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

NCT07627737 | Not Yet Recruiting

• 2 other identifiers: HF-BFR126S104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

heart failure; cardiopulmonary rehabilitation; blood flow restriction training; aerobic exercise; resistance exercise; cardiac markers

Outcome Measures

Primary Outcomes (2)

• Muscle Oxygen Saturation

  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

  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

Secondary Outcomes (2)

• Serum Brain Natriuretic Peptide Level

  Baseline and after 8 weeks of intervention

• Functional Capacity

  Baseline and after 8 weeks of intervention

Study Arms (2)

Aerobic Exercise Plus Blood Flow Restriction Resistance Training

EXPERIMENTAL

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.

Other: Aerobic Exercise Plus Blood Flow Restriction Resistance Training

Resistance Training Plus Blood Flow Restriction Aerobic Exercise

EXPERIMENTAL

Participants in this group will receive an 8-week combined exercise program consisting of conventional resistance training followed by blood flow restriction aerobic exercise.

Other: Resistance Training Plus Blood Flow Restriction Aerobic Exercise

Interventions

Aerobic Exercise Plus Blood Flow Restriction Resistance Training OTHER

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.

Aerobic Exercise Plus Blood Flow Restriction Resistance Training

Resistance Training Plus Blood Flow Restriction Aerobic Exercise OTHER

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.

Resistance Training Plus Blood Flow Restriction Aerobic Exercise

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biruni University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, 34015, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 31830830 BACKGROUND

• 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.

  PMID: 35055531 BACKGROUND

• 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.

  PMID: 29575708 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Central Study Contacts

Dilara AKAR ÇAMYAR, Principal Investigator

CONTACT

+905393291126; f.dilaraakar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)