NCT07311837

Brief Summary

Introduction: Body mass index (BMI) is a key parameter used for obesity classification and the evaluation and monitoring of individuals' health status. Obesity, described by the World Health Organization as a major global epidemic, remains one of the most significant preventable and manageable conditions contributing to increased risks of cardiovascular and metabolic diseases. In addition to BMI, anthropometric measurements such as the waist-to-hip ratio are crucial indicators for risk assessment. While numerous studies in the literature have addressed the detrimental effects of obesity on respiratory functions, no study has specifically examined the relationship between cough strength-a vital respiratory parameter that reflects expiratory muscle strength- and body composition, waist-to-hip ratio, and peripheral muscle strength. Furthermore, although several studies have investigated the association between grip strength-a recognized indicator of peripheral muscle function in healthy individuals-and cough strength, no research to date has explored the relationship between pinch grip strength and cough strength. Objective: This study aims to investigate the relationships among body composition, waist-to-hip ratio, peripheral muscle strength, and cough strength in healthy young adults. Methods: This study was designed as a cross-sectional analysis. After providing detailed information about the study to potential participants, written informed consent will be obtained in duplicate from those who agree to participate. Following the completion of a general assessment form that captures demographic characteristics, each participant's height will be measured using a measuring tape. Body composition parameters-including body weight, BMI, body fat percentage, total body water percentage, muscle mass, basal metabolic rate, and metabolic age-will be assessed using a bioelectrical impedance analysis device (Tanita) available at our faculty. Waist and hip circumferences will be measured and used to calculate the waist-to-hip ratio for each participant. Peripheral muscle strength will be assessed using a hydraulic hand dynamometer and a pinch meter, while cough strength will be evaluated using a peak cough expiratory flow meter (PEF meter). All measurements will be repeated three times, with the best result recorded for analysis. Results: Statistical analysis will be performed using IBM SPSS Statistics version 30 (SPSS Inc., Chicago, IL, USA). Normality of continuous variables will be assessed through normality tests, coefficient of variation, and graphical representations (e.g., histograms, detrended plots). Descriptive statistics will be presented as mean ± standard deviation for normally distributed variables, and as median and interquartile range for non-normally distributed variables. Categorical variables will be expressed as percentages (%). Pearson correlation analysis will be used for normally distributed variables, and Spearman correlation analysis for non-normally distributed ones. The appropriate correlation coefficients and p-values will be reported. A p-value of \<0.05 will be considered statistically significant. Discussion: Interpretation will be based on the results of the statistical analyses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

November 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

14 days

First QC Date

November 18, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

Body compositionWaist-to-hip ratioPeripheral muscle strengthPeak expiratory flowCough strength

Outcome Measures

Primary Outcomes (8)

  • Body weight

    It expresses body weight in kilograms.

    Baseline

  • Body mass index

    Body weight (kg) divided by the square of height (m2)

    Baseline

  • Body fat ratio

    A measure of body fat in percent (%).

    Baseline

  • Body fluid ratio

    A measure of the amount of fluid in the body expressed as a percentage (%).

    Baseline

  • Muscle ratio

    The measure that expresses the lean body weight, that is, the muscle ratio in the body.

    Baseline

  • Basal metabolic rate

    It is defined as the amount of calories the body burns while performing its basic, basal life-sustaining function (kcal and kj)

    Baseline

  • Metabolic age

    Metabolic age is a measure of how efficiently your body's metabolism works compared to other individuals in your age group (years).

    Baseline

  • Cough strength

    Cough strength is the measure that expresses peak-expiratory flow (PEF) during cough. It is measured with a PEF-meter.

    Baseline

Secondary Outcomes (3)

  • Waist-hip ratio

    Baseline

  • Handgrip strength

    Baseline

  • Pinch strength

    Baseline

Study Arms (1)

Healthy Young Adults

Healthy individuals between the ages of 18 and 30 who volunteer to participate in the study will be included in the study.

Eligibility Criteria

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

Healthy young individuals

You may qualify if:

  • Individuals between the ages of 18-30 who volunteered to participate in the study

You may not qualify if:

  • Individuals who have a serious orthopedic, neurological or systemic disease that would prevent participation in the study and who do not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigde Omer Halisdemir University, Faculty of Bor Health Sciences

Niğde, 51200, Turkey (Türkiye)

Location

Related Publications (1)

  • Mafort TT, Rufino R, Costa CH, Lopes AJ. Obesity: systemic and pulmonary complications, biochemical abnormalities, and impairment of lung function. Multidiscip Respir Med. 2016 Jul 12;11:28. doi: 10.1186/s40248-016-0066-z. eCollection 2016.

    PMID: 27408717BACKGROUND

Study Officials

  • Nazire Nur YILDIZ, Ph.D.

    Nigde Omer Halisdemir University

    STUDY CHAIR

Central Study Contacts

Nazire Nur YILDIZ, Ph.D.

CONTACT

Nurcan AYTEKİN, Student

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
P.T., Ph.D.

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 31, 2025

Study Start

February 15, 2026

Primary Completion

March 1, 2026

Study Completion

March 15, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Since the work has not started yet, it cannot be shared.

Locations