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

NCT06756646 | Recruiting

• 1 other identifier: B-ER-113-298
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Blood flow restriction training; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Functional capacity

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

• Heart Rate Variability

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

• Pulmonary function test

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

• Maximum respiratory pressure

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

• Quality of life score (COPD-related questionnaire-I)

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

Study Arms (3)

Usual care group

ACTIVE COMPARATOR

The Usual care group will receive COPD and exercise-related education.

Behavioral: Disease and exercise suggestion

Aerobic exercise group-cycling

EXPERIMENTAL

The aerobic exercise group will receive cycling training intervention 2-3 times per week for 2 months.

Behavioral: Aerobic exercise intervention

BFR group-cycling + BFR

EXPERIMENTAL

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

Interventions

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.

Aerobic exercise group-cycling

Disease and exercise suggestion BEHAVIORAL

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

Usual care group

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.

BFR group-cycling + BFR

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University Hostipal

Tainan, Taiwan, 701, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Methods

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Kun-Ling Tsai, Ph.D.

  Department of Physical Therapy, National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun-Ling Tsai, Ph.D.

CONTACT

886-6-2353535; kunlingtsai@mail.ncku.edu.tw

Yu-Ting Huang, M.S.

CONTACT

886-6-2353535; t66061053@pt.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Physical Therapy

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 3, 2025
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)