Blood Flow Restriction Combined With Aerobic or Resistance Exercise in Heart Failure
2026年5月31日 更新者: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.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Dilara AKAR ÇAMYAR, Principal Investigator
- 电话号码:+905393291126
- 邮箱:f.dilaraakar@gmail.com
学习地点
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Zeytinburnu
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Istanbul、Zeytinburnu、土耳其(türkiye)、34015
- Biruni University
-
接触:
- Biruni University
- 电话号码:+90 444 8 276
- 邮箱:info@biruni.edu.tr
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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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实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Muscle Oxygen Saturation
大体时间:Baseline and after 8 weeks of intervention
|
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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serum Brain Natriuretic Peptide Level
大体时间:Baseline and after 8 weeks of intervention
|
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
大体时间: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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年9月1日
研究注册日期
首次提交
2026年5月31日
首先提交符合 QC 标准的
2026年5月31日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年5月31日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HF-BFR
- 126S104 (其他赠款/资助编号:TÜBİTAK 1002 Project)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.