NCT06507969

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 9, 2024

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

22 days

First QC Date

July 7, 2024

Last Update Submit

November 29, 2024

Conditions

Keywords

body compositionRespiratory Function TestsSleep Quality

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    10 minute

Secondary Outcomes (2)

  • Functional Capacity

    6 minute

  • Pittsburg Sleep Quality Indeks

    5 minute

Study Arms (1)

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.

Other: The Effect of Body Composition on Respiratory Parameters, Functional Capacity and Sleep in Healthy Young Adults

Interventions

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

Healthy young adults aged 18-30 years

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Volunteer young adults between the ages of 18-30 who are willing to participate in the study

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Kent University

Istanbul, Kagıthane-Istanbul, 34413, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Body WeightSleep Initiation and Maintenance Disorders

Interventions

Sleep

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Melis USUL, RA.

    Istanbul Kent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 7, 2024

First Posted

July 18, 2024

Study Start

September 9, 2024

Primary Completion

October 1, 2024

Study Completion

November 15, 2024

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations