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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Aerobic Exercise Plus Blood Flow Restriction Resistance Training; Other: Resistance Training Plus Blood Flow Restriction Aerobic Exercise

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dilara AKAR ÇAMYAR, Principal Investigator; Phone Number: +905393291126; Email: f.dilaraakar@gmail.com

Study Locations

• Turkey (Türkiye)
  • Zeytinburnu
    • Istanbul, Zeytinburnu, Turkey (Türkiye), 34015
      • Biruni University
      • Contact: Biruni University; Phone Number: +90 444 8 276; Email: info@biruni.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Brain Natriuretic Peptide Level	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	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

Collaborators and Investigators

• Sponsor: Biruni University
• Collaborators: The Scientific and Technological Research Council of Turkey

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: aerobic exercise; heart failure; resistance exercise; blood flow restriction training; cardiopulmonary rehabilitation; cardiac markers
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: HF-BFR; 126S104 (Other Grant/Funding Number: TÜBİTAK 1002 Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No