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临床试验/CTRI/2024/11/077447
CTRI/2024/11/077447尚未招募不适用

Correlation between functional capacity and respiratory muscle strength in adults with normal-weight obesity syndrome.

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1.Six-minute walk test(6MWT)

研究概览

简要总结

NEED OF STUDY

Normal weight obesity elevates the likelihood of developing non-communicable diseases, metabolic syndrome, and cardiovascular-related mortality.

According to Lana P. Franco, Carla C. Moris, it is crucial to characterize the normal-weight obesity syndrome and recognize the risks associated to health since, body composition assessment is usually not conducted in outpatient settings. Clarity about diagnosis, prevalence and the clinical effects of normal-weight obesity syndrome will aid healthcare providers in integrating targeted measures into healthcare plans. This includes periodically assessing adiposity, even among those with adequate BMI, to preserve health and minimize disease risks within normal-weight obese populations.

People who have normal-weight obesity are not noticeably different from those who have normal weight without excess fat when using regular check-up methods. This makes it hard to identify them and create health- improving plans. Therefore, it’s important to make a strong effort to understand their physical fitness as it can provide insights into the impact of excess body fat on the respiratory system despite appearing to have a normal weight.

Understanding how respiratory muscle strength relates to functional capacity could help in revealing potential health risks associated with normal weight-obesity and its effects on respiratory function, which might not be evident based solely on BMI measurements. It will also help in development of targeted interventions or exercise programs to improve both functional capacity and respiratory muscle strength in this specific population.

Conducting this study in the age group 18 to 35 is particularly relevant as it addresses a critical phase of adulthood when lifestyle habits and health patterns are often established. This study can provide insights into early indicators of health risks associated with normal weight obesity.

Examining this correlation can contribute to a deeper understanding of how normal weight obesity affects overall health, potentially identifying early markers of respiratory issues. Additionally, the results may also provide guidance for public health programmes aimed at promoting a holistic approach to well-being in this specific population.

Therefore, our aim is to study the correlation between functional capacity and respiratory muscle strength in adults with normal-weight obesity syndrome

AIM

The aim of the study is to find out the correlation between functional capacity and respiratory muscle strength in adults with normal-weight obesity syndrome.

OBJECTIVES

1.To assess functional capacity in adults with normal-weight obesity syndrome.

2.To assess respiratory muscle strength in adults with normal-weight obesity syndrome.

3.To find correlation between functional capacity and respiratory muscle strength in adults with normal-weight obesity syndrome.

PROCEDURE

Participants will be included in the study after screening for the inclusion and exclusion criteria.

Body fat percentage will be measured by skinfold thickness measurement according to ACSM guidelines.

A written consent will be obtained from the participants after explaining the study procedure in detail.

Basic demographic details, anthropometric measures, vital parameters, comorbidity details will be taken.

Respiratory muscle strength will be assessed by using respiratory pressure meter and three readings will be taken of maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP).

Vitals will be measured (HR, BP, RR, SPO2, RPE) and participant will then be made to perform the Six Minute Walk Test on the same day. The participants will be under observation throughout the test and vitals will be measured immediately after completion of test.

All data obtained from the participants will be kept confidential.

Data will be collected and analyzed.

DATA MANAGEMENT AND ANALYSIS

All the data obtained from the participants will be kept confidential. Both hard and soft copy will be maintained. The data will be stored in excel sheets for analysis. Graph pad or SPSS software will be used for analysis.

PLAN FOR STATISTICAL ANALYSIS

The data will be entered in excel sheets for analysis.

Functional capacity will be assessed by 6-minute walk test and descriptive analysis will be done.

Respiratory muscle strength will be assessed by measuring Maximum Inspiratory Pressure and Maximum Expiratory

Pressure (by using respiratory pressure meter) and descriptive analysis will be done.  Data will be tested for normality.

If the data passes the normality test, parametric–Pearson correlation test will be used.

If the data does not pass normality test, non-parametric- Spearman correlation test will be used

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 1 Both males and females 2 Age group of 18 to 35 years 3 BMI less than 24.9 kg per meter square 4 Males having body fat percentage greater than 25 percent and females having body fat percentage greater than 35 percent according to WHO.

排除标准

  • 1 Those with major respiratory, musculoskeletalor neurological diseases 2 Smokers or recent quitters 3 Assistive aids for walking 4 Professional athletes 5 Patients unable to understand and follow the verbal commands 6 Major audio-visual impairment 7 Systolic blood pressure more than 180 mmhg 8 Resting Diastolic blood pressure more than 100 mmhg 9 Resting HR more than 120 bpm 10 Not willing to participate in the study.

结局指标

主要结局

1.Six-minute walk test(6MWT)

时间窗: 6 months

2. Maximum Inspiratory Pressure and Maximum Expiratory Pressure

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Hetal Mistry

Topiwala National Medical College and B.Y.L. Nair Charitable Hospital

研究点 (1)

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