Ergometer Training in Patients With OSA
This study has been completed.
Sponsor:
Institut für Pneumologie Hagen Ambrock eV
Information provided by (Responsible Party):
Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier:
NCT01457729
First received: October 20, 2011
Last updated: September 17, 2012
Last verified: September 2012
| Tracking Information | |||||
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| First Received Date ICMJE | October 20, 2011 | ||||
| Last Updated Date | September 17, 2012 | ||||
| Start Date ICMJE | February 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Training time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01457729 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ergometer Training in Patients With OSA | ||||
| Official Title ICMJE | Telemedizinisches Trainings-Monitoring Von Patienten Mit Obstruktivem Schlafapnoesyndrom | ||||
| Brief Summary | Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard bike ergometer which is additionally equipped with a system to gather training data and the ability to send daily training time to an internet server to which the physician has access. Training time of two groups is compared. Group one is not motivated while group two benefits from telephone feedback when training time declines. It is presumed that training time increases with better information and response to training behaviour. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Obstructive Sleep Apnea | ||||
| Intervention ICMJE | Behavioral: Motivation by Telephone Call
Telephone call not exceeding 10 minutes according to a protocol |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 24 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01457729 | ||||
| Other Study ID Numbers ICMJE | ERGO2011 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Institut für Pneumologie Hagen Ambrock eV | ||||
| Study Sponsor ICMJE | Institut für Pneumologie Hagen Ambrock eV | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Institut für Pneumologie Hagen Ambrock eV | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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