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临床试验/CTRI/2024/08/073122
CTRI/2024/08/073122尚未招募不适用

Correlation of One Minute Sit to Stand Test with Six Minute Walk Test and Physical Activity in Individuals with Post-Tuberculosis Obstructive Airway Disease: A Cross-Sectional Study

未提供1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
1. 6 Minute Walk Distance (6MWD) in meters from 6 Minute Walk Test (6MWT)

研究概览

简要总结

NEED OF THE STUDY In individuals with COPD, Mjid Meriem et al, 2015 study have shown positive correlation between 1MSTS test and 6MWT but the cause is considered to be from the damage associated with cigarette smoking in developed countries. In developing countries tuberculous infection or bacterial infection are primary cause for developing obstructive airway disease. In India Brashier et al, 2007 reported an airflow obstruction prevalence of 46%, which rose in frequency over time following treatment completion. Another study by Pal et al, 2022 reported 51% individuals as having post TB COPD as a complication of TB with or without respiratory failure.

Due to pronounced inflammatory changes in pulmonary tuberculosis and structural changes within the muscle as compared to COPD due to non-infective cause, residual impairments persist post completion of disease treatment leading to increase in disease adjusted life years. This leads to increase in morbidity rate due to chronic respiratory diseases that occur as secondary complications post infection. This reduces the functional capacity of the individual which in turn reduces physical activity. With this the individual gets trapped within the vicious cycle of muscle weakness, reduction in functional capacity and physical activity.

1 Minute sit to stand test (1MSTS) is a reliable and valid alternative test to 6 Minute Walk Test (6MWT) in order to determine functional status of the individual with COPD. 1 Minute sit to stand test is also associated with peripheral muscle strength and endurance and a predictor of mortality. At times of space and time constraints, 1MSTS test can be used to assess the functional status of the individual and help determine physical activity level. Hence this study correlates 1MSTS test with 6MWT and Physical Activity in individuals with post tuberculosis obstructive airway disease.

AIM To correlate one minute sit to stand test with six minute walk test and physical activity in individuals with post- tuberculosis obstructive airway disease.

OBJECTIVES 1. To assess number of sit to stand repetitions (n) performed in one min sit to stand test (1MSTS test) in individuals with post tuberculosis obstructive airway disease.

  1. To assess six min walk test distance (6 MWD in meters) using six min walk test (6MWT) in individuals with post tuberculosis obstructive airway disease.

  2. To estimate physical activity level by calculating MET minutes/ week, sitting hours and category of physical activity using International physical activity questionnaire- short form (IPAQ - SF) in individuals with post tuberculosis obstructive airway disease.

  3. To correlate number of sit to stand repetitions with 6MWD, MET minutes/ week, sitting hours and category of Physical Activity in individuals with post tuberculosis obstructive airway disease.

PROCEDURE

Participants with post tb obstructive airway disease will be screened from Pulmonary medicine OPD and Physiotherapy OPD

Participants included according to inclusion criteria

Written informed consent will be filled

6 min walk test will be assessed

IPAQ - SF will be recorded during the rest period of 15 to 20 minutes

1 min sit to stand test will be assessed

Data will be analyzed

Data Management and analysis All 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. Data will be tested for normality. For correlation of number of sit to stand repetitions in 1 minute with 6-minute walk test distance if the data passes normality testing then Pearson’s correlation coefficient will be used for data analysis if it doesn’t pass normality testing then spearman’s correlation coefficient will be used for data analysis. Since IPAQ-SF is a questionnaire and a non-parametric variable, correlation of number of sit to stand repetitions in 1 minute with IPAQ-SF will be done using Spearman’s correlation coefficient.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Post -Tuberculosis Obstructive Airway Disease individuals referred by Chest Physicians 2.Willing to participate in the study.

排除标准

  • Active hemoptysis and Body temperature more than 100 DEGREE F
  • Uncontrolled hypertension with systolic BP more than 140 mm Hg and diastolic BP more than 90 mm Hg and resting heart rate more than 120 beats per min.
  • Resting oxygen saturation (SPO2 less than 90%)
  • Dyspnea of grade IV (Too breathless to leave the house or breathless while dressing or undressing on mMRC scale or breathless at rest)
  • Individuals with lower limb pain VAS more than 5 out of 10.

结局指标

主要结局

1. 6 Minute Walk Distance (6MWD) in meters from 6 Minute Walk Test (6MWT)

时间窗: 6 months

2. Number of Sit to Stand repetitions (n) from 1 Minute Sit to Stand test (1MSTS)

时间窗: 6 months

3. Metabolic Equivalent (MET minutes per week) from International physical activity questionnaire – Short form (IPAQ-SF)

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 Rachna Arora

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

研究点 (1)

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