Exploring the Effects of Aerobic Exercise Combined with BFRT on Patients with COPD

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT06756646
• Lead Sponsor: National Cheng Kung University

Brief Summary

Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in COPD patients.

Detailed Description

The systemic effects of Chronic Obstructive Pulmonary Disease (COPD) can precipitate a series of complications, including cardiovascular disorders, muscle atrophy, and osteoporosis. These comorbid conditions often result in decreased physical activity and suboptimal physical fitness, compelling patients to lead a sedentary lifestyle to mitigate exercise-induced dyspnea. Addressing the limitations in exercise tolerance remains a critical therapeutic goal in the treatment of COPD. According to research, exercise intolerance is caused by both poor pulmonary function and associated skeletal muscle dysfunction. Blood flow restriction training, a new rehabilitation technique, has shown promise in improving muscular strength at lower exercise intensities and in shorter timeframes, presenting a fresh approach to COPD rehabilitation.

The research aims to investigate the impact of incorporating blood flow restriction training into a holistic aerobic exercise program on exercise capacity and quality of life among patients with COPD. The findings are intended to clarify the potential of this innovative training technique as a supplementary therapeutic strategy in the management of COPD.

Study Timeline

• Study Start: 2024-11-20
• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-25
• Last Update Submitted: 2024-12-25
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. COPD classified as levels 2-4.
2. Stable condition without worsening in the past three months.
3. No participation in any rehabilitation program within the past six months.
4. Ability to understand and follow verbal commands and cooperate with an exercise training program.

Exclusion Criteria

1. Unconscious or unable to cooperate with the evaluator.
2. Hospitalization due to acute illness within the past three months.
3. Severe joint diseases or history of lower limb surgery.
4. Severe cardiovascular disease (e.g., presence of a cardiac pacemaker or acute myocardial infarction within the past six months).
5. Dependence on oxygen supply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oxygen consumption (VO2)	Change from baseline (0 week) to follow up (20 weeks)	Oxygen consumption examined by cardiopulmonary exercise test
Diaphragm capacity	Change from baseline (0 week) to follow up (20 weeks)	Diaphragm capacity examined by diaphragmatic ultrasound

Secondary Outcome Measures

Name	Time	Method
Functional capacity	Change from baseline (0 week) to follow up (20 weeks)	Functional capacity examined by 6MWT
Heart Rate Variability	Change from baseline (0 week) to follow up (20 weeks)	Heart Rate Variability examined by autonomic nervous system
Pulmonary function test	Change from baseline (0 week) to follow up (20 weeks)	Pulmonary function test examined by spirometer. Spirometry is a physiological test that measures the ability to inhale and exhale air over time. The main spirometry results are forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and the FEV1/FVC ratio.
Maximum respiratory pressure	Change from baseline (0 week) to follow up (20 weeks)	Maximum respiratory pressure examined by pressure meter
Quality of life score (COPD-related questionnaire-I)	Change from baseline (0 week) to follow up (20 weeks)	Quality of life score examined by mMRC Questionnaire.
Quality of life score (COPD-related questionnaire-II)	Change from baseline (0 week) to follow up (20 weeks)	COPD Assessment Test (CAT) questionaire
Quality of life score (COPD-related questionnaire-III)	Change from baseline (0 week) to follow up (20 weeks)	St George's Respiratory Questionnaire (SGRQ)

Trial Locations

Locations (1)

National Cheng Kung University Hostipal; 🇨🇳 Tainan, Taiwan