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
| Registry | NCT07860008, acronym COPD |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 200 (Estimated) |
| Sponsor | Fu Jen Catholic University Hospital (Other) |
| Conditions | Chronic Obstructive Pulmonary Disease |
| Interventions | Breathing Training, Cadence Exercise, Usual Care (Behavioral, other) |
| Dates | start 2026-10-06 (estimated), primary completion 2027-12-25 (estimated), completion 2027-12-25 (estimated), first posted 2026-10-06, last updated 2026-10-06 |
| Locations | 2 sites in Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Obstructive Pulmonary Disease All trials of Breathing Training All trials of Cadence Exercise
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Breathing Training Group | Experimental | Behavioral: Breathing Training | 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. |
| Cadence Exercise Group | Experimental | Behavioral: Cadence Exercise | 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. |
| Combined Breathing Training + Cadence Exercise Group | Experimental | Behavioral: Breathing Training; Behavioral: Cadence Exercise | 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. |
| Usual Care Group | Active comparator | Other: 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. |
Sex: All, ages: 40 Years to any
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. \-
| Facility | City | Country | Status |
|---|---|---|---|
| Fu Jen Catholic University Hospital | New Taipei City, New Taipei City | Taiwan | Not yet recruiting |
| Taipei Hospital, Ministry of Health and Welfare | New Taipei City, New Taipei City | Taiwan | Recruiting |