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

31. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Dilara AKAR ÇAMYAR, Principal Investigator
  • Telefonnummer: +905393291126
  • E-mail: f.dilaraakar@gmail.com

Studiesteder

  • Tyrkiet (Türkiye)
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Tyrkiet (Türkiye), 34015
        • Biruni University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Muscle Oxygen Saturation
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum Brain Natriuretic Peptide Level
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biruni University

Samarbejdspartnere

The Scientific and Technological Research Council of Turkey

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

31. maj 2026

Først indsendt, der opfyldte QC-kriterier

31. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HF-BFR
  • 126S104 (Andet bevillings-/finansieringsnummer: TÜBİTAK 1002 Project)

Plan for individuelle deltagerdata (IPD)

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  • STUDY_PROTOCOL

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