HealthyNCT06507969
The Effect of Body Composition on Respiratory Parameters, Functional Capacity and Sleep in Healthy Young Adults
An observational study of Healthy and Body Weight, run by Istanbul Kent University at 1 site in Turkey (Türkiye).
Trial summary
Body composition has a significant effect on the respiratory system. Both respiratory prediction of function and a prognostic tool evaluated in the cardiopulmonary system factor. Respiratory function, which directly affects respiratory muscle strength and respiratory muscle endurance covers a range of data. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Body Weight
- What is being tested?
- The Effect of Body Composition on Respiratory Parameters, Functional Capacity and Sleep in Healthy Young Adults
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2024to 15 Nov 2024
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Volunteer young adults between the ages of 18-30 who are willing to participate in the study
Who may be able to join
- Volunteer young adults between the ages of 18-30 who are willing to participate in the study
- Providing independent ambulation
- Individuals without cognitive/mental problems
Who cannot join
- Lack of co-operation
- Presence of diseases affecting the cardiac and pulmonary system
- Those with a history of neurological, rheumatic or metabolic diseases
- Pregnant women
- Presence of major musculoskeletal problems
- Individuals who smoke
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Kent University
Istanbul, Kagıthane-Istanbul, 34413
About this study
Body composition has a significant effect on the respiratory system. Both respiratory prediction of function and a prognostic tool evaluated in the cardiopulmonary system factor. Respiratory function, which directly affects respiratory muscle strength and respiratory muscle endurance covers a range of data. In the literature, the relationship between body composition and respiratory function. Although there are studies examining body composition in healthy young adults, the relationship between them has not been clearly demonstrated.
The aim of the study was to investigate the effects of body composition on respiratory function, respiratory muscle endurance, functional capacity and sleep quality.
Read more
For this purpose, at least 46 healthy young participants who fulfil the inclusion criteria will participate in the evaluation. Body composition parameters will be measured by the researchers using Tanita DC360 Body Analysis Scale. In pulmonary function test, forced vital capacity (FVC), forced expiratory volume in 1st second (FEV1), Tiffeneau ratio (FEV1/FVC), peak expiratory flow rate (PEF) values will be evaluated by the researchers with COSMED Pony FX (COSMED; Italy) spirometer and respiratory muscle endurance with Maximum Voluntary Ventilation test. Participants will answer the Pittsburg Sleep Quality Index. The 6-minute walk test will be applied to the participants with the instructions of the researchers.
Data will be analysed by SPSS Statistical Package for Social Sciences (SPSS) Version 20.0 (SPSS Inc., Chicago, Illinois) programme will be made using.
Read the detailed description
Body composition is an important determinant of health and can be used in the assessment of cardiopulmonary problems. Body mass index (BMI) in cardiopulmonary function is an independent prognostic factor. Fat and lean mass have also been identified as strong predictors of physical fitness and mortality.
Pulmonary function is a long-term determinant of all-cause mortality, particularly cardiovascular mortality. Pulmonary function may be affected by malnutrition, recurrent.
It may be influenced by various genetic or environmental factors such as infections and exposure to toxic substances, obesity and systemic diseases.Pulmonary function testing is one of the basic and essential tests for the diagnosis and evaluation of lung diseases such as lung dysfunction, chronic obstructive pulmonary disease (COPD) and asthma. Factors affecting pulmonary function include age, body weight and height, and gender. Since these factors are significantly related to pulmonary function, they are used to calculate the regression equation and predicted normal values of the pulmonary function test.
The correlation between body mass index (BMI), waist size, fat mass and pulmonary function has been studied since the late 1950s. However, the correlation between pulmonary function and body The study results of the correlation between body composition and respiratory function were found to be different from each other. In addition, the mechanism by which body composition affects respiratory function is not fully understood.
Obesity and thus abdominal adiposity also affect aerobic capacity, respiratory function and respiratory muscle strength. Fat accumulation on the chest and abdominal walls inhibits the movement of the respiratory muscles, increases pleural pressure and reduces lung compliance, resulting in a decrease in the compliance of the respiratory system as a whole. Due to all these causes, decreases in functional residual capacity, expiratory reserve volume, forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and respiratory muscle strength are observed.
Strength and endurance tests are recommended to determine decreases in respiratory muscle performance.
Although the number of studies examining the relationship between respiratory muscle strength and body composition is higher in the literature, it has been shown that endurance assessment is more functionally meaningful because inspiratory muscles are used at submaximal level in daily life activities.
Sleep quality is associated with many factors such as age, gender, genetic and environmental factors, social life, economic status, stress, pain, substance abuse, physical diseases, physical activity level, eating habits and obesity.
In the literature, there are many studies examining the relationship between obesity and sleep quality using body composition parameters such as Body Mass Index (BMI), waist circumference, waist-to-hip ratio, and body fat percentage. In some of these studies, it has been suggested that there is no relationship between obesity and sleep quality; in others, it has been shown that obesity is associated with sleep problems, this relationship can be explained by a bidirectional mechanism, sleep problems such as poor sleep quality lead to obesity due to abnormal changes in metabolic and endocrine functions, and obesity leads to various pathological conditions associated with respiration. Obstructive sleep apnoea and obesity hypoventilation syndrome are among these conditions. Therefore, body composition has a significant effect on sleep quality and thus respiratory parameters.
In the literature, there are studies examining the relationship between body composition and respiratory function and respiratory muscle strength in healthy young adults. However, there is no study in the literature investigating the relationship between body composition and respiratory muscle endurance, functional capacity, respiratory function and sleep quality. The aim of study was to investigate the effect of body composition on respiratory function, respiratory muscle strength, respiratory muscle endurance and functional capacity in healthy young adults.
- Conditions
- Healthy, Body Weight
- Being tested
- The Effect of Body Composition on Respiratory Parameters, Functional Capacity and Sleep in Healthy Young Adults
- Keywords
- body composition, Respiratory Function Tests, Sleep Quality
- Medical subject headings
- Body Weight, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Body Composition on Respiratory Parameters, Functional Capacity and Sleep in Healthy Young AdultsOther
Sociodemographic information of all participants will be obtained within the scope of the evaluations. Body composition parameters will be measured with Tanita DC360 Body Analysis Scale. In pulmonary function test, Forced vital capacity (FVC), Forced expiratory volume in 1st second (FEV1), Tiffeneau ratio (FEV1/FVC), peak expiratory flow rate (PEF) values will be evaluated with COSMED Pony FX (COSMED; Italy) spirometer. Respiratory muscle endurance will be assessed by Maximum Minute Ventilation will be determined. Pittsburg Sleep Quality, a reliable questionnaire that assesses sleep quality The index will be filled in by the participants. 6 Minutes to assess functional capacity A walking test will be performed and the distance travelled by individuals will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Healthy young adults aged 18-30 years | Sociodemographic information of all participants will be obtained within the scope of the evaluations. Body composition parameters will be measured with Tanita DC360 Body Analysis Scale. In pulmonary function test, Forced vital capacity (FVC), Forced expiratory volume in 1st second (FEV1), Tiffeneau ratio (FEV1/FVC), peak expiratory flow rate (PEF) values will be evaluated with COSMED Pony FX (COSMED; Italy) spirometer. Respiratory muscle endurance will be assessed by Maximum Minute Ventilation will be determined. Pittsburg Sleep Quality, a reliable questionnaire that assesses sleep quality The index will be filled in by the participants. 6 Minutes to assess functional capacity A walking test will be performed and the distance travelled by individuals will be recorded. Receives: Other: The Effect of Body Composition on Respiratory Parameters, Functional Capacity and Sleep in Healthy Young Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
The body analyses of the participants were performed by the bioelectrical impedance analysis technique by the researchers using "Tanita DC 360 Body Analyser Scale". Body mass index (kg/m2), muscle mass (kg), bone mass (kg) will be recorded by the researchers.
Measured: 10 minute
Respiratory parameters
Pulmonary function test is a test used to evaluate respiratory parameters.Pulmonary function test was planned by COSMED Pony FX in accordance with the American Thoracic Society and European Respiratory Society criteria. Forced vital capacity, forced expiratory volume in 1st second , Tiffeneau ratio (FEV1/FVC), peak expiratory flow rate values and percentage of predictive values will be recorded by the investigators.
Maximum Voluntary Ventilation test will be applied by the researchers to determine the respiratory muscle endurance of the participants.
Measured: 10 minute
Secondary outcomes (2)
Functional Capacity
The 6-minute walk test is a test that determines functional capacity. Participants will walk along a 30 metre straight corridor for 6 minutes.The distance covered by walking as fast as possible without running will be recorded by the investigators in metres.
Measured: 6 minute
Pittsburg Sleep Quality Indeks
Pittsburg Sleep Quality Index developed is a questionnaire that evaluates sleep quality. It will be used to evaluate the sleep quality of the participants. The scale consists of 24 questions in total. Sleep duration, subjective sleep quality, time to fall asleep, effectiveness of habitual sleep, presence of sleep disorders, use of medication to fall asleep and daytime sleep dysfunction.
Each item of the scale is evaluated between 0-3 points; the sum of the scores of the seven subcomponents gives the total score of the scale. The lowest score that can be obtained from the scale is 0 and the highest score is 21. A total score greater than 5 indicates that the sleep quality of the individual is not good.
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 posted18 Jul 2024
- Study start9 Sep 2024
- Primary completion1 Oct 2024
- Study completion15 Nov 2024
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.
- 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
- Other
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Kent University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Melis Usul, Istanbul Kent University
- Investigators
- Melis USUL, RA., Principal investigator, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507969
- Sponsor's protocol ID
- IstanbulKentU-FTR-MU-02
- Status last verified
- Nov 2024
- First submitted
- 7 Jul 2024
- Last updated
- 2 Dec 2024
- 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 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Composition on Respiratory Parameters, Functional Capacity and Sleep in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT06507969
- Acronym / sponsor ID
- IstanbulKentU-FTR-MU-02
- Conditions
- Healthy, Body Weight
- Keywords
- body composition, Respiratory Function Tests, Sleep Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Istanbul Kent UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 18 Jul 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.
Body composition has a significant effect on the respiratory system. Both respiratory prediction of function and a prognostic tool evaluated in the cardiopulmonary system factor. Respiratory function, which directly affects respiratory muscle strength and respiratory muscle endurance covers a range of data. In the literature, the relationship between body composition and respiratory function. Although there are studies examining body composition in healthy young adults, the relationship between them has not been clearly demonstrated.
The aim of the study was to investigate the effects of body composition on respiratory function, respiratory muscle endurance, functional capacity and sleep quality.
For this purpose, at least 46 healthy young participants who fulfil the inclusion criteria will participate in the evaluation. Body composition parameters will be measured by the researchers using Tanita DC360 Body Analysis Scale. In pulmonary function test, forced vital capacity (FVC), forced expiratory volume in 1st second (FEV1), Tiffeneau ratio (FEV1/FVC), peak expiratory flow rate (PEF) values will be evaluated by the researchers with COSMED Pony FX (COSMED; Italy) spirometer and respiratory muscle endurance with Maximum Voluntary Ventilation test. Participants will answer the Pittsburg Sleep Quality Index. The 6-minute walk test will be applied to the participants with the instructions of the researchers.
Data will be analysed by SPSS Statistical Package for Social Sciences (SPSS) Version 20.0 (SPSS Inc., Chicago, Illinois) programme will be made using.
Detailed description
Body composition is an important determinant of health and can be used in the assessment of cardiopulmonary problems. Body mass index (BMI) in cardiopulmonary function is an independent prognostic factor. Fat and lean mass have also been identified as strong predictors of physical fitness and mortality.
Pulmonary function is a long-term determinant of all-cause mortality, particularly cardiovascular mortality. Pulmonary function may be affected by malnutrition, recurrent.
It may be influenced by various genetic or environmental factors such as infections and exposure to toxic substances, obesity and systemic diseases.Pulmonary function testing is one of the basic and essential tests for the diagnosis and evaluation of lung diseases such as lung dysfunction, chronic obstructive pulmonary disease (COPD) and asthma. Factors affecting pulmonary function include age, body weight and height, and gender. Since these factors are significantly related to pulmonary function, they are used to calculate the regression equation and predicted normal values of the pulmonary function test.
The correlation between body mass index (BMI), waist size, fat mass and pulmonary function has been studied since the late 1950s. However, the correlation between pulmonary function and body The study results of the correlation between body composition and respiratory function were found to be different from each other. In addition, the mechanism by which body composition affects respiratory function is not fully understood.
Obesity and thus abdominal adiposity also affect aerobic capacity, respiratory function and respiratory muscle strength. Fat accumulation on the chest and abdominal walls inhibits the movement of the respiratory muscles, increases pleural pressure and reduces lung compliance, resulting in a decrease in the compliance of the respiratory system as a whole. Due to all these causes, decreases in functional residual capacity, expiratory reserve volume, forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and respiratory muscle strength are observed.
Strength and endurance tests are recommended to determine decreases in respiratory muscle performance.
Although the number of studies examining the relationship between respiratory muscle strength and body composition is higher in the literature, it has been shown that endurance assessment is more functionally meaningful because inspiratory muscles are used at submaximal level in daily life activities.
Sleep quality is associated with many factors such as age, gender, genetic and environmental factors, social life, economic status, stress, pain, substance abuse, physical diseases, physical activity level, eating habits and obesity.
In the literature, there are many studies examining the relationship between obesity and sleep quality using body composition parameters such as Body Mass Index (BMI), waist circumference, waist-to-hip ratio, and body fat percentage. In some of these studies, it has been suggested that there is no relationship between obesity and sleep quality; in others, it has been shown that obesity is associated with sleep problems, this relationship can be explained by a bidirectional mechanism, sleep problems such as poor sleep quality lead to obesity due to abnormal changes in metabolic and endocrine functions, and obesity leads to various pathological conditions associated with respiration. Obstructive sleep apnoea and obesity hypoventilation syndrome are among these conditions. Therefore, body composition has a significant effect on sleep quality and thus respiratory parameters.
In the literature, there are studies examining the relationship between body composition and respiratory function and respiratory muscle strength in healthy young adults. However, there is no study in the literature investigating the relationship between body composition and respiratory muscle endurance, functional capacity, respiratory function and sleep quality. The aim of study was to investigate the effect of body composition on respiratory function, respiratory muscle strength, respiratory muscle endurance and functional capacity in healthy young adults.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy young adults aged 18-30 years | – | Other: The Effect of Body Composition on Respiratory Parameters, Functional Capacity and Sleep in Healthy Young AdultsSociodemographic information of all participants will be obtained within the scope of the evaluations. Body composition parameters will be measured with Tanita DC360 Body Analysis Scale. In pulmonary function test, Forced vital capacity (FVC), Forced expiratory volume in 1st second (FEV1), Tiffeneau ratio (FEV1/FVC), peak expiratory flow rate (PEF) values will be evaluated with COSMED Pony FX (COSMED; Italy) spirometer. Respiratory muscle endurance will be assessed by Maximum Minute Ventilation will be determined. Pittsburg Sleep Quality, a reliable questionnaire that assesses sleep quality The index will be filled in by the participants. 6 Minutes to assess functional capacity A walking test will be performed and the distance travelled by individuals will be recorded. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteer young adults between the ages of 18-30 who are willing to participate in the study
Key inclusion criteria (3 listed)
- Volunteer young adults between the ages of 18-30 who are willing to participate in the study
- Providing independent ambulation
- Individuals without cognitive/mental problems
Key exclusion criteria (6 listed)
- Lack of co-operation
- Presence of diseases affecting the cardiac and pulmonary system
- Those with a history of neurological, rheumatic or metabolic diseases
- Pregnant women
- Presence of major musculoskeletal problems
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 |
|---|---|---|
| The Effect of Body Composition on Respiratory Parameters, Functional Capacity and Sleep in Healthy Young AdultsSociodemographic information of all participants will be obtained within the scope of the evaluations. Body composition parameters will be measured with Tanita DC360 Body Analysis Scale. In pulmonary function test, Forced vital capacity (FVC), Forced expiratory volume in 1st second (FEV1), Tiffeneau ratio (FEV1/FVC), peak expiratory flow rate (PEF) values will be evaluated with COSMED Pony FX (COSMED; Italy) spirometer. Respiratory muscle endurance will be assessed by Maximum Minute Ventilation will be determined. Pittsburg Sleep Quality, a reliable questionnaire that assesses sleep quality The index will be filled in by the participants. 6 Minutes to assess functional capacity A walking test will be performed and the distance travelled by individuals will be recorded | Other | Healthy young adults aged 18-30 years |
Primary outcome
Body composition
Time frame: 10 minute
The body analyses of the participants were performed by the bioelectrical impedance analysis technique by the researchers using "Tanita DC 360 Body Analyser Scale". Body mass index (kg/m2), muscle mass (kg), bone mass (kg) will be recorded by the researchers.
Respiratory parameters
Time frame: 10 minute
Pulmonary function test is a test used to evaluate respiratory parameters.Pulmonary function test was planned by COSMED Pony FX in accordance with the American Thoracic Society and European Respiratory Society criteria. Forced vital capacity, forced expiratory volume in 1st second , Tiffeneau ratio (FEV1/FVC), peak expiratory flow rate values and percentage of predictive values will be recorded by the investigators. Maximum Voluntary Ventilation test will be applied by the researchers to determine the respiratory muscle endurance of the participants.
2 secondary outcomes
Functional Capacity
Time frame: 6 minute
Pittsburg Sleep Quality Indeks
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 2 Dec 2024.
- 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.
Melis USUL, RA. principal investigator
Istanbul Kent 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 and Body Weight, run by Istanbul Kent 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 3 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 2 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?
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?
Body composition (time frame: 10 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 2 Dec 2024.