Ergometer Training in Patients With OSA

This study has been completed.
Sponsor:
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

October 20, 2011
September 17, 2012
February 2011
November 2011   (final data collection date for primary outcome measure)
Training time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01457729 on ClinicalTrials.gov Archive Site
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Ergometer Training in Patients With OSA
Telemedizinisches Trainings-Monitoring Von Patienten Mit Obstruktivem Schlafapnoesyndrom

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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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
Behavioral: Motivation by Telephone Call
Telephone call not exceeding 10 minutes according to a protocol
  • No Intervention: No Motivation
    Patients are asked to complete a telemonitored Ergometer training for 4 Weeks, at least 30 minutes per day, no more intervention is done.
  • Motivation
    Patients are asked to complete a telemonitored Ergometer training for 4 Weeks, at least 30 minutes every day. If training time declines to less than 20 minutes per day for one week, a motivation phone call will take place once a week.
    Intervention: Behavioral: Motivation by Telephone Call
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Suspected OSA
  2. Capable of giving consent

Exclusion Criteria:

  1. Symptomatic cardial infarction
  2. Decompensated cardiac insufficiency
  3. Hemodynamically effective cardiac arrhythmias
  4. Hemodynamically significant Vitia (heart disease)
  5. Insufficiently regulated arterial hypertension
  6. Global respiratory insufficiency
  7. Significant partial insufficiency (PAO2 <50mmHg or SaO2 < 80% at rest)
  8. State after decompensation of Cor Pulmonale
  9. Right ventricular strain at pulmonary hypertension at rest (pulmonary arterial pressure > 20 mmHg)
  10. Severe osteoporosis
  11. Higher degree of lung functional restriction: FEV1 <50% oder >60% of nominal value after bronchospasmolysis
  12. Working performance on ergometer < 50%
  13. Unstable bronchial asthma
  14. Exacerbated COPD
  15. Heavily overweight (BMI >40 or weight >140kg)
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01457729
ERGO2011
No
Institut für Pneumologie Hagen Ambrock eV
Institut für Pneumologie Hagen Ambrock eV
Not Provided
Principal Investigator: Karl Heinz Ruehle, Prof Institut für Pneumologie Hagen Ambrock eV
Institut für Pneumologie Hagen Ambrock eV
September 2012

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