Home-based Exercise Training for COPD Patients

Not Applicable

Completed

• Conditions: Chronic Disease; Respiratory Disease; Lung Diseases, Obstructive
• Interventions: Behavioral: Exercise

• Registration Number: NCT03461887
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2018-01-24
• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-12
• Primary Completion: 2020-03-20
• Study Completion: 2021-09-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise intervention	Exercise	Home-based, minimal equipment exercise training program.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Exacerbations	During entire study, assessed at 12 months	Event based, patient reported
Symptoms	Change from baseline to 12 months	Questionnaire, COPD Assessment Test
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)
Exercise capacity	Change from baseline to 12 months	Six-Minute Walk Test (walk distance) and; 1-min Sit-to-Stand Test (number of repetitions)
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")

Trial Locations

Locations (5)

University of Zurich; 🇨🇭 Zurich, Switzerland

Klinik Barmelweid; 🇨🇭 Barmelweid, Switzerland

Zürcher RehaZentren Wald; 🇨🇭 Wald, Switzerland

Berner Reha Zentrum AG; 🇨🇭 Heiligenschwendi, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland