Ergometer Training in Patients With OSA

NCT01457729 | Completed

• 1 other identifier: ERGO2011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

ergometer; training; motivation; telemonitoring; sleep apnea

Outcome Measures

Primary Outcomes (1)

• Training time

  4 weeks

Study Arms (2)

No Motivation

NO INTERVENTION

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

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

Interventions

Motivation by Telephone Call BEHAVIORAL

Telephone call not exceeding 10 minutes according to a protocol

Motivation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected OSA
• Capable of giving consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead

Study Sites (1)

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Karl Heinz Ruehle, Prof

  Institut für Pneumologie Hagen Ambrock eV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 24, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 18, 2012

Record last verified: 2012-09

Locations

DE (1)