HealthyNCT06573255
Assessment of Cardiopulmonary Fitness in Healthy Adults
An observational study of Healthy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This project was aimed to investigate cardiorespiratory fitness and the factors affecting cardiorespiratory fitness in healthy adults. The data obtained with this project will be normative values for the data obtained with CPET in healthy people. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Healthy group
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2023to Mar 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include healthy adult subjects without any known internal disease.
Who may be able to join
- 18-65 years of age,
- Volunteering to participate in the study,
- Co-operation,
- Being able to ambulate.
Who cannot join
- Having any known respiratory, cardiac, neurological or other internal disease or malignant disease,
- Having any problem or musculoskeletal system disorder that prevents walking,
- To have undergone any surgery within the last six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Ebru Calik Kutukcu, 3123051576 ext. 178, ecalik85@gmail.com
Ebru Calik Kutukcu, PhD
About this study
This project was aimed to investigate cardiorespiratory fitness and the factors affecting cardiorespiratory fitness in healthy adults. The data obtained with this project will be normative values for the data obtained with CPET in healthy people.
Read the detailed description
Cardiorespiratory fitness is one of the 'health-related physical fitness' components of physical fitness and can be expressed as 'the ability of the heart, lung and vascular system to deliver oxygen and nutrients to working muscles'. Cardiopulmonary exercise testing (CPET) is a common procedure used to assess cardiopulmonary fitness, identify physiological factors limiting exercise, identify potential therapeutic targets for these factors, and evaluate the effects of an intervention. Therefore, in this project, it was aimed to investigate cardiorespiratory fitness and the factors affecting cardiorespiratory fitness in healthy adults. The data obtained with this project will be normative values for the data obtained with CPET in healthy people.
- Conditions
- Healthy
- Being tested
- Healthy group
- Keywords
- cardiorespiratory fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy groupOther
Cardiopulmonary exercise test, respiratory function tests, respiratory muscle strength and physical activity assessment will be performed in this group.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness
In this parameter, which is assessed by cardiopulmonary exercise testing, the oxygen consumption measured during the test and the workload achieved in the test will be taken into consideration.
Measured: This test takes 15 to 20 minutes.
Secondary outcomes (3)
Respiratory Function Test
The pulmonary function test is a test that assesses respiratory function by performing certain manoeuvres.
Measured: This test takes 3 to 5 minutes.
Respiratory Muscle Strength Test
Inspiratory and expiratory muscle strengths will be measured separately by breathing manoeuvres.
Measured: This test takes 3 to 5 minutes.
Physical Activity
Physical activity level will be measured with International Physical Activity Questionnaire.
Measured: This questionnaire takes 1 minute.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start18 Apr 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Ebru Calik Kutukcu, PhD, Principal investigator, Hacettepe Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573255
- Sponsor's protocol ID
- GO 23/211
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiopulmonary Fitness in Healthy Adults
- ClinicalTrials.gov ID
- NCT06573255
- Acronym / sponsor ID
- GO 23/211
- Conditions
- Healthy
- Keywords
- cardiorespiratory fitness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 27 Aug 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 project was aimed to investigate cardiorespiratory fitness and the factors affecting cardiorespiratory fitness in healthy adults. The data obtained with this project will be normative values for the data obtained with CPET in healthy people.
Detailed description
Cardiorespiratory fitness is one of the 'health-related physical fitness' components of physical fitness and can be expressed as 'the ability of the heart, lung and vascular system to deliver oxygen and nutrients to working muscles'. Cardiopulmonary exercise testing (CPET) is a common procedure used to assess cardiopulmonary fitness, identify physiological factors limiting exercise, identify potential therapeutic targets for these factors, and evaluate the effects of an intervention. Therefore, in this project, it was aimed to investigate cardiorespiratory fitness and the factors affecting cardiorespiratory fitness in healthy adults. The data obtained with this project will be normative values for the data obtained with CPET in healthy people.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include healthy adult subjects without any known internal disease.
Key inclusion criteria (4 listed)
- 18-65 years of age,
- Volunteering to participate in the study,
- Co-operation,
- Being able to ambulate.
Key exclusion criteria (3 listed)
- Having any known respiratory, cardiac, neurological or other internal disease or malignant disease,
- Having any problem or musculoskeletal system disorder that prevents walking,
- To have undergone any surgery within the last six months
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 |
|---|---|---|
| Healthy groupCardiopulmonary exercise test, respiratory function tests, respiratory muscle strength and physical activity assessment will be performed in this group. | Other | – |
Primary outcome
Cardiorespiratory Fitness
Time frame: This test takes 15 to 20 minutes.
In this parameter, which is assessed by cardiopulmonary exercise testing, the oxygen consumption measured during the test and the workload achieved in the test will be taken into consideration.
3 secondary outcomes
Respiratory Function Test
Time frame: This test takes 3 to 5 minutes.
Respiratory Muscle Strength Test
Time frame: This test takes 3 to 5 minutes.
Physical Activity
Time frame: This questionnaire takes 1 minute.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ebru Calik Kutukcu, PhD principal investigator
Hacettepe Univesity
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, run by Hacettepe 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 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: status not confirmed, as of the sponsor's last update on 27 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebru Calik Kutukcu, PhD (3123051576, ecalik85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (time frame: This test takes 15 to 20 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 27 Aug 2024; AzTrials last refreshed its copy on 9 Nov 2026.