Chronic Disease, Lung Diseases, Obstructive, Respiratory Disease
Conditions
Keywords
exercise, minimal equipment, home-based, COPD
Brief summary
The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who have completed a pulmonary rehabilitation.
Detailed description
Exercise training is an important component of 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 pulmonary rehabilitation (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 pulmonary rehabilitation. This study evaluates an 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.
Interventions
BEHAVIORALExercise
Home-based exercise training program that requires only minimal equipment, and is individually adaptable to the participant's exercise level (6 times per week; 15-20 min; 38 exercise cards and one interactive training agenda booklet). After randomization, a health care professional (HOMEX coach) will visit the intervention group participants at their home to set up the training location, to instruct the exercises and to establish individualized goals. Follow-up visits are planned after 3 and 8-9 weeks. Regular telephone calls will be conducted by the same HOMEX coach to motivate the patients, to discuss training progress and concrete benefits and barriers, and to adapt goals and the training program. Additional intervention elements are that a relative or friend is involved as a sparring partner to support the participant. The general practitioner is informed about the participation of his/her patient in the intervention.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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 * Completion of an inpatient or outpatient pulmonary rehabilitation not longer than 1 months ago * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | Change from baseline to 12 months | Dyspnea domain of the Chronic Respiratory Questionnaire (CRQ); 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | Change from baseline to 12 months | Six-Minute Walk Test (walk distance) and 1-min Sit-to-Stand Test (number of repetitions) |
| Dyspnea | Change from baseline to 3, 6 and 12 months | Dyspnea domain of the Chronic Respiratory Questionnaire (CRQ); 5 questions; 7-point Likert-type scale ranging from 1 (most severe dyspnea) to 7 (no dyspnea) |
| Health-related quality of life | Change from baseline to 12 months | Chronic Respiratory Questionnaires (CRQ): Fatigue, emotional function, mastery domain and EuroQoL (EQ-5D-5L): 5 Dimensions - Mobility, self-care, usual activities, pain/discomfort, anxiety/depression including 1 item each with 5 levels |
| Health status | Change from baseline to 12 months | Visual analogue scale Feeling thermometer (0-100 scale; 0= worst health you can imagine; 100=best health you can imagine) |
| Exacerbations | During entire study, assessed at 12 months | Event based, patient reported |
| Symptoms | Change from baseline to 12 months | Questionnaire, COPD Assessment Test |
Other
| Measure | Time frame | Description |
|---|---|---|
| Experience with the exercise training program | From baseline to 12 months (assessed at 12 months) | Semi-structured interview |
| Health professionals' feedback | Assessed at 12 months | Semi-structured interview |
| Cost effectiveness | From baseline to 12 months (assessed at 3, 6, 12 months) | Questionnaire: cost per quality-adjusted life year |
| Satisfaction with the exercise training program | From baseline to 12 months | Questionnaire (Likert-Type scales) |
| Compliance to the exercise training program | Assessed daily by intervention group participants during 12 months | Percentage of fulfilled training sessions based on training diaries |
Countries
Switzerland
Outcome results
None listed