Effects of a Long-term Home-based Exercise Training Program Using Minimal Equipment vs Usual Care in COPD Patients: A Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
Study Overview
Brief Summary
The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who did not participate in an inpatient or outpatient rehabilitation program within the last 2 years.
Detailed Description
Exercise training is an important component of pulmonary rehabilitation (PR) the management of chronic obstructive pulmonary disease (COPD) and numerous trials have shown large improvements in health-related quality of life (HRQoL) and exercise capacity in persons with COPD. However, the great majority of patients who would benefit from PR never follow such a program. Moreover, many COPD patients are either not instructed to exercise at all or fail to adhere to exercise training at home after completing PR.
This study evaluates a newly developed exercise training program that requires minimal equipment (i.e., only a chair and elastic bands) and can be easily implemented long-term in the patient's home-setting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent after being informed
- •Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC)<70% predicted, FEV1<80 % predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a GOLD stage II-IV
- •No participation in an inpatient or outpatient pulmonary rehabilitation within the last 12 months
- •Male and female patients ≥40 years of age
- •Knowledge of German language to understand study material and assessments
Exclusion Criteria
- •Patients not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations.
- •Planned participation in a pulmonary rehabilitation program
Arms & Interventions
Exercise intervention
Home-based, minimal equipment exercise training program.
Intervention: Exercise (Behavioral)
Control
Usual care (study participation does not have any impact on regular treatment decisions, including participation in other exercise training programs).
Outcomes
Primary Outcomes
Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
Time Frame: Change from baseline to 12 months
Dyspnea domain of the CRQ; 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea)
Secondary Outcomes
- Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test)(Change from baseline to 12 months)
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline to 12 months)
- Symptoms (COPD Assessment Test; CAT)(Change from baseline to 12 months)
- Health status (Feeling Thermometer; FT)(Change from baseline to 12 months)
- Health-related quality of life (EuroQOL; EQ-5D-5L)(Change from baseline to 12 months)
- Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)(Change from baseline to 3, 6 and 12 months)
- Functional exercise capacity (Six-Minute Walk Test; 6MWT)(Change from baseline to 12 months)
- Health-related quality of life (Chronic Respiratory Questionnaire; CRQ)(Change from baseline to 12 months)
- Physical activity (PROactive physical activity in COPD instrument, clinical visit version; C-PPAC; domains amount and difficulty)(Change from baseline to 12 months, measured during 1 week prior to the visits)
- Exacerbations of COPD (event based, patient reported)(During the entire study, assessed at 3, 6 and 12 months)