Inspiratory Muscle Training (IMT) in Athletes | NCT00968448

Studies
Inspiratory Muscle Training (IMT) in Athletes

NCT00968448

Sponsor

Universität des Saarlandes

Status

Completed

Last Update Posted

Jan 5, 2011Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Running Endurance

Interventions

Respiratory muscle training
Sham training

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

Aug 2009

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

Aug 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Aug 28, 2009

First Submission Date that Met QC Criteria

Aug 28, 2009

First Posted Date

Aug 31, 2009Estimated

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

Jan 4, 2011

Last Update Posted Date

Jan 5, 2011Estimated

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

The purpose of this study is to determine weather well trained athletes benefit from inspiratory (respiratory) muscle training.

Detailed Description

Subject: The investigators intend to include 40 well trained runners, 18 years or older.
Design: Following lung function and exercise testing (incremental treadmill test to exhaustion, 5000m run time trial) participants will be randomly assigned to a verum or a control group. The verum group will train with a hand-held, commercially available pressure threshold loading device (POWERbreathe,UK). The control group will perform a sham-training with the same device. After six to eight weeks the the initial tests will be repeated.
Hypothesis: Inspiratory muscle training enhances performance on submaximal work loads and in the 5000m run time trial by changes in breathing pattern. Maximum oxygen uptake remains unchanged.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training	Active Comparator	respiratory muscle training (pressure threshold loading)	Behavioral: Respiratory muscle training
sham training	Sham Comparator	training with low resistance	Behavioral: Sham training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Respiratory muscle training	Behavioral	Daily training with a handheld device (Pressure threshold loading). 1x50 breaths with adjustments (gradually increasing levels).	Training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
performance in the 500m run time trial		6-8 weeks

Secondary Outcomes

Measure	Description	Time Frame
maximum inspiratory pressure		6-8- weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

well trained runners

Exclusion Criteria:

previous respiratory muscle training
cardiovascular diseases
impaired lung function

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulf Such, MD	Institute for Sports Medicine and Prevention / Saarland Universitiy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universität des Saarlands		Saarbrücken	Saarland	66123	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D001945	Breathing Exercises

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026241	Exercise Movement Techniques

Browse Leaves

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Browse Branches

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