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Ergometer Training in Patients With OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Motivation by Telephone Call
Sponsored by
Institut für Pneumologie Hagen Ambrock eV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring ergometer, training, motivation, telemonitoring, sleep apnea

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Helios Klinik Hagen Ambrock

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

No Motivation

Motivation

Arm Description

Patients are asked to complete a telemonitored Ergometer training for 4 Weeks, at least 30 minutes per day, no more intervention is done.

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.

Outcomes

Primary Outcome Measures

Training time

Secondary Outcome Measures

Full Information

First Posted
October 20, 2011
Last Updated
September 17, 2012
Sponsor
Institut für Pneumologie Hagen Ambrock eV
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1. Study Identification

Unique Protocol Identification Number
NCT01457729
Brief Title
Ergometer Training in Patients With OSA
Official Title
Telemedizinisches Trainings-Monitoring Von Patienten Mit Obstruktivem Schlafapnoesyndrom
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
ergometer, training, motivation, telemonitoring, sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Motivation
Arm Type
No Intervention
Arm Description
Patients are asked to complete a telemonitored Ergometer training for 4 Weeks, at least 30 minutes per day, no more intervention is done.
Arm Title
Motivation
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Motivation by Telephone Call
Intervention Description
Telephone call not exceeding 10 minutes according to a protocol
Primary Outcome Measure Information:
Title
Training time
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected OSA Capable of giving consent Exclusion Criteria: Symptomatic cardial infarction Decompensated cardiac insufficiency Hemodynamically effective cardiac arrhythmias Hemodynamically significant Vitia (heart disease) Insufficiently regulated arterial hypertension Global respiratory insufficiency Significant partial insufficiency (PAO2 <50mmHg or SaO2 < 80% at rest) State after decompensation of Cor Pulmonale Right ventricular strain at pulmonary hypertension at rest (pulmonary arterial pressure > 20 mmHg) Severe osteoporosis Higher degree of lung functional restriction: FEV1 <50% oder >60% of nominal value after bronchospasmolysis Working performance on ergometer < 50% Unstable bronchial asthma Exacerbated COPD Heavily overweight (BMI >40 or weight >140kg)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Heinz Ruehle, Prof
Organizational Affiliation
Institut für Pneumologie Hagen Ambrock eV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinik Hagen Ambrock
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany

12. IPD Sharing Statement

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Ergometer Training in Patients With OSA

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