Running EnduranceNCT00968448
Inspiratory Muscle Training (IMT) in Athletes
A study testing Respiratory muscle training in people with Running Endurance, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
The purpose of this study is to determine weather well trained athletes benefit from inspiratory (respiratory) muscle training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Running Endurance
- What is being tested?
- Respiratory muscle training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- well trained runners
Who cannot join
- previous respiratory muscle training
- cardiovascular diseases
- impaired lung function
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine weather well trained athletes benefit from inspiratory (respiratory) muscle training.
Read the 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.
- Conditions
- Running Endurance
- Being tested
- Respiratory muscle training, Sham training
- Keywords
- respiratory muscle, breathing pattern, exercise performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle trainingBehavioural
Daily training with a handheld device (Pressure threshold loading). 1x50 breaths with adjustments (gradually increasing levels).
Sham trainingBehavioural
Sham training with same handheld device. 50 breaths daily on the lowest level
| Study group | Role | What they receive |
|---|---|---|
| Training | Active comparator | respiratory muscle training (pressure threshold loading) Receives: Behavioral: Respiratory muscle training |
| sham training | Sham comparator | training with low resistance Receives: Behavioral: Sham training |
What is being measured
The primary outcome is the main question the study is designed to answer.
performance in the 500m run time trial
Measured: 6-8 weeks
Secondary outcomes (1)
maximum inspiratory pressure
Measured: 6-8- weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Running EnduranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Investigators
- Ulf Such, MD, Principal investigator, Institute for Sports Medicine and Prevention / Saarland Universitiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968448
- Sponsor's protocol ID
- Sportmed-Saarland-8/2009
- Status last verified
- Aug 2009
- First submitted
- 28 Aug 2009
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training (IMT) in Athletes
- ClinicalTrials.gov ID
- NCT00968448
- Acronym / sponsor ID
- Sportmed-Saarland-8/2009
- Conditions
- Running Endurance
- Keywords
- respiratory muscle, breathing pattern, exercise performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Active comparator | Behavioral: Respiratory muscle trainingrespiratory muscle training (pressure threshold loading) |
| sham training | Sham comparator | Behavioral: Sham trainingtraining with low resistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- well trained runners
Key exclusion criteria (3 listed)
- previous respiratory muscle training
- cardiovascular diseases
- impaired lung function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory muscle trainingDaily training with a handheld device (Pressure threshold loading). 1x50 breaths with adjustments (gradually increasing levels). | Behavioural | Training |
| Sham trainingSham training with same handheld device. 50 breaths daily on the lowest level | Behavioural | sham training |
Primary outcome
performance in the 500m run time trial
Time frame: 6-8 weeks
1 secondary outcome
maximum inspiratory pressure
Time frame: 6-8- weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Such, MD principal investigator
Institute for Sports Medicine and Prevention / Saarland Universitiy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle training in people with Running Endurance, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance in the 500m run time trial (time frame: 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2011.