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Recruiting NCT06756646

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

No phase Interventional Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic exercise intervention, Disease and exercise suggestion, Blood flow restriction (BFR) intervention.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 30 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Behavioral Aerobic exercise intervention
    The aerobic exercise intervention will utilize an ergometer. The program will be conducted 2-3 times per week over a 3-month period.
  • Behavioral Disease and exercise suggestion
    The participants will be provided by educational program about COPD self-care and home-based exercise approach.
  • Behavioral Blood flow restriction (BFR) intervention
    Blood flow restriction (BFR) intervention will combine aerobic exercise on the ergometer with BFR training. The program will be conducted 2-3 times per week over a 3-month period.

Primary outcome measures

  • Oxygen consumption (VO2) [Time frame: Change from baseline (0 week) to follow up (20 weeks)]
  • Diaphragm capacity [Time frame: Change from baseline (0 week) to follow up (20 weeks)]
Secondary outcome measures (7)
  • Functional capacity [Time frame: Change from baseline (0 week) to follow up (20 weeks)]
  • Heart Rate Variability [Time frame: Change from baseline (0 week) to follow up (20 weeks)]
  • Pulmonary function test [Time frame: Change from baseline (0 week) to follow up (20 weeks)]
  • Maximum respiratory pressure [Time frame: Change from baseline (0 week) to follow up (20 weeks)]
  • Quality of life score (COPD-related questionnaire-I) [Time frame: Change from baseline (0 week) to follow up (20 weeks)]
  • Quality of life score (COPD-related questionnaire-II) [Time frame: Change from baseline (0 week) to follow up (20 weeks)]
  • Quality of life score (COPD-related questionnaire-III) [Time frame: Change from baseline (0 week) to follow up (20 weeks)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Taiwan · 1 center
  • National Cheng Kung University Hostipal — Tainan

Identifiers

NCT: NCT06756646 · B-ER-113-298

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗