Clinical trial NCT06756646: Exploring the Effects of Aerobic Exercise Combined with BFRT on Patients with COPD
Official title: Exploring the Effects of Aerobic Exercise Combined with Blood Flow Restriction Training on Exercise Capacity, Cardiopulmonary Functions, and Quality of Life in Patients with Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Blood flow restriction training
Chronic Obstructive Pulmonary Disease
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxygen consumption (VO2)
timeFrame: Change from baseline (0 week) to follow up (20 weeks)
measure: Diaphragm capacity
timeFrame: Change from baseline (0 week) to follow up (20 weeks)
Secondary outcomes:
measure: Functional capacity
timeFrame: Change from baseline (0 week) to follow up (20 weeks)
measure: Heart Rate Variability
timeFrame: Change from baseline (0 week) to follow up (20 weeks)
measure: Pulmonary function test
timeFrame: Change from baseline (0 week) to follow up (20 weeks)
measure: Maximum respiratory pressure
timeFrame: Change from baseline (0 week) to follow up (20 weeks)
measure: Quality of life score (COPD-related questionnaire-I)
timeFrame: Change from baseline (0 week) to follow up (20 weeks)
measure: Quality of life score (COPD-related questionnaire-II)
timeFrame: Change from baseline (0 week) to follow up (20 weeks)
measure: Quality of life score (COPD-related questionnaire-III)
timeFrame: Change from baseline (0 week) to follow up (20 weeks)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hostipal
Study officials:
affiliation: Department of Physical Therapy, National Cheng Kung University
name: Kun-Ling Tsai, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: