NCT00968448

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 5, 2011

Status Verified

August 1, 2009

Enrollment Period

1.4 years

First QC Date

August 28, 2009

Last Update Submit

January 4, 2011

Conditions

Running Endurance

Keywords

respiratory musclebreathing patternexercise performance

Outcome Measures

Primary Outcomes (1)

  • performance in the 500m run time trial

    6-8 weeks

Secondary Outcomes (1)

  • maximum inspiratory pressure

    6-8- weeks

Study Arms (2)

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

Respiratory muscle trainingBEHAVIORAL

Daily training with a handheld device (Pressure threshold loading). 1x50 breaths with adjustments (gradually increasing levels).

Training
Sham trainingBEHAVIORAL

Sham training with same handheld device. 50 breaths daily on the lowest level

sham training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • well trained runners

You may not qualify if:

  • previous respiratory muscle training
  • cardiovascular diseases
  • impaired lung function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universität des Saarlands

Saarbrücken, Saarland, 66123, Germany

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Ulf Such, MD

    Institute for Sports Medicine and Prevention / Saarland Universitiy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 5, 2011

Record last verified: 2009-08

Locations

DE(1)