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NCT Number: NCT06756646

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

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

Recruiting

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hostipal

Tainan, Taiwan, 701

Location status: Recruiting

Location contact

Kun-Ling Tsai, PhD

CONTACT

[email protected]

062353535 ext. 6219

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic exercise intervention

Behavioral

The aerobic exercise intervention will utilize an ergometer. The program will be conducted 2-3 times per week over a 3-month period.

Disease and exercise suggestion

Behavioral

The participants will be provided by educational program about COPD self-care and home-based exercise approach.

Blood flow restriction (BFR) intervention

Behavioral

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 outcomes

  1. Oxygen consumption (VO2)

    Time frame: Change from baseline (0 week) to follow up (20 weeks)

    Oxygen consumption examined by cardiopulmonary exercise test

  2. Diaphragm capacity

    Time frame: Change from baseline (0 week) to follow up (20 weeks)

    Diaphragm capacity examined by diaphragmatic ultrasound

Secondary outcomes

  1. Functional capacity

    Time frame: Change from baseline (0 week) to follow up (20 weeks)

    Functional capacity examined by 6MWT

  2. Heart Rate Variability

    Time frame: Change from baseline (0 week) to follow up (20 weeks)

    Heart Rate Variability examined by autonomic nervous system

  3. Pulmonary function test

    Time frame: 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.

  4. Maximum respiratory pressure

    Time frame: Change from baseline (0 week) to follow up (20 weeks)

    Maximum respiratory pressure examined by pressure meter

  5. Quality of life score (COPD-related questionnaire-I)

    Time frame: Change from baseline (0 week) to follow up (20 weeks)

    Quality of life score examined by mMRC Questionnaire.

  6. Quality of life score (COPD-related questionnaire-II)

    Time frame: Change from baseline (0 week) to follow up (20 weeks)

    COPD Assessment Test (CAT) questionaire

  7. Quality of life score (COPD-related questionnaire-III)

    Time frame: Change from baseline (0 week) to follow up (20 weeks)

    St George's Respiratory Questionnaire (SGRQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Kun-Ling Tsai, Ph.D.

CONTACT

[email protected]

886-6-2353535 ext. 5078

Yu-Ting Huang, M.S.

CONTACT

[email protected]

886-6-2353535 ext. 5078

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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