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

NCT07860008 | Recruiting

• 1 other identifier: FJUH115606
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Theory of Planned Behavior; Cadence Exercise; Breathing Training; Pulmonary Rehabilitation; Respiratory Muscle Training; Quality of Life

Outcome Measures

Primary Outcomes (8)

• Maximal Inspiratory Pressure (MIP)

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

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

• Maximal Expiratory Pressure (MEP)

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

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

• Oxygen Saturation (SpO₂)

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

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

• Six-Minute Walk Test (6MWT)

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

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

• 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.

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

• 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.

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

• 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.

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

• WHOQOL-BREF (Taiwan Version)

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

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

Study Arms (4)

Breathing Training Group

EXPERIMENTAL

Participants 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.

Behavioral: Breathing Training

Cadence Exercise Group

EXPERIMENTAL

Participants 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.

Behavioral: Cadence Exercise

Combined Breathing Training + Cadence Exercise Group

EXPERIMENTAL

Participants 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.

Behavioral: Breathing Training; Behavioral: Cadence Exercise

Usual Care Group

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Breathing Training BEHAVIORAL

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.

Breathing Training Group; Combined Breathing Training + Cadence Exercise Group

Cadence Exercise BEHAVIORAL

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.

Cadence Exercise Group; Combined Breathing Training + Cadence Exercise Group

Usual Care OTHER

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.

Usual Care Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fu Jen Catholic University Hospital: lead

Study Sites (2)

Fu Jen Catholic University Hospital

New Taipei City, New Taipei City, 242062, Taiwan

NOT YET RECRUITING

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, New Taipei City, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 39175447 BACKGROUND

• 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.

  PMID: 38205730 BACKGROUND

• 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.

  PMID: 36028881 BACKGROUND

• 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.

  PMID: 33574969 BACKGROUND

• 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.

  PMID: 36606682 BACKGROUND

Related Links

• Early comprehensive pulmonary rehabilitation for hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial
• 2025 GOLD Report: Global Strategy for Prevention, Diagnosis and Management of COPD

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Breathing Exercises

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)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• CHIA JUNG CHANG, RN

  Fu Jen Catholic University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHIA JUNG CHANG, RN

CONTACT

+886929228555; jamine970807@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to participants' group assignments. Participants and intervention providers cannot be blinded because of the nature of the behavioral and exercise interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Head Nurse

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 6, 2026
• Study Start: October 6, 2026
• Primary Completion (Estimated): December 25, 2027
• Study Completion (Estimated): December 25, 2027
• Last Updated: October 6, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)