Home-based Exercise Training for COPD Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Long-term Home-based Exercise Training Program Using Minimal Equipment vs. Usual Care in COPD Patients: a Multicenter Randomized Controlled Trial

Conditions
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Chronic Disease, Lung Diseases, Obstructive, Respiratory Disease

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br>Home-based, minimal equipment exercise training program. | Behavioral: Exercise<br>* 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.<br>|
| No Intervention: Control<br>Usual care (study participation does not have any impact on regular treatment or treatment decisions, including participation in other exercise training programs or rehabilitation programs) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | 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) | Change from baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | 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) | Change from baseline to 3, 6 and 12 months | 
| Exercise capacity | Six-Minute Walk Test (walk distance) and 1-min Sit-to-Stand Test (number of repetitions) | Change from baseline to 12 months | 
| Health-related quality of life | 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 | Change from baseline to 12 months | 
| Health status | Visual analogue scale Feeling thermometer (0-100 scale; 0= worst health you can imagine; 100=best health you can imagine) | Change from baseline to 12 months | 
| Exacerbations | Event based, patient reported | During entire study, assessed at 12 months | 
| Symptoms | Questionnaire, COPD Assessment Test | Change from baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, minimal equipment, home-based, COPD