Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

Find Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials Near You

Effects of Blood Flow Restriction Aerobic Exercise on Systemic Inflammation, Hypoxia, Exercise Capacity, and Pulmonary Functions in Patients With Chronic Obstructive Pulmonary Disease: A Prospective Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Turkey
Sultan Abdulhamid Han Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
Fahrettin Özelçi
fahrettin.ozelci@stu.istinye.edu.tr
+90 531 886 5717
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 34
Treatments
Active_comparator: Blood Flow Restriction Aerobic Exercise Group
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.
Active_comparator: Conventional Aerobic Exercise Group
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.
Sponsors
Leads: Istinye University

This content was sourced from clinicaltrials.gov