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

N/ANot Yet RecruitingNCT07627737

Biruni University40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Interventions

Aerobic Exercise Plus Blood Flow Restriction Resistance TrainingOTHER

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.

Resistance Training Plus Blood Flow Restriction Aerobic ExerciseOTHER

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.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline and after 8 weeks of intervention

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline and after 8 weeks of intervention

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts