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

Official title

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

Overview

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.

Interventions

• 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 an
• 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.

Primary outcome measures

• Muscle Oxygen Saturation [Time frame: Baseline and after 8 weeks of intervention]
• Total Hemoglobin [Time frame: Baseline and after 8 weeks of intervention]

Secondary outcome measures (2)

• Serum Brain Natriuretic Peptide Level [Time frame: Baseline and after 8 weeks of intervention]
• Functional Capacity [Time frame: Baseline and after 8 weeks of intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Biruni University — Istanbul

Publications

• 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 201 PMID 31830830
• 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
• 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

Identifiers

NCT: NCT07627737 · HF-BFR · 126S104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗