Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment Phase
COPD Other: Ergometer Training Other: Motivation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: German: Effekte Eines Telemonitorisch überwachten Ergometertrainings Bei Patienten Mit Einer COPD Nach Exazerbation: Eine Prospektiv Randomisierte Studie
Study Start Date : September 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Active Comparator: Self-Control
3 months of ergometer training under self control at home without any interventional motivation.
Other: Ergometer Training
Other Name: Ergometer

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.
Other: Ergometer Training
Other Name: Ergometer

Other: Motivation
Other Names:
  • Telemonitoring
  • Phone Calls




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987544


Locations
Layout table for location information
Germany
Helios Klinik Hagen
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
Vitaphone GmbH
Layout table for additonal information
Responsible Party: Karl Josef Franke, Senior Physician Helios Klinik Hagen, Klinik für Pneumologie, Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier: NCT01987544    
Other Study ID Numbers: Telebike2013
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Keywords provided by Karl Josef Franke, Institut für Pneumologie Hagen Ambrock eV:
COPD
telemonitoring
training
ergometer
telemedicine