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Blood Flow Restriction Combined With Aerobic or Resistance Exercise in Heart Failure

31 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Dilara AKAR ÇAMYAR, Principal Investigator
  • Numéro de téléphone: +905393291126
  • E-mail: f.dilaraakar@gmail.com

Lieux d'étude

  • Turquie (Türkiye)
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turquie (Türkiye), 34015
        • Biruni University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: Aerobic Exercise Plus Blood Flow Restriction Resistance Training
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.
Expérimental: 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.
Autre: Resistance Training Plus Blood Flow Restriction Aerobic Exercise
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Muscle Oxygen Saturation
Délai: 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.
Baseline and after 8 weeks of intervention
Total Hemoglobin
Délai: Baseline and after 8 weeks of intervention
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.
Baseline and after 8 weeks of intervention

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Serum Brain Natriuretic Peptide Level
Délai: 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.
Baseline and after 8 weeks of intervention
Functional Capacity
Délai: Baseline and after 8 weeks of intervention
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.
Baseline and after 8 weeks of intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Biruni University

Collaborateurs

The Scientific and Technological Research Council of Turkey

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 septembre 2027

Dates d'inscription aux études

Première soumission

31 mai 2026

Première soumission répondant aux critères de contrôle qualité

31 mai 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HF-BFR
  • 126S104 (Autre subvention/numéro de financement: TÜBİTAK 1002 Project)

Plan pour les données individuelles des participants (IPD)

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OUI

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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