跳至主要内容
临床试验/CTRI/2024/07/070736
CTRI/2024/07/070736尚未招募不适用

Correlation of 6 minute walking performance with Quality of Life in Geriatric Population

Saptarshi Hazra1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
101
试验地点
1
主要终点
1. Six minute walking distance in meters

研究概览

简要总结

This study titled "Correlation of 6 minute walking performance with Quality of Life in Geriatric Population" is a single centred, cross-sectional, observational study to be held at Department of Physical Medicine and Rehabilitation, AIIMS Guwahati for a period of two years. 

The study aims to correlate the performance in 6 minute walk test with Quality of Life in geriatric population aged 60 years and above. The study will measure the performance in 6 minute walk test in terms of total distance covered in meters and assess the quality of life in terms of SF 36 scores, and thereby the two variables will be correlated to assess the applicability of 6 minute walk test as a predictor of Quality of Life in geriatric population.

After informed consent and initial health assessment, the participants would be asked to fill up the pre-validated, free to use SF-36 Questionnaire. After the test, the 6 minute walking distance would be recorded as per American Thoracic Society Guidelines, and performance would be correlated with the SF 36 responses to find association. The study does not involve any intervention or randomization.

Confidentiality of subjects would be maintained as per ICMR Guidelines. Both Participant Information Sheet and Informed Written consent will be in English, Hindi And Assamese language (language preferred by the participant). The estimated sample size of the study is 101. Statistical analysis will be done by suitable tests like frequency percentage, Student’s t-test, Chi Square test, Pearson Correlation coefficient and Spearman rank correlation with a p value of less than 0.05 to be considered statistically significant. The study involves less than minimal risk. There is no conflict of interest.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Age 60 years and above Individuals not involved in any competitive sports Subjects independent in basic activities of daily life.

排除标准

  • Individuals with significant visual or hearing impairment Uncontrolled hypertension or diabetes mellitus Symptomatic cardiopulmonary disease Severe renal or hepatic disease Uncontrolled epilepsy Progressive neurological disease Chronic debilitating arthritis, low back pain Present acute or terminal illness Use of walking aids Any neurological, skeletal muscle or joint disturbance significantly affecting activities of daily life (ADL) Inability to provide proper response to the Quality of life questionnaire Individuals with history of smoking, alcohol and drug abuse.

结局指标

主要结局

1. Six minute walking distance in meters

时间窗: Baseline

2. Quality of Life as per Short Form 36 Health Survey score

时间窗: Baseline

次要结局

  • Correlation of Six Minute Walking Performance with Quality of Life(Baseline)

研究者

发起方
Saptarshi Hazra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Saptarshi Hazra

All India Institute of Medical Sciences Guwahati

研究点 (1)

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