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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Dilara AKAR ÇAMYAR, Principal Investigator
- 電話番号：+905393291126
- メール：f.dilaraakar@gmail.com
研究場所
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Zeytinburnu
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Istanbul、Zeytinburnu、トルコ（Türkiye）、34015
- Biruni University
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コンタクト：
- Biruni University
- 電話番号：+90 444 8 276
- メール：info@biruni.edu.tr
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Muscle Oxygen Saturation
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Serum Brain Natriuretic Peptide Level
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年9月1日
試験登録日
最初に提出
2026年5月31日
QC基準を満たした最初の提出物
2026年5月31日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年5月31日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- HF-BFR
- 126S104 (その他の助成金/資金番号：TÜBİTAK 1002 Project)
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個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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