Chronic Disease Clinical Trial
Official title:
Effects of a Long-term Home-based Exercise Training Program Using Minimal Equipment vs Usual Care in COPD Patients: A Multicenter Randomized Controlled Trial
Verified date | December 2021 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 15, 2021 |
Est. primary completion date | March 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Compliance to the exercise training program | Percentage of fulfilled training sessions based on training diaries | Assessed daily by intervention group participants during 12 months | |
Other | Satisfaction with the exercise training program (self-developed questionnaire) | Self-developed questionnaire assessing satisfaction with the intervention: 10 specific questions regarding elements of the intervention using Likert-type scales from 0=not useful at all to 10=very useful) and 4 global questions using Likert-type scales (from 0=worst outcome to 4=best outcome) | From baseline to 12 months, assessed at 12 months | |
Other | Experience with the exercise training program of the participants | Semi-structured interview and/or focus groups | From baseline to 12 months, assessed at 12 months | |
Other | Experience with the exercise training program of the health professionals | Semi-structured interview and/or focus groups | From baseline to 12 months, assessed at 12 months | |
Other | Cost effectiveness | Questionnaire: Cost per quality-adjusted life-year, direct healthcare costs, direct non-healthcare costs, indirect costs | From baseline to 12 months, assessed at 3, 6 and 12 months | |
Primary | Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain) | Dyspnea domain of the CRQ; 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea) | Change from baseline to 12 months | |
Secondary | Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain) | Dyspnea domain of the CRQ; 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea) | Change from baseline to 3, 6 and 12 months | |
Secondary | Functional exercise capacity (Six-Minute Walk Test; 6MWT) | Total distance in meters walked by the patient during timed six minutes. The 6MWT will be conducted twice (the better result will be used) and according to the American Thoracic Society (ATS) guidelines | Change from baseline to 12 months | |
Secondary | Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test) | The number of repetitions that the patient completes the full sit-to-stand movement from a standard chair (i.e. standing up from a chair and sitting down again) during one minute | Change from baseline to 12 months | |
Secondary | Health-related quality of life (Chronic Respiratory Questionnaire; CRQ) | Remaining domains of the CRQ (besides the dyspnea domain): Domains fatigue, emotional function and mastery. The total CRQ contains 20 questions responded to on a 7-point Likert-type scale, ranging from 1 to 7 with lower scores indicating worse HRQoL, loading on the domains dyspnea, fatigue, emotional and mastery | Change from baseline to 12 months | |
Secondary | Physical activity (PROactive physical activity in COPD instrument, clinical visit version; C-PPAC; domains amount and difficulty) | The C-PPAC is a validated and reliable hybrid tool combining a short patient-reported outcome questionnaire and two activity monitor variables (assessed by the accelerometer ActiGraph®) to measure physical activity in COPD patients in the two domains amount and difficulty (item scores 0-4, scale 0-100) | Change from baseline to 12 months, measured during 1 week prior to the visits | |
Secondary | Symptoms (COPD Assessment Test; CAT) | The CAT measures the impact of COPD on a person's health status (8 questions, 6-point Likert-type scale) | Change from baseline to 12 months | |
Secondary | Hospital Anxiety and Depression Scale (HADS) | Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale) | Change from baseline to 12 months | |
Secondary | Health status (Feeling Thermometer; FT) | The FT is a visual analogue scale for overall health state ranging from 0 (worst health you can imagine) to 100 (best healthy you can imagine) | Change from baseline to 12 months | |
Secondary | Health-related quality of life (EuroQOL; EQ-5D-5L) | The EQ-5D-5L assesses the 5 dimensions mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item with 5 levels each | Change from baseline to 12 months | |
Secondary | Exacerbations of COPD (event based, patient reported) | The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics | During the entire study, assessed at 3, 6 and 12 months |
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