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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987544
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : February 25, 2016
Sponsor:
Collaborator:
Vitaphone GmbH
Information provided by (Responsible Party):
Karl Josef Franke, Institut für Pneumologie Hagen Ambrock eV

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 19, 2013
Last Update Posted Date February 25, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Training time [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
BODE-Index [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 18, 2013)
CAT (COPD Assessment Test) [ Time Frame: 3 month ]
The CAT is a questionnaire to measure the impact of COPD on a person's life. The range is 0 to 40 points.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Ergometer Training With Telemonitoring in Patients With Chronic Obstructive Pulmonary Disease (COPD) After Exacerbation
Official Title  ICMJE German: Effekte Eines Telemonitorisch überwachten Ergometertrainings Bei Patienten Mit Einer COPD Nach Exazerbation: Eine Prospektiv Randomisierte Studie
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE
  • Other: Ergometer Training
    Other Name: Ergometer
  • Other: Motivation
    Other Names:
    • Telemonitoring
    • Phone Calls
Study Arms  ICMJE
  • Active Comparator: Self-Control
    3 months of ergometer training under self control at home without any interventional motivation.
    Intervention: Other: Ergometer Training
  • Experimental: 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.
    Interventions:
    • Other: Ergometer Training
    • Other: Motivation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2016)
53
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
50
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • COPD

Exclusion Criteria:

  • tumor diseases
  • unstable coronary heart disease
  • untreated cardiac valve disease
  • incapable of giving consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01987544
Other Study ID Numbers  ICMJE Telebike2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karl Josef Franke, Institut für Pneumologie Hagen Ambrock eV
Study Sponsor  ICMJE Institut für Pneumologie Hagen Ambrock eV
Collaborators  ICMJE Vitaphone GmbH
Investigators  ICMJE Not Provided
PRS Account Institut für Pneumologie Hagen Ambrock eV
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP