Effects of Ergometer Training With Telemonitoring in Patients With Chronic Obstructive Pulmonary Disease (COPD) After Exacerbation
COPD
German: Effekte Eines Telemonitorisch überwachten Ergometertrainings Bei Patienten Mit Einer COPD Nach Exazerbation: Eine Prospektiv Randomisierte Studie
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 13, 2013
CompletedFirst Posted
Study publicly available on registry
November 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFebruary 25, 2016
February 1, 2016
2.2 years
November 13, 2013
February 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Training time
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.
3 month
Secondary Outcomes (1)
BODE-Index
3 month
Other Outcomes (1)
CAT (COPD Assessment Test)
3 month
Study Arms (2)
Self-Control
ACTIVE COMPARATOR3 months of ergometer training under self control at home without any interventional motivation.
Motivation
EXPERIMENTAL3 months of ergometer training at home with telemonitoring and motivation phone calls once a week when training sessions drop below 20 minutes per day.
Interventions
Eligibility Criteria
You may qualify if:
- COPD
You may not qualify if:
- tumor diseases
- unstable coronary heart disease
- untreated cardiac valve disease
- incapable of giving consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut für Pneumologie Hagen Ambrock eVlead
- Vitaphone GmbHcollaborator
Study Sites (1)
Helios Klinik Hagen
Hagen, North Rhine-Westphalia, 58091, Germany
Related Publications (1)
Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
PMID: 33511633DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Physician Helios Klinik Hagen, Klinik für Pneumologie
Study Record Dates
First Submitted
November 13, 2013
First Posted
November 19, 2013
Study Start
September 1, 2012
Primary Completion
December 1, 2014
Study Completion
March 1, 2015
Last Updated
February 25, 2016
Record last verified: 2016-02