NCT07261293 Effects of Blood Flow Restriction Aerobic Exercise on Inflammation, Hypoxia, Exercise Capacity, and Lung Function in COPD
| NCT ID | NCT07261293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istinye University |
| Condition | COPD (Chronic Obstructive Pulmonary Disease) |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2025-12-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Purpose: This study aims to compare the effects of the classical pulmonary rehabilitation (PR) program and blood flow restriction (BFR) applied during low-intensity aerobic exercise within PR on systemic inflammation, hypoxemia, exercise capacity, pulmonary function, respiratory muscle strength, and quality-of-life parameters in individuals with COPD. Methods: This randomized controlled study will include 34 individuals with COPD, allocated into a BFR aerobic group and a control group. Both groups will receive core PR components, including diaphragmatic breathing, pursed-lip breathing, respiratory muscle training, and peripheral muscle strengthening. The BFR group will perform low-intensity aerobic exercise with blood flow restriction, while the control group will perform moderate-intensity aerobic exercise without BFR in accordance with standard PR protocols. All sessions will be supervised by a physiotherapist, twice per week, for eight weeks. Systemic inflammation markers, arterial blood gases, pulmonary function, exercise capacity, quality of life, and symptom scores will be assessed before PR, after the 8th session, and at the end of the program. Data will be analyzed using SPSS 26.0. Expected Contribution: This study aims to provide evidence-based insights into the physiological and clinical effects of low-intensity BFR aerobic exercise within PR and to determine its potential advantages compared with classical PR. Additionally, it seeks to clarify whether low-intensity BFR aerobic exercise may serve as a better-tolerated alternative for COPD patients who experience exercise intolerance during moderate-intensity aerobic training.
Eligibility Criteria
Inclusion Criteria: * Individuals aged between 40 and 80 years * Clinically stable patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2024 criteria with post-bronchodilator FEV₁/FVC \< 0.70 * Stable clinical condition (no acute exacerbation within the past 4 weeks) * Individuals clinically evaluated and approved as suitable for pulmonary rehabilitation (PR) participation by a cardiology specialist * Functional capacity sufficient to participate in PR (e.g., 6-Minute Walk Test ≥150 m) * No contraindications to blood flow restriction (BFR) training (e.g., no peripheral vascular disease, no active thrombosis) * Ability to understand and follow instructions (adequate auditory and cognitive function) Exclusion Criteria: * Acute exacerbation of COPD, hospitalization, or systemic corticosteroid treatment within the past 4 weeks * Severe cardiovascular disease (uncontrolled hypertension \>180/110 mmHg, myocardial infarction within the past 6 months, unstable angina, congestive heart failure NYHA Class III-IV) * Neurological or orthopedic conditions significantly limiting lower-extremity function (e.g., hemiplegia, amputation, severe osteoarthritis, knee prosthesis) * Severe renal impairment (GFR \<30 mL/min/1.73 m²) or severe hepatic failure * History of lower-extremity surgery within the past 3 months * Active malignancy or systemic infection * Anemia or chronic inflammatory/autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease) * History of venous thromboembolism * Peripheral arterial disease * Physician-diagnosed sarcopenia * Psychiatric disorders (major depression, dementia, psychotic disorders) limiting adherence to the study protocol
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07261293 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying COPD (Chronic Obstructive Pulmonary Disease). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07261293 currently recruiting?
Yes, NCT07261293 is actively recruiting participants. Contact the research team at fahrettin.ozelci@stu.istinye.edu.tr for enrollment information.
Where is the NCT07261293 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07261293 clinical trial?
NCT07261293 is sponsored by Istinye University. The trial plans to enroll 34 participants.
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