Amateur AthletesNCT06611969
Inspiratory Muscle Training in Amateur Athletes
A study testing Exercise in people with Amateur Athletes, run by University of Valencia at 1 site in Spain.
Trial summary
The main objective of the study is to study the changes in FEV1 with the introduction of the specific inspiratory muscle training programme in the training programme of the popular athletes included. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amateur Athletes
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 26 Sep 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals willing to follow the 16-week running training plan
- Possibility of combining aerobic training with inspiratory muscle training
- Previous half marathon runner
Who cannot join
- - Exclusive or professional dedication to athletics
- Previous or current use of respiratory muscle training.
- Inadequate or health risk physical condition
- Significant chronic cardiorespiratory diagnoses (e.g. moderate-severe COPD).
- Neurological, muscular or neuromuscular problems that interfere with the ability to participate in tests and training protocols.
- Discontinuity in the performance of training.
- A terminal illness or any other major medical contraindication
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Inspiratory Muscle Training As a Complement to Usual Training on Respiratory Function and Performance in Amateur Athletes
The main objective of the study is to study the changes in FEV1 with the introduction of the specific inspiratory muscle training programme in the training programme of the popular athletes included. In addition, the secondary aims are to observe the differences in the respiratory capacities of the patients, in the vital signs, VO2 max, respiratory frequency and cardiac variability, as well as to assess the running performance of the participants.
Participants will be assigned to one of 2 study groups: IMT group (n=20) or not-IMT group (n=20) The IMT group will perform inspiratory muscle training in conjunction with the conventional marathon training plan. The not-IMT group will follow only the conventional marathon training plan. The study will be conducted over a 12 week period.
- Conditions
- Amateur Athletes
- Being tested
- Exercise
- Keywords
- inspiratory muscle training, respiratory function, performance, exercise
- Medical subject headings
- Respiratory Aspiration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
The training programme will consist of 5 weekly sessions of aerobic work, strength and mobility, plus specific training of the inspiratory muscles, 3 times a week, at a load between 50 and 80% of the maximum inspiratory pressure of each participant, after re-education of their diaphragmatic ventilation.
ExerciseProcedure or surgery
The training programme will consist of 5 weekly sessions of aerobic work, strength and mobility.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training (IMT) plus conventional training group | Experimental | IMT group will perform inspiratory muscle training in conjunction with the conventional marathon training plan Receives: Procedure: Exercise |
| Conventional training group (not-IMT) group | Active comparator | The not-IMT group will follow only the conventional marathon training plan Receives: Procedure: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory forced volume in first second
FEV1, in liters/second, assessed by spirometry
Measured: Before starting the intervention and after its completion (12 weeks)
Secondary outcomes (6)
Hearth rate variability
In miliseconds, assessed by hearth rate monitor
Measured: From the beginning to the end of the programme, recorded on a daily basis.
Hearth rate
Maximal and specifically in rest, measured in beats per minute, assessed by heart rate monitor
Measured: From the beginning to the end of the programme, recorded on a daily basis.
Respiratory rate
Measured in respirations per minute, estimated by the hearth rate monitor.
Measured: From the beginning to the end of the programme, recorded on a daily basis.
Running performance
Measured by running pace (time per kilometre) and perceived exertion (modified Borg scale 0-10), recorded individually in a written register.
Measured: From the beginning to the end of the programme, recorded on a daily basis.
Maximal inspiratory pressure
MIP, in cmH2O, assessed by inspiratory manouever
Measured: Before starting the intervention and after its completion (12 weeks)
Maximal consumption of oxygen
VO2 max, in ml/kg/min, estimated by heart rate monitor in training efforts.
Measured: Before starting the intervention and after its completion (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start26 Sep 2024
- Primary completion30 Jan 2025
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amateur AthletesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Martínez Arnau, University of Valencia
- Investigators
- Francisco Miguel Martínez Arnau, PhD, Study director, Universitat de Valencia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611969
- Sponsor's protocol ID
- 2024-FIS-3390079
- Status last verified
- Mar 2025
- First submitted
- 13 Sep 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training As a Complement to Usual Training on Respiratory Function and Performance in Amateur Athletes
- ClinicalTrials.gov ID
- NCT06611969
- Acronym / sponsor ID
- 2024-FIS-3390079
- Conditions
- Amateur Athletes
- Keywords
- inspiratory muscle training, respiratory function, performance, exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 25 Sep 2024 (actual)
- 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 main objective of the study is to study the changes in FEV1 with the introduction of the specific inspiratory muscle training programme in the training programme of the popular athletes included. In addition, the secondary aims are to observe the differences in the respiratory capacities of the patients, in the vital signs, VO2 max, respiratory frequency and cardiac variability, as well as to assess the running performance of the participants.
Participants will be assigned to one of 2 study groups: IMT group (n=20) or not-IMT group (n=20) The IMT group will perform inspiratory muscle training in conjunction with the conventional marathon training plan. The not-IMT group will follow only the conventional marathon training plan. The study will be conducted over a 12 week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training (IMT) plus conventional training group | Experimental | Procedure: ExerciseIMT group will perform inspiratory muscle training in conjunction with the conventional marathon training plan |
| Conventional training group (not-IMT) group | Active comparator | Procedure: ExerciseThe not-IMT group will follow only the conventional marathon training plan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals willing to follow the 16-week running training plan
- Possibility of combining aerobic training with inspiratory muscle training
- Previous half marathon runner
Key exclusion criteria (8 listed)
- - Exclusive or professional dedication to athletics
- Previous or current use of respiratory muscle training.
- Inadequate or health risk physical condition
- Significant chronic cardiorespiratory diagnoses (e.g. moderate-severe COPD).
- Neurological, muscular or neuromuscular problems that interfere with the ability to participate in tests and training protocols.
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 |
|---|---|---|
| ExerciseThe training programme will consist of 5 weekly sessions of aerobic work, strength and mobility, plus specific training of the inspiratory muscles, 3 times a week, at a load between 50 and 80% of the maximum inspiratory pressure of each participant, after re-education of their diaphragmatic ventilation. | Procedure or surgery | Inspiratory muscle training (IMT) plus conventional training group |
| ExerciseThe training programme will consist of 5 weekly sessions of aerobic work, strength and mobility. | Procedure or surgery | Conventional training group (not-IMT) group |
Primary outcome
Expiratory forced volume in first second
Time frame: Before starting the intervention and after its completion (12 weeks)
FEV1, in liters/second, assessed by spirometry
6 secondary outcomes
Hearth rate variability
Time frame: From the beginning to the end of the programme, recorded on a daily basis.
Hearth rate
Time frame: From the beginning to the end of the programme, recorded on a daily basis.
Respiratory rate
Time frame: From the beginning to the end of the programme, recorded on a daily basis.
Running performance
Time frame: From the beginning to the end of the programme, recorded on a daily basis.
Maximal inspiratory pressure
Time frame: Before starting the intervention and after its completion (12 weeks)
Maximal consumption of oxygen
Time frame: Before starting the intervention and after its completion (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Francisco Miguel Martínez Arnau, PhD study director
Universitat de Valencia, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Amateur Athletes, run by University of Valencia at 1 site in Spain.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. 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 Spain. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Expiratory forced volume in first second (time frame: Before starting the intervention and after its completion (12 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 26 Mar 2025.