Clinical trial NCT03461887: Home-based Exercise Training for COPD Patients
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
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 123
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 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.

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
* 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.

Primary outcomes:
measure: Dyspnea
timeFrame: Change from baseline to 12 months
Secondary outcomes:
measure: Dyspnea
timeFrame: Change from baseline to 3, 6 and 12 months
measure: Exercise capacity
timeFrame: Change from baseline to 12 months
measure: Health-related quality of life
timeFrame: Change from baseline to 12 months
measure: Health status
timeFrame: Change from baseline to 12 months
measure: Exacerbations
timeFrame: During entire study, assessed at 12 months
measure: Symptoms
timeFrame: Change from baseline to 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
timeFrame: From baseline to 12 months
measure: Experience with the exercise training program
timeFrame: From baseline to 12 months (assessed at 12 months)
measure: Health professionals' feedback
timeFrame: Assessed at 12 months
measure: Cost effectiveness
timeFrame: From baseline to 12 months (assessed at 3, 6, 12 months)
Locations:
city: Barmelweid
country: Switzerland
facility: Klinik Barmelweid
city: Heiligenschwendi
country: Switzerland
facility: Berner Reha Zentrum AG
city: Wald
country: Switzerland
facility: Zürcher RehaZentren Wald
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References:
citation: Frei A, Radtke T, Dalla Lana K, Brun P, Sigrist T, Spielmanns M, Beyer S, Riegler TF, Busching G, Spielmanns S, Kunz R, Cerini T, Braun J, Tomonaga Y, Serra-Burriel M, Polhemus A, Puhan MA. Effectiveness of a Long-term Home-Based Exercise Training Program in Patients With COPD After Pulmonary Rehabilitation: A Multicenter Randomized Controlled Trial. Chest. 2022 Dec;162(6):1277-1286. doi: 10.1016/j.chest.2022.07.026. Epub 2022 Aug 8.
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.