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

5 oktober 2026 bijgewerkt door: CHANG CHIA JUNG, Fu Jen Catholic University Hospital

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Taiwan
    • New Taipei City
      • New Taipei City, New Taipei City, Taiwan, 242062
        • Nog niet aan het werven
        • Fu Jen Catholic University Hospital
        • Contact:
      • New Taipei City, New Taipei City, Taiwan
        • Werving
        • Taipei Hospital, Ministry of Health and Welfare
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Breathing Training Group

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.
Gedragsmatig: Breathing Training

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.
Experimenteel: Cadence Exercise Group

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.
Gedragsmatig: Cadence Exercise

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.
Experimenteel: Combined Breathing Training + Cadence Exercise Group

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.
Gedragsmatig: Breathing Training

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.

Gedragsmatig: Cadence Exercise

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.
Actieve vergelijker: Usual Care Group

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.
Ander: Usual Care

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximal Inspiratory Pressure (MIP)
Tijdsspanne: Baseline (T0), Week 8 (T1), and Week 12 (T2)

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

Maximal expiratory pressure (MEP) will be measured to evaluate respiratory muscle strength.
Baseline (T0), Week 8 (T1), and Week 12 (T2)
Oxygen Saturation (SpO₂)
Tijdsspanne: Baseline (T0), Week 8 (T1), and Week 12 (T2)

Oxygen saturation (SpO₂) will be measured to evaluate physiological status.
Baseline (T0), Week 8 (T1), and Week 12 (T2)
Six-Minute Walk Test (6MWT)
Tijdsspanne: Baseline (T0), Week 8 (T1), and Week 12 (T2)

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

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

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

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

WHOQOL-BREF (Taiwan Version) score will be used to assess health-related quality of life.
Baseline (T0), Week 8 (T1), and Week 12 (T2)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fu Jen Catholic University Hospital

Onderzoekers

  • Hoofdonderzoeker: CHIA JUNG CHANG, RN, Fu Jen Catholic University Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

6 oktober 2026

Primaire voltooiing (Geschat)

25 december 2027

Studie voltooiing (Geschat)

25 december 2027

Studieregistratiedata

Eerst ingediend

30 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 oktober 2026

Eerst geplaatst (Werkelijk)

6 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

5 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FJUH115606
  • FJUH115606 (Andere identificatie: Fu Jen Catholic University Hospital, Fu Jen Catholic University)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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