Home-based Exercise Training for COPD Patients (HOMEX-2)

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 did not participate in an inpatient or outpatient rehabilitation program within the last 2 years.

Detailed Description
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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.

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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Lung Diseases, Obstructive, Chronic Disease, 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 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

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 decisions, including participation in other exercise training programs). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Hospital Anxiety and Depression Scale (HADS) | Symptoms of depression and anxiety (14 questions, 4-point Likert-type scale) | Change from baseline to 12 months | 
| 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 | 
| 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 | 
| 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 | 

 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, Exercise training intervention, Randomized controlled trial