Clinical trial NCT03654092: Home-based Exercise Training for COPD Patients (HOMEX-2)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Lung Diseases, Obstructive
Respiratory Disease
Keywords: Exercise
Minimal equipment
Home-based
COPD
Exercise training intervention
Randomized controlled trial
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
timeFrame: Change from baseline to 12 months
Secondary outcomes:
measure: Dyspnea (Chronic Respiratory Questionnaire (CRQ) domain)
timeFrame: Change from baseline to 3, 6 and 12 months
measure: Functional exercise capacity (Six-Minute Walk Test; 6MWT)
timeFrame: Change from baseline to 12 months
measure: Functional exercise capacity (1-min Sit-to-Stand test; 1-min-STS test)
timeFrame: Change from baseline to 12 months
measure: Health-related quality of life (Chronic Respiratory Questionnaire; CRQ)
timeFrame: Change from baseline to 12 months
measure: Physical activity (PROactive physical activity in COPD instrument, clinical visit version; C-PPAC; domains amount and difficulty)
timeFrame: Change from baseline to 12 months, measured during 1 week prior to the visits
measure: Symptoms (COPD Assessment Test; CAT)
timeFrame: Change from baseline to 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline to 12 months
measure: Health status (Feeling Thermometer; FT)
timeFrame: Change from baseline to 12 months
measure: Health-related quality of life (EuroQOL; EQ-5D-5L)
timeFrame: Change from baseline to 12 months
measure: Exacerbations of COPD (event based, patient reported)
timeFrame: During the entire study, assessed at 3, 6 and 12 months
Other outcomes:
measure: Compliance to the exercise training program
timeFrame: Assessed daily by intervention group participants during 12 months
measure: Satisfaction with the exercise training program (self-developed questionnaire)
timeFrame: From baseline to 12 months, assessed at 12 months
measure: Experience with the exercise training program of the participants
timeFrame: From baseline to 12 months, assessed at 12 months
measure: Experience with the exercise training program of the health professionals
timeFrame: From baseline to 12 months, assessed at 12 months
measure: Cost effectiveness
timeFrame: From baseline to 12 months, assessed at 3, 6 and 12 months
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
citation: Frei A, Radtke T, Dalla Lana K, Braun J, Muller RM, Puhan MA. Effects of a long-term home-based exercise training programme using minimal equipment vs. usual care in COPD patients: a study protocol for two multicentre randomised controlled trials (HOMEX-1 and HOMEX-2 trials). BMC Pulm Med. 2019 Mar 1;19(1):57. doi: 10.1186/s12890-019-0817-7.