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Chronic Obstructive Pulmonary DiseaseCOPDNCT07860008

Effects of TPB-Based Cadence Exercise and Breathing Training on Physiological Parameters and Quality of Life in Patients With COPD

A study testing Breathing Training and Cadence Exercise in people with Chronic Obstructive Pulmonary Disease, run by Fu Jen Catholic University Hospital at 2 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This randomized controlled trial aims to evaluate the effects of a Theory of Planned Behavior (TPB)-based intervention incorporating cadence exercise and breathing training on physiological parameters and quality of life in patients with chronic obstructive pulmonary disease (COPD). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Breathing Training and Cadence Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesTaiwan
Study dates
6 Oct 2026to 25 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Inclusion Criteria:Adults aged 40 years or older. Diagnosed with chronic obstructive pulmonary disease (COPD). Able to understand the study procedures and provide informed consent. Able to participate in respiratory training and/or step-frequency exercise as instructed by the researchers.

Able to complete the questionnaires and physical assessments required by the study.

-

Exclusion Criteria:Acute exacerbation of COPD or unstable clinical condition during the study period.

Severe cardiovascular, musculoskeletal, neurological, or other medical conditions that may interfere with participation in the intervention or outcome assessments.

Cognitive or communication impairment that prevents completion of the study procedures or questionnaires.

Unable to safely perform the required respiratory training or step-frequency exercise.

Participation in another clinical intervention study that may affect the outcomes of this study.

-

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

CHIA JUNG CHANG, RN contact

+886929228555

jamine970807@gmail.com

Taiwan2 sites, 2 recruiting
  • Fu Jen Catholic University Hospital

    New Taipei City, New Taipei City, 242062

    CHIA JUNG CHANG, RN, +886929228555, jamine970807@gmail.com

    Not yet recruiting
  • Taipei Hospital, Ministry of Health and Welfare

    New Taipei City, New Taipei City

    CHIA JUNG CHANG, RN, *886929228555, jamine970807@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: The Effects of a Theory of Planned Behavior-Based Intervention Incorporating Cadence Exercise and Breathing Training on Physiological Parameters and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease

This randomized controlled trial aims to evaluate the effects of a Theory of Planned Behavior (TPB)-based intervention incorporating cadence exercise and breathing training on physiological parameters and quality of life in patients with chronic obstructive pulmonary disease (COPD). Eligible participants will be randomly assigned to receive breathing training, cadence exercise, a combined intervention of breathing training and cadence exercise, or usual care. The intervention will be conducted for 12 weeks, with assessments at baseline, Week 8, and Week 12. The study will evaluate changes in physiological parameters, exercise capacity, respiratory muscle strength, and quality of life. The findings may provide evidence for developing behavioral interventions to support pulmonary rehabilitation and improve health outcomes in people with COPD.

Read the detailed description

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory condition that can cause persistent respiratory symptoms, reduced exercise capacity, impaired respiratory muscle function, and decreased quality of life. Pulmonary rehabilitation and regular physical activity are important components of COPD management; however, adherence to exercise and respiratory training may be affected by individual behavioral factors.

This randomized controlled trial is designed based on the Theory of Planned Behavior (TPB), which proposes that attitudes, subjective norms, and perceived behavioral control influence behavioral intention and subsequent health behaviors. The study aims to evaluate whether a TPB-based intervention incorporating cadence exercise and breathing training can improve physiological parameters and quality of life in patients with COPD.

Eligible participants will be randomly assigned to one of four groups: a breathing training group, a cadence exercise group, a combined breathing training and cadence exercise group, or a usual-care control group. Participants in the breathing training group will perform respiratory muscle training using an adjustable respiratory muscle training device. Participants in the cadence exercise group will perform walking exercise guided by a metronome at a predetermined cadence. Participants in the combined intervention group will receive both breathing training and cadence exercise. The usual-care group will receive routine clinical care.

The intervention period will be 12 weeks. Participants will be assessed at baseline (T0), Week 8 (T1), and Week 12 (T2). Outcome assessments will include physiological parameters, respiratory muscle strength, pulmonary function, exercise capacity, dyspnea, and health-related quality of life. Physiological and functional outcomes will include oxygen saturation, heart rate, respiratory rate, maximal inspiratory pressure, maximal expiratory pressur and the six-minute walk test. Quality of life and COPD-related symptoms will be assessed using validated instruments.

The study will also assess TPB-related constructs, including attitude, subjective norm, perceived behavioral control, and behavioral intention, to explore behavioral factors associated with adherence to the intervention. The study findings are expected to provide evidence regarding the effectiveness of cadence exercise and breathing training, individually and in combination, and to contribute to the development of behaviorally informed pulmonary rehabilitation strategies for patients with COPD.

Being tested
Breathing Training, Cadence Exercise, Usual Care
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Theory of Planned Behavior, Cadence Exercise, Breathing Training, Pulmonary Rehabilitation, Respiratory Muscle Training, Quality of Life
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breathing TrainingBehavioural

    A 12-week respiratory muscle training intervention based on the Theory of Planned Behavior. Participants will perform breathing training using an adjustable respiratory muscle training device according to a standardized training protocol. The intervention includes standardized instruction and training materials to support adherence.

  • Cadence ExerciseBehavioural

    A 12-week cadence-guided walking exercise intervention based on the Theory of Planned Behavior. Participants will perform walking exercise using a metronome to guide the prescribed cadence according to a standardized training protocol. The intervention includes standardized instruction and training materials to support adherence.

  • Usual CareOther

    Participants in this group will receive usual clinical care for chronic obstructive pulmonary disease according to routine clinical practice. No additional breathing training or cadence exercise intervention will be provided as part of the study.

Study groups in NCT07860008
Study groupRoleWhat they receive
Breathing Training GroupExperimentalParticipants in this group will receive a 12-week breathing training intervention based on the Theory of Planned Behavior. Respiratory muscle training will be performed using an adjustable respiratory muscle training device according to the standardized training protocol. Participants will receive instructions and training materials to support adherence to the intervention.
Receives: Behavioral: Breathing Training
Cadence Exercise GroupExperimentalParticipants in this group will receive a 12-week cadence exercise intervention based on the Theory of Planned Behavior. Walking exercise will be performed with a metronome to guide the prescribed cadence according to the standardized training protocol. Participants will receive instructions and training materials to support adherence to the intervention.
Receives: Behavioral: Cadence Exercise
Combined Breathing Training + Cadence Exercise GroupExperimentalParticipants in this group will receive a 12-week combined intervention consisting of breathing training and cadence exercise based on the Theory of Planned Behavior. Participants will perform breathing training followed by cadence-guided walking exercise according to the standardized training protocol. Instructions and training materials will be provided to support adherence to the intervention.
Receives: Behavioral: Breathing Training; Behavioral: Cadence Exercise
Usual Care GroupActive comparatorParticipants in this group will receive usual clinical care for chronic obstructive pulmonary disease according to routine clinical practice. No additional breathing training or cadence exercise intervention will be provided as part of the study.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Inspiratory Pressure (MIP)

    Maximal inspiratory pressure (MIP) will be measured to evaluate respiratory muscle strength.

    Measured: Baseline (T0), Week 8 (T1), and Week 12 (T2)

  2. Maximal Expiratory Pressure (MEP)

    Maximal expiratory pressure (MEP) will be measured to evaluate respiratory muscle strength.

    Measured: Baseline (T0), Week 8 (T1), and Week 12 (T2)

  3. Oxygen Saturation (SpO₂)

    Oxygen saturation (SpO₂) will be measured to evaluate physiological status.

    Measured: Baseline (T0), Week 8 (T1), and Week 12 (T2)

  4. Six-Minute Walk Test (6MWT)

    Six-minute walk test (6MWT) distance will be measured to evaluate exercise capacity.

    Measured: Baseline (T0), Week 8 (T1), and Week 12 (T2)

  5. COPD Assessment Test (CAT)

    COPD Assessment Test (CAT) score will be used to assess the impact of COPD symptoms on patients' health status and quality of life.

    Measured: Baseline (T0), Week 8 (T1), and Week 12 (T2)

  6. Modified Medical Research Council Dyspnea Scale (mMRC)

    Modified Medical Research Council Dyspnea Scale (mMRC) score will be used to assess the severity of dyspnea in patients with COPD.

    Measured: Baseline (T0), Week 8 (T1), and Week 12 (T2)

  7. St. George's Respiratory Questionnaire (SGRQ)

    St. George's Respiratory Questionnaire (SGRQ) score will be used to assess health-related quality of life in patients with COPD.

    Measured: Baseline (T0), Week 8 (T1), and Week 12 (T2)

  8. WHOQOL-BREF (Taiwan Version)

    WHOQOL-BREF (Taiwan Version) score will be used to assess health-related quality of life.

    Measured: Baseline (T0), Week 8 (T1), and Week 12 (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2026
  2. Study start6 Oct 2026 (estimated)
  3. Primary completion25 Dec 2027 (estimated)
  4. Study completion25 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07860008
Sponsor's protocol ID
FJUH115606
Other IDs
FJUH115606
Acronym
COPD
Status last verified
Oct 2026
First submitted
30 Sep 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers because of participant confidentiality and privacy considerations. The data will be used only for the purposes specified in the approved study protocol and informed consent.

Publications

  • Zeng Y, Wu Q, Chen Y, Cai S. Early comprehensive pulmonary rehabilitation for hospitalized patients with acute ex-acerbation of chronic obstructive pulmonary disease: a randomized controlled trial. J Rehabil Med. 2024 Aug 22;56:jrm39953. doi: 10.2340/jrm.v56.39953.

    PubMed 39175447
  • Aktan R, Ozalevli S, Yakut H, Ozgen Alpaydin A. The effects of inspiratory muscle warm-up prior to inspiratory muscle training during pulmonary rehabilitation in subjects with chronic obstructive pulmonary disease: a randomized trial. Physiother Theory Pract. 2025 Jan;41(1):1-11. doi: 10.1080/09593985.2023.2301439. Epub 2024 Jan 11.

    PubMed 38205730
  • Ceyhan Y, Tekinsoy Kartin P. The effects of breathing exercises and inhaler training in patients with COPD on the severity of dyspnea and life quality: a randomized controlled trial. Trials. 2022 Aug 26;23(1):707. doi: 10.1186/s13063-022-06603-3.

    PubMed 36028881
  • Yun R, Bai Y, Lu Y, Wu X, Lee SD. How Breathing Exercises Influence on Respiratory Muscles and Quality of Life among Patients with COPD? A Systematic Review and Meta-Analysis. Can Respir J. 2021 Jan 29;2021:1904231. doi: 10.1155/2021/1904231. eCollection 2021.

    PubMed 33574969
  • Ammous O, Feki W, Lotfi T, Khamis AM, Gosselink R, Rebai A, Kammoun S. Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2023 Jan 6;1(1):CD013778. doi: 10.1002/14651858.CD013778.pub2.

    PubMed 36606682

Questions about this trial

What is this clinical trial studying?

A study testing Breathing Training and Cadence Exercise in people with Chronic Obstructive Pulmonary Disease, run by Fu Jen Catholic University Hospital at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact CHIA JUNG CHANG, RN (+886929228555, jamine970807@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Inspiratory Pressure (MIP) (time frame: Baseline (T0), Week 8 (T1), and Week 12 (T2)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07860008, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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