We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ergometer Training in Patients With OSA

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01457729
First Posted: October 24, 2011
Last Update Posted: September 18, 2012
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.
Information provided by (Responsible Party):
Institut für Pneumologie Hagen Ambrock eV
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

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.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier: NCT01457729     History of Changes
Other Study ID Numbers: ERGO2011
First Submitted: October 20, 2011
First Posted: October 24, 2011
Last Update Posted: September 18, 2012
Last Verified: September 2012

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 Wake Disorders
Nervous System Diseases