Healthy Individuals (Controls)NCT06742372
Effects of Combined Exercise Training Modality
A study testing combined inspiratory and aerobic exercise training and aerobic exercise training in people with Healthy Individuals (Controls), run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of combined Inspiratory Muscle Training and aerobic exercise on diaphragm and pulmonary functions, respiratory muscle function, performance, and body composition Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals (Controls)
- What is being tested?
- combined inspiratory and aerobic exercise training and aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2023to 31 Mar 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:aged between 18 and 40 years who have physical activity levels above 600 MET-min/week -
Exclusion Criteria:Individuals who were diagnosed with any cardiopulmonary or other chronic diseases, have any infections or limitations preventing them from doing an activity during assessment or intervention, do exercise regularly, and have smoked over 10 pack-years
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combined Exercise Training Modality on Diaphragm Function and Performance
This study aims to investigate the effects of combined Inspiratory Muscle Training and aerobic exercise on diaphragm and pulmonary functions, respiratory muscle function, performance, and body composition
- Conditions
- Healthy Individuals (Controls)
- Being tested
- combined inspiratory and aerobic exercise training, aerobic exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined inspiratory and aerobic exercise trainingOther
combined inspiratory and aerobic exercise training will be performed in healthy individuals
aerobic exercise trainingOther
aerobic exercise training will be performed in healthy individuals
| Study group | Role | What they receive |
|---|---|---|
| combined inspiratory and aerobic exercise training | Experimental | Not described Receives: Other: combined inspiratory and aerobic exercise training |
| aerobic exercise training | Experimental | Not described Receives: Other: aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device .
Measured: First day
diaphragm thickness
Measured: Second day
diaphragm stiffness
Measured: Second day
Secondary outcomes (7)
Inspiratory muscle endurance
Measured: First day
FEV1
Measured: First day
FVC
Measured: First day
FEV1/FVC
Measured: First day
PEF
Measured: First day
FEF2575
Measured: First day
Running Based Anaerobic Sprint Test (RAST test)
Measured: Second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start12 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Individuals (Controls)Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha ÇELİK, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742372
- Sponsor's protocol ID
- 310783
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Celik Z, Guzel NA, Allahverdiyeva S, Sendur HN, Cerit MN. Effects of simultaneous aerobic and inspiratory muscle training on diaphragm function, respiratory muscle strength, endurance, and fatigue index: randomized-controlled trial. Eur J Appl Physiol. 2025 Dec;125(12):3769-3783. doi: 10.1007/s00421-025-05868-1. Epub 2025 Jul 2.
PubMed 40601012
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Exercise Training Modality on Diaphragm Function and Performance
- ClinicalTrials.gov ID
- NCT06742372
- Acronym / sponsor ID
- 310783
- Conditions
- Healthy Individuals (Controls)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 19 Dec 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.
This study aims to investigate the effects of combined Inspiratory Muscle Training and aerobic exercise on diaphragm and pulmonary functions, respiratory muscle function, performance, and body composition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined inspiratory and aerobic exercise training | Experimental | Other: combined inspiratory and aerobic exercise training |
| aerobic exercise training | Experimental | Other: aerobic exercise training |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| combined inspiratory and aerobic exercise trainingcombined inspiratory and aerobic exercise training will be performed in healthy individuals | Other | combined inspiratory and aerobic exercise training |
| aerobic exercise trainingaerobic exercise training will be performed in healthy individuals | Other | aerobic exercise training |
Primary outcome
Respiratory muscle strength
Time frame: First day
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device .
diaphragm thickness
Time frame: Second day
diaphragm stiffness
Time frame: Second day
7 secondary outcomes
Inspiratory muscle endurance
Time frame: First day
FEV1
Time frame: First day
FVC
Time frame: First day
FEV1/FVC
Time frame: First day
PEF
Time frame: First day
FEF2575
Time frame: First day
Running Based Anaerobic Sprint Test (RAST test)
Time frame: Second day
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 19 Dec 2024.
- Derived from this study: PubMed 40601012Celik Z, Guzel NA, Allahverdiyeva S, Sendur HN, Cerit MN. Effects of simultaneous aerobic and inspiratory muscle training on diaphragm function, respiratory muscle strength, endurance, and fatigue index: randomized-controlled trial. Eur J Appl Physiol. 2025 Dec;125(12):3769-3783. doi: 10.1007/s00421-025-05868-1. Epub 2025 Jul 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined inspiratory and aerobic exercise training and aerobic exercise training in people with Healthy Individuals (Controls), run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Dec 2024. 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 Turkey (Türkiye). 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?
Respiratory muscle strength (time frame: First day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06742372, which also lists 1 linked publication.
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 19 Dec 2024.