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Ergometer Training in Patients With OSA

I

Institut für Pneumologie Hagen Ambrock eV

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Behavioral: Motivation by Telephone Call

Study type

Interventional

Funder types

Industry

Identifiers

NCT01457729
ERGO2011

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

No Motivation
No Intervention group
Description:
Patients are asked to complete a telemonitored Ergometer training for 4 Weeks, at least 30 minutes per day, no more intervention is done.
Motivation
Other group
Description:
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.
Treatment:
Behavioral: Motivation by Telephone Call

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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