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
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Behavioral: Motivation by Telephone Call

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telemedizinisches Trainings-Monitoring Von Patienten Mit Obstruktivem Schlafapnoesyndrom

Resource links provided by NLM:


Further study details as provided by Institut für Pneumologie Hagen Ambrock eV:

Primary Outcome Measures:
  • Training time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Motivation by Telephone Call
Telephone call not exceeding 10 minutes according to a protocol

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457729

Locations
Germany
Helios Klinik Hagen Ambrock
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
Investigators
Principal Investigator: Karl Heinz Ruehle, Prof Institut für Pneumologie Hagen Ambrock eV
  More Information

No publications provided

Responsible Party: Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier: NCT01457729     History of Changes
Other Study ID Numbers: ERGO2011
Study First Received: October 20, 2011
Last Updated: September 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut für Pneumologie Hagen Ambrock eV:
ergometer
training
motivation
telemonitoring
sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014