Effects of Ergometer Training With Telemonitoring in Patients With Chronic Obstructive Pulmonary Disease (COPD) After Exacerbation

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Ergometer Training; Other: Motivation

• Registration Number: NCT01987544
• Lead Sponsor: Institut für Pneumologie Hagen Ambrock eV

Brief Summary

Home ergometer training combined with online monitoring and regular telephone support could prove to be a cost-effective method to improve physical performance and quality of life in COPD patients.

The primary objective of the study is to demonstrate a significantly higher daily workout time in patients that are monitored during home ergometer training with telephone support compared to conventional home ergometer training. Consequently we expect an increased quality of life related to the illness and a decreasing BODE-Index. A post-interventional lower BODE-Index correlates with a reduced risk of hospitalisation and mortality.

Detailed Description

Hypothesis: There will be an increased prevalence, morbidity and mortality of COPD during the next decades. On the other hand there is a clear correlation between life expectancy and physical activity in this disease. Telemedicine concepts promise new treatment strategies with favourable impact on the long-term process of COPD.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-19
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-24
• Last Update Posted: 2016-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• COPD

Exclusion Criteria

• tumor diseases
• unstable coronary heart disease
• untreated cardiac valve disease
• incapable of giving consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Self-Control	Ergometer Training	3 months of ergometer training under self control at home without any interventional motivation.
Motivation	Ergometer Training	3 months of ergometer training at home with telemonitoring and motivation phone calls once a week when training sessions drop below 20 minutes per day.
Motivation	Motivation	3 months of ergometer training at home with telemonitoring and motivation phone calls once a week when training sessions drop below 20 minutes per day.

Primary Outcome Measures

Name	Time	Method
Training time	3 month	Patients workout at home with a provided bicycle ergometer, the daily training target is 30 minutes. The training time is monitored online using a GSM module.

Secondary Outcome Measures

Name	Time	Method
BODE-Index	3 month	The BODE-Index is a grading tool to assess the progress of COPD with a range of 0 to 10 points. A post-interventional lower BODE-Index correlates with a reduced risk of hospitalisation and mortality.

Trial Locations

Locations (1)

Helios Klinik Hagen; 🇩🇪 Hagen, NRW, Germany