Effects of TPB-Based Cadence Exercise and Breathing Training on Physiological Parameters and Quality of Life in Patients With COPD (COPD)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: CHIA JUNG CHANG, RN
- Número de teléfono: +886929228555
- Correo electrónico: jamine970807@gmail.com
Ubicaciones de estudio
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New Taipei City
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New Taipei City, New Taipei City, Taiwán, 242062
- Aún no reclutando
- Fu Jen Catholic University Hospital
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Contacto:
- CHIA JUNG CHANG, RN
- Número de teléfono: +886929228555
- Correo electrónico: jamine970807@gmail.com
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New Taipei City, New Taipei City, Taiwán
- Reclutamiento
- Taipei Hospital, Ministry of Health and Welfare
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Contacto:
- CHIA JUNG CHANG, RN
- Número de teléfono: *886929228555
- Correo electrónico: jamine970807@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
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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.
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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. |
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. |
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Experimental: 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. |
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. |
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Experimental: 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. |
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. 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. |
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Comparador activo: 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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximal Inspiratory Pressure (MIP)
Periodo de tiempo: Baseline (T0), Week 8 (T1), and Week 12 (T2)
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Maximal inspiratory pressure (MIP) will be measured to evaluate respiratory muscle strength. |
Baseline (T0), Week 8 (T1), and Week 12 (T2)
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Maximal Expiratory Pressure (MEP)
Periodo de tiempo: Baseline (T0), Week 8 (T1), and Week 12 (T2)
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Maximal expiratory pressure (MEP) will be measured to evaluate respiratory muscle strength. |
Baseline (T0), Week 8 (T1), and Week 12 (T2)
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Oxygen Saturation (SpO₂)
Periodo de tiempo: Baseline (T0), Week 8 (T1), and Week 12 (T2)
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Oxygen saturation (SpO₂) will be measured to evaluate physiological status. |
Baseline (T0), Week 8 (T1), and Week 12 (T2)
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Six-Minute Walk Test (6MWT)
Periodo de tiempo: Baseline (T0), Week 8 (T1), and Week 12 (T2)
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Six-minute walk test (6MWT) distance will be measured to evaluate exercise capacity. |
Baseline (T0), Week 8 (T1), and Week 12 (T2)
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COPD Assessment Test (CAT)
Periodo de tiempo: Baseline (T0), Week 8 (T1), and Week 12 (T2)
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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)
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Modified Medical Research Council Dyspnea Scale (mMRC)
Periodo de tiempo: Baseline (T0), Week 8 (T1), and Week 12 (T2)
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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)
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St. George's Respiratory Questionnaire (SGRQ)
Periodo de tiempo: Baseline (T0), Week 8 (T1), and Week 12 (T2)
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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)
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WHOQOL-BREF (Taiwan Version)
Periodo de tiempo: Baseline (T0), Week 8 (T1), and Week 12 (T2)
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WHOQOL-BREF (Taiwan Version) score will be used to assess health-related quality of life. |
Baseline (T0), Week 8 (T1), and Week 12 (T2)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: CHIA JUNG CHANG, RN, Fu Jen Catholic University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades Pulmonares Obstructivas
- Condiciones Patológicas, Signos y Síntomas
- Enfermedad Pulmonar Obstructiva Crónica
- Terapéutica
- Terapias de la mente-cuerpo
- Terapias complementarias
- Técnicas de movimiento del ejercicio
- Modalidades de fisioterapia
- Ejercicios de respiración
Otros números de identificación del estudio
- FJUH115606
- FJUH115606 (Otro identificador: Fu Jen Catholic University Hospital, Fu Jen Catholic University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
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