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

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Disease and exercise suggestion; Behavioral: Aerobic exercise intervention; Behavioral: Blood flow restriction (BFR) intervention

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kun-Ling Tsai, Ph.D.; Phone Number: 5078 886-6-2353535; Email: kunlingtsai@mail.ncku.edu.tw
• Study Contact Backup: Name: Yu-Ting Huang, M.S.; Phone Number: 5078 886-6-2353535; Email: t66061053@pt.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 701
    • Recruiting
    • National Cheng Kung University Hostipal
    • Contact: Kun-Ling Tsai, PhD; Phone Number: 6219 062353535; Email: kunlingtsai@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care group; The Usual care group will receive COPD and exercise-related education.	Behavioral: Disease and exercise suggestion; The participants will be provided by educational program about COPD self-care and home-based exercise approach.
Experimental: Aerobic exercise group-cycling; The aerobic exercise group will receive cycling training intervention 2-3 times per week for 2 months.	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.
Experimental: BFR group-cycling + BFR; The BFR group will receive cycling training combined with BFR intervention 2-3 times per week for 2 months.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	Functional capacity examined by 6MWT	Change from baseline (0 week) to follow up (20 weeks)
Heart Rate Variability	Heart Rate Variability examined by autonomic nervous system	Change from baseline (0 week) to follow up (20 weeks)
Pulmonary function test	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.	Change from baseline (0 week) to follow up (20 weeks)
Maximum respiratory pressure	Maximum respiratory pressure examined by pressure meter	Change from baseline (0 week) to follow up (20 weeks)
Quality of life score (COPD-related questionnaire-I)	Quality of life score examined by mMRC Questionnaire.	Change from baseline (0 week) to follow up (20 weeks)
Quality of life score (COPD-related questionnaire-II)	COPD Assessment Test (CAT) questionaire	Change from baseline (0 week) to follow up (20 weeks)
Quality of life score (COPD-related questionnaire-III)	St George's Respiratory Questionnaire (SGRQ)	Change from baseline (0 week) to follow up (20 weeks)

Collaborators and Investigators

• Sponsor: National Cheng Kung University
• Investigators: Principal Investigator: Kun-Ling Tsai, Ph.D., Department of Physical Therapy, National Cheng Kung University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Blood flow restriction training
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: B-ER-113-298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD sharing plan will be decided after summarized data being published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No