Effects of a Long-term Home-based Exercise Training Program Using Minimal Equipment vs Usual Care in COPD Patients: A Multicenter Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Disease
- Sponsor
- University of Zurich
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
- Status
- Completed
- Last Updated
- 4 years ago
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.
Investigators
Eligibility Criteria
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
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)