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Clinical Trials/NCT03461887
NCT03461887
Completed
N/A

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

University of Zurich5 sites in 1 country123 target enrollmentJanuary 24, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
University of Zurich
Enrollment
123
Locations
5
Primary Endpoint
Dyspnea
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 24, 2018
End Date
September 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Dyspnea

Time Frame: 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 Outcomes

  • Exacerbations(During entire study, assessed at 12 months)
  • Symptoms(Change from baseline to 12 months)
  • Dyspnea(Change from baseline to 3, 6 and 12 months)
  • Exercise capacity(Change from baseline to 12 months)
  • Health-related quality of life(Change from baseline to 12 months)
  • Health status(Change from baseline to 12 months)

Study Sites (5)

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