- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07311837
Investigating the Relationships Between Body Composition, Peripheral Muscle Strength, and Cough Force in Healthy Young Adults
Investigating the Relationships Between Body Composition, Waist/Hip Ratio, Peripheral Muscle Strength, and Cough Force in Healthy Young Adults
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nazire Nur YILDIZ, Ph.D.
- Phone Number: +905444184376
- Email: nazirenuryildiz@ohu.edu.tr
Study Contact Backup
- Name: Nurcan AYTEKİN, Student
- Phone Number: +905386941695
- Email: nnur_yildiz_58@hotmail.com
Study Locations
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Niğde, Turkey (Türkiye), 51200
- Nigde Omer Halisdemir University, Faculty of Bor Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individuals between the ages of 18-30 who volunteered to participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Body weight
Time Frame: Baseline
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It expresses body weight in kilograms.
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Baseline
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Body mass index
Time Frame: Baseline
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Body weight (kg) divided by the square of height (m2)
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Baseline
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Body fat ratio
Time Frame: Baseline
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A measure of body fat in percent (%).
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Baseline
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Body fluid ratio
Time Frame: Baseline
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A measure of the amount of fluid in the body expressed as a percentage (%).
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Baseline
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Muscle ratio
Time Frame: Baseline
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The measure that expresses the lean body weight, that is, the muscle ratio in the body.
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Baseline
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Basal metabolic rate
Time Frame: Baseline
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It is defined as the amount of calories the body burns while performing its basic, basal life-sustaining function (kcal and kj)
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Baseline
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Metabolic age
Time Frame: Baseline
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Metabolic age is a measure of how efficiently your body's metabolism works compared to other individuals in your age group (years).
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Baseline
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Cough strength
Time Frame: Baseline
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Cough strength is the measure that expresses peak-expiratory flow (PEF) during cough.
It is measured with a PEF-meter.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Waist-hip ratio
Time Frame: Baseline
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It is the result measure expressing the ratio of waist circumference measurement (cm) to hip circumference measurement (cm).
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Baseline
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Handgrip strength
Time Frame: Baseline
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Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength.
It is defined as an index of upper limb strength and functional recovery, measured using tools like the dynamometer, which is considered the gold standard for its reliability and validity.
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Baseline
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Pinch strength
Time Frame: Baseline
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Pinch strength refers to the force exerted during precision grasp activities, specifically when the thumb tip contacts the tip of one or more fingers, such as in two-point pinch or three-point pinch configurations.
It is a critical component of hand function that involves the coordinated action of the thumb and fingers.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nazire Nur YILDIZ, Ph.D., Nigde Omer Halisdemir University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025/09-10-TUBITAK 2209-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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