Blood Flow Restriction Combined With Aerobic or Resistance Exercise in Heart Failure
ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorBiruni University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic Exercise Plus Blood Flow Restriction Resistance Training
Other interventionParticipants 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 Exercise
Other interventionParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Aerobic Exercise Plus Blood Flow Restriction Resistance TrainingExperimental treatment 1 intervention
Group B: Resistance Training Plus Blood Flow Restriction Aerobic ExerciseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 intervention2
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 interventionSecondary outcomes
1
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 intervention2
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 interventionSponsors and contacts
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Biruni University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator
Source ClinicalTrials.gov
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