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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Taiwan
    • New Taipei City
      • New Taipei City, New Taipei City, Taiwan, 242062
        • Har ikke rekruttert ennå
        • Fu Jen Catholic University Hospital
        • Ta kontakt med:
      • New Taipei City, New Taipei City, Taiwan
        • Rekruttering
        • Taipei Hospital, Ministry of Health and Welfare
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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.

Atferdsmessig: 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.
Aktiv komparator: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximal Inspiratory Pressure (MIP)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fu Jen Catholic University Hospital

Etterforskere

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

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

6. oktober 2026

Primær fullføring (Antatt)

25. desember 2027

Studiet fullført (Antatt)

25. desember 2027

Datoer for studieregistrering

Først innsendt

30. september 2026

Først innsendt som oppfylte QC-kriteriene

5. oktober 2026

Først lagt ut (Faktiske)

6. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FJUH115606
  • FJUH115606 (Annen identifikator: Fu Jen Catholic University Hospital, Fu Jen Catholic University)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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