Healthy AdultsNCT04272450
Respiratory Muscle Strength in Different Age Groups
An observational study of Healthy Adults, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
In determining respiratory muscle strength, mouth pressure measurement is most frequently used in the clinic. Determination of respiratory muscle strength loss provides benefits such as taking the decision to use individual rehabilitation methods, making the decision for extubation in patients with mechanical… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Healthy Adults
- What is being tested?
- respiratory muscle strenght measurement
- How many people
- 219 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2021to 1 Jan 2023
- Phase
- Observational
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- The age range is 20-70,
- Body mass index to be 18.0- 29.5 kg / m2
- No cardiac, neuromuscular or endocrine disease that may affect any respiratory muscle strength Respiratory function parameters to be normal,
- Not being a smoker
Who cannot join
- Not agreeing to participate in the study
- Not being able to adapt to the device
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Turkey
Istanbul, 34668
About this study
Official title: Respiratory Muscle Strength in Different Age Groups_Turkey
In determining respiratory muscle strength, mouth pressure measurement is most frequently used in the clinic. Determination of respiratory muscle strength loss provides benefits such as taking the decision to use individual rehabilitation methods, making the decision for extubation in patients with mechanical ventilation. But Turkey normative values, these values are not available. In the investigator's country, the respiratory muscle forces of the cases are evaluated by comparing them with the normal / expected values of the Scandinavian races that do not have similar anatomical features with the Turkish society, which causes errors in diagnosis.
The 250 healthy cases, whose age ranges are between 20-70, 20-29, 30-40, 40-49, 50-59 and 60-70, will be examined by a pulmonologist and asked if they have any disease that may affect respiratory muscle strength. Mouth pressure measurements will be made for healthy and inclusion criteria, and maximal inspiratory and expiratory pressure distributions will be examined.
- Conditions
- Healthy Adults
- Being tested
- respiratory muscle strenght measurement
- Keywords
- respiratory muscle, mouth pressure, normative data, predicted value, respiratory muscle strenght, Turkey, Istanbul
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory muscle strenght measurementDiagnostic test
Maximum inspiratory pressure-maximum expiratory pressure. The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strenght measurement
Respiratory mus cle strength will be measured by measuring mouth pressure. Maximal inspiratory (MIP) and expiratory pressures (MEP) will be recorded.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start21 Oct 2021
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272450
- Sponsor's protocol ID
- MIPMEP_Turkey
- Status last verified
- Nov 2022
- First submitted
- 12 Feb 2020
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Strength in Different Age Groups_Turkey
- ClinicalTrials.gov ID
- NCT04272450
- Acronym / sponsor ID
- MIPMEP_Turkey
- Conditions
- Healthy Adults
- Keywords
- respiratory muscle, mouth pressure, normative data, predicted value, respiratory muscle strenght, Turkey, Istanbul
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 17 Feb 2020 (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.
In determining respiratory muscle strength, mouth pressure measurement is most frequently used in the clinic. Determination of respiratory muscle strength loss provides benefits such as taking the decision to use individual rehabilitation methods, making the decision for extubation in patients with mechanical ventilation. But Turkey normative values, these values are not available. In the investigator's country, the respiratory muscle forces of the cases are evaluated by comparing them with the normal / expected values of the Scandinavian races that do not have similar anatomical features with the Turkish society, which causes errors in diagnosis.
The 250 healthy cases, whose age ranges are between 20-70, 20-29, 30-40, 40-49, 50-59 and 60-70, will be examined by a pulmonologist and asked if they have any disease that may affect respiratory muscle strength. Mouth pressure measurements will be made for healthy and inclusion criteria, and maximal inspiratory and expiratory pressure distributions will be examined.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (4 listed)
- The age range is 20-70,
- Body mass index to be 18.0- 29.5 kg / m2
- No cardiac, neuromuscular or endocrine disease that may affect any respiratory muscle strength Respiratory function parameters to be normal,
- Not being a smoker
Key exclusion criteria (2 listed)
- Not agreeing to participate in the study
- Not being able to adapt to the device
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 strenght measurementMaximum inspiratory pressure-maximum expiratory pressure. The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated. | Diagnostic test | – |
Primary outcome
Respiratory muscle strenght measurement
Time frame: 30 minutes
Respiratory mus cle strength will be measured by measuring mouth pressure. Maximal inspiratory (MIP) and expiratory pressures (MEP) will be recorded.
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 9 May 2023.
- Individual participant dataSharing planned: Undecided
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Healthy Volunteers
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?
An observational study of Healthy Adults, run by Istanbul Medipol University Hospital 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?
The sponsor lists 4 inclusion and 2 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 9 May 2023. 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?
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?
Respiratory muscle strenght measurement (time frame: 30 minutes). 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 9 May 2023.