Ergometer Training in Patients With OSA | NCT01457729

Studies
Ergometer Training in Patients With OSA

NCT01457729

Sponsor

Institut für Pneumologie Hagen Ambrock eV

Status

Completed

Last Update Posted

Sep 18, 2012Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Motivation by Telephone Call

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Oct 20, 2011

First Submission Date that Met QC Criteria

Oct 20, 2011

First Posted Date

Oct 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2012

Last Update Posted Date

Sep 18, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Motivation by Telephone Call	Behavioral	Telephone call not exceeding 10 minutes according to a protocol	Motivation

Measure	Description	Time Frame
Training time		4 weeks

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl Heinz Ruehle, Prof	Institut für Pneumologie Hagen Ambrock eV	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helios Klinik Hagen Ambrock		Hagen	North Rhine-Westphalia	58091	Germany

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

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