Effects of Blood Flow Restriction Aerobic Exercise on Inflammation, Hypoxia, Exercise Capacity, and Lung Function in COPD

NCT07261293 | Not Yet Recruiting DMC

• 1 other identifier: ISTU-BFRAE-COPD25
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; BFR; Aerobic exercise; Exercise capacity

Outcome Measures

Primary Outcomes (1)

• Change in Exercise Capacity

  Exercise capacity will be evaluated using the 6-Minute Walk Test (6MWT), conducted according to ATS guidelines in a 30-meter corridor. The total distance walked in 6 minutes (6MWD) will be recorded as the primary indicator of functional exercise capacity. The outcome measure will assess the change in 6MWT distance from baseline to 8 weeks following the intervention in COPD patients undergoing pulmonary rehabilitation with or without blood flow restriction (BFR). An increase in 6MWD reflects improvement in exercise capacity.

  Baseline and 8 weeks after intervention

Secondary Outcomes (5)

• Change in Systemic Inflammation (CRP Levels)

  Baseline and 8 weeks after intervention

• Change in Systemic Inflammation (RDW Levels)

  Baseline and 8 weeks after intervention

• Change in Arterial Oxygen Partial Pressure (PaO₂)

  Baseline and 8 weeks after intervention

• Change in Respiratory Function (FEV₁)

  Baseline and 8 weeks after intervention

• Change in Respiratory Muscle Strength (MIP)

  Baseline and 8 weeks after intervention

Other Outcomes (2)

• Change in Peripheral Muscle Strength (Quadriceps Strength)

  Baseline and 8 weeks after intervention

• Change in Dyspnea (mMRC Score)

  Baseline and 8 weeks after intervention

Study Arms (2)

Blood Flow Restriction Aerobic Exercise Group

ACTIVE COMPARATOR

Participants in this group will perform low-intensity aerobic exercise on a cycle ergometer under blood flow restriction (BFR) as part of pulmonary rehabilitation. BFR pressure will be applied bilaterally to the proximal thighs using pneumatic cuffs at 40-50% of each participant's limb occlusion pressure. Sessions will include warm-up, 15 minutes of aerobic exercise, and cool-down, supervised by a physiotherapist. No aerobic exercise without BFR will be performed in this arm.

Behavioral: Blood Flow Restriction Aerobic Exercise Training

Conventional Aerobic Exercise Group

ACTIVE COMPARATOR

Participants in this arm will perform standard aerobic exercise on a cycle ergometer as part of conventional pulmonary rehabilitation without blood flow restriction. Exercise intensity will be prescribed at 60-80% of the target heart rate calculated using the Karvonen formula. Each session will include a 3-minute warm-up, 15 minutes of continuous aerobic exercise, and a 3-minute cool-down. Exercise intensity, frequency, and duration will be matched to the BFR aerobic exercise group. All sessions will be supervised by an experienced physiotherapist. No blood flow restriction will be applied in this arm.

Behavioral: Conventional Aerobic Exercise Training

Interventions

Blood Flow Restriction Aerobic Exercise Training BEHAVIORAL

Blood Flow Restriction Aerobic Exercise Training Participants will undergo aerobic exercise performed with blood flow restriction (BFR) applied to both thighs using pneumatic cuffs positioned at the proximal portion of the lower limbs. Cuff pressure will be individualized for each participant based on limb occlusion pressure (LOP), determined by Doppler assessment. During training, cuffs will be inflated to 40-50% of the participant's LOP and will remain inflated throughout the aerobic exercise phase. Sessions will include warm-up, continuous low-intensity cycling, and cool-down, supervised by a physiotherapist. The purpose of this intervention is to induce physiological adaptations associated with BFR, such as increased metabolic stress and muscular activation, while using low mechanical load.

Blood Flow Restriction Aerobic Exercise Group

Conventional Aerobic Exercise Training BEHAVIORAL

Participants in this group will perform aerobic exercise on a cycle ergometer without blood flow restriction (BFR) as part of standard pulmonary rehabilitation. The aerobic exercise protocol will be performed at 60-80% of the participant's target heart rate (THR), calculated using the Karvonen formula: THR = \[(HRmax - HRrest) × % intensity\] + HRrest. Training will be performed twice per week for a total of 8 weeks and will include 3 minutes of warm-up, 15 minutes of target-intensity aerobic cycling, and 3 minutes of cool-down (total duration: 21 minutes). Pedal resistance and cadence will be adjusted according to the Borg Rating of Perceived Exertion (RPE), with the target RPE maintained between 3 and 4. Exercise intensity (watt level) will be progressed weekly by approximately 5-10%, aligned with tolerance and RPE scores (Patterson et al., 2019). No BFR will be applied at any stage of the intervention.

Conventional Aerobic Exercise Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Related Publications (1)

• Agustí, A., & Hogg, J. C. (2019). Update on the pathogenesis of chronic obstructive pulmonary disease. New England Journal of Medicine, 381(13), 1248-1256. Almeida, C. N. S., Fiel, J. A., Sarges, E. S. N. F., et al. (2020). Physiological response to the Glittre-ADL test in elderly COPD patients. Fisioterapia em Movimento, 33, e003322. Centner, C., et al. (2019). Low-load blood flow restriction training induces similar morphological and strength adaptations to high-load resistance training. Journal of Applied Physiology, 127(6), 1643-1655. Geddes, E. L., O'Brien, K., Reid, W. D., et al. (2008). Inspiratory muscle training in adults with chronic obstructive pulmonary disease: a systematic review. Respiratory Medicine, 102(12), 1715-1729. Global Initiative for Chronic Obstructive Lung Disease. (2024). Global strategy for the diagnosis, management, and prevention of COPD: 2024 Report. Gosselink, R., et al. (2011). Impact of inspiratory muscle training in patients with COPD: What is the evidence? European Respiratory Journal, 37(2), 416-425. Grønfeldt, B.M., Lindberg Nielsen, J., Mieritz, R.M., Lund, H. & Aagaard, P. (2020) Effect of blood-flow restricted vs heavy-load strength train ing on muscle strength: systematic review and meta-analysis. Scandinavian Journal of Medicine & Science in Sports, 30(5), 837-848. Guo, C. L., Sun, H. J., & Li, J. (2023). Neutrophil-to-lymphocyte ratio as a marker of COPD severity. Respiratory Medicine, 195, 106900. Hassan, A., & Jabbar, N. (2022). C-reactive protein as a predictor of severity in chronic obstructive pulmonary disease: An experience from a tertiary care hospital. Cureus, 14(8). Kohlbrenner, D., Kuhn, M., Manettas, A., Aregger, C., Peterer, M., Greco, N., ... & Clarenbach, C. (2024). Low-load blood flow restriction strength training in patients with COPD: a randomised single-blind pilot study. Thorax, 79(4), 340-348. Laghi, F., & Tobin, M. J. (2003). Disorders of the respiratory muscles. American Journal of Respirator

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fahrettin Özelçi

CONTACT

+90 531 886 5717; fahrettin.ozelci@stu.istinye.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share