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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Motivation by Telephone Call

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Hagen, NRW, Germany, 58091
      • Helios Klinik Hagen Ambrock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Training time	4 weeks

Collaborators and Investigators

• Sponsor: Institut für Pneumologie Hagen Ambrock eV
• Investigators: Principal Investigator: Karl Heinz Ruehle, Prof, Institut für Pneumologie Hagen Ambrock eV

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 20, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 24, 2011

Study Record Updates

• Last Update Posted (Estimate): September 18, 2012
• Last Update Submitted That Met QC Criteria: September 17, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: training; ergometer; sleep apnea; telemonitoring; motivation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: ERGO2011