 10.3390/ijerph19020709.
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 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 9월 1일
연구 등록 날짜
최초 제출
2026년 5월 31일
QC 기준을 충족하는 최초 제출
2026년 5월 31일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 31일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HF-BFR
- 126S104 (기타 보조금/기금 번호: TÜBİTAK 1002 Project)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .