Healthy VolunteersNCT05237427
Inspiratory Muscle Endurance of Adults
An observational study of Healthy Volunteers, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the reference value ranges for healthy adults of the incremental threshold load test, which evaluates respiratory muscle endurance. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 18 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers between the ages of 18-35
Who may be able to join
- Being between the ages of 18-35
- Not having any disease
- Not exercising regularly
- Not smoking
Who cannot join
- Having a respiratory disease
- Have heart disease
- Have a neuromuscular disease
- Have Scoliosis
- Having had thoracic surgery
- Having experienced the respiratory muscle endurance protocol before
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
Official title: Determination of Respiratory Muscle Endurance in Healthy Adult Individuals
The aim of this study is to determine the reference value ranges for healthy adults of the incremental threshold load test, which evaluates respiratory muscle endurance.
Read the detailed description
Since respiratory muscles are used in daily life at the submaximal level, evaluation of their endurance is more meaningful functionally. In addition, evaluation of endurance with respiratory muscle strength is effective in determining respiratory muscle dysfunction. Failure to routinely evaluate respiratory muscle endurance, which is one of the main components of respiratory muscle function, may lead to failure to identify respiratory muscle dysfunction in early stage respiratory patients who have not yet developed muscle strength loss. However, normal value ranges have not been determined for the respiratory muscle endurance test.
Determining the normal value ranges for this test will help determine muscle fatigue and investigate the physiological course in respiratory diseases.
- Conditions
- Healthy Volunteers
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental threshold loading test.
A measure of endurance of inspiratory muscles.
Measured: 15 minute
Maximal inspiratory pressure
A measure of the strength of inspiratory muscles
Measured: 20 minute
Secondary outcomes (4)
Pulmonary function test - Forced expiratory volume in 1 second (FEV1)
The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. It is lung function test that are measured during spirometry. This pulmonary function test measurements were made to confirm that the respiratory function parameters of the participants were within the normal range. .
Measured: 5 minute
Pulmonary function test - Forced vital capacity (FVC)
Forced vital capacity (FVC) is lung function test that are measured during spirometry. This pulmonary function test measurement is applied to confirm that the respiratory function parameters of the participants were within the normal range.
Measured: 5 minute
Maximal voluntary ventilation (MVV)
It is a test that measures inspiratory endurance. MVV is the largest amount of air that a person can inhale and then exhale during a 12- to 15-s interval with maximal voluntary effort. It is determined by spirometry measurement.
Measured: 5 minute
International Physical Activity Questionnaire - Short Form
This questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in the metabolic equivalent of task (MET)-minute/week and time spent sitting.
Measured: 5 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Sep 2020
- Primary completion30 Sep 2022
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda GOKCEN, Kutahya Health Sciences University
- Investigators
- Selda Gokcen, Principal investigator, Kutahya Health Sciences UniversityOzgen Aras, Study director, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237427
- Sponsor's protocol ID
- 100
- Status last verified
- Mar 2023
- First submitted
- 18 Jan 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Respiratory Muscle Endurance in Healthy Adult Individuals
- ClinicalTrials.gov ID
- NCT05237427
- Acronym / sponsor ID
- 100
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 14 Feb 2022 (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 aim of this study is to determine the reference value ranges for healthy adults of the incremental threshold load test, which evaluates respiratory muscle endurance.
Detailed description
Since respiratory muscles are used in daily life at the submaximal level, evaluation of their endurance is more meaningful functionally. In addition, evaluation of endurance with respiratory muscle strength is effective in determining respiratory muscle dysfunction. Failure to routinely evaluate respiratory muscle endurance, which is one of the main components of respiratory muscle function, may lead to failure to identify respiratory muscle dysfunction in early stage respiratory patients who have not yet developed muscle strength loss. However, normal value ranges have not been determined for the respiratory muscle endurance test.
Determining the normal value ranges for this test will help determine muscle fatigue and investigate the physiological course in respiratory diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers between the ages of 18-35
Key inclusion criteria (4 listed)
- Being between the ages of 18-35
- Not having any disease
- Not exercising regularly
- Not smoking
Key exclusion criteria (6 listed)
- Having a respiratory disease
- Have heart disease
- Have a neuromuscular disease
- Have Scoliosis
- Having had thoracic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incremental threshold loading test.
Time frame: 15 minute
A measure of endurance of inspiratory muscles.
Maximal inspiratory pressure
Time frame: 20 minute
A measure of the strength of inspiratory muscles
4 secondary outcomes
Pulmonary function test - Forced expiratory volume in 1 second (FEV1)
Time frame: 5 minute
Pulmonary function test - Forced vital capacity (FVC)
Time frame: 5 minute
Maximal voluntary ventilation (MVV)
Time frame: 5 minute
International Physical Activity Questionnaire - Short Form
Time frame: 5 minute
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 3 Mar 2023.
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Screening Protocol
Pain
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.
Selda Gokcen principal investigator
Kutahya Health Sciences University
Ozgen Aras study director
Kutahya Health Sciences University
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 Volunteers, run by Kutahya Health Sciences 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?
The sponsor lists 4 inclusion and 6 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 3 Mar 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?
Incremental threshold loading test. (time frame: 15 minute). The study lists 2 primary outcomes in all. 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 3 Mar 2023.