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临床试验/CTRI/2025/07/091526
CTRI/2025/07/091526尚未招募不适用

Association between physical activity and Aerobic capacity in individuals with Unilateral transtibial amputation Secondary to diabetes mellitus in pre Prosthetic phase.

Aaditee Yadav1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2025年8月13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
29
试验地点
1
主要终点
1.VO2 max using the 6-minute walk test.

研究概览

简要总结

Diabetes has made its mark in the community, as its prevalence is four times higher than all cancers. With the increase in life expectancies, it has contributed significantly to the exponential rise, it now contributes to global mortality.Diabetes can lead to several severe pathophysiological changes such as ischemia, deformities, neuropathy, disturbed muscle balance and their functions, malposition, loss of mobility and sensitivity, nonhealing open wound, ulcer, or a combination of all especially at distal end of leg i.e the foot has the ability to the process of amputation.The goal of treatment for diabetic patients is to facilitate a tailormade treatment plan.To improve hyperglycemic levels, to improve health, to improve quality of life, to prevent further complications and premature mortality, engaging in physical activity & behaviors is a key component.If failed to comply by the above-mentioned measures for hyperglymic control,it may lead to amputation.A lower limb amputation leads to reduced mobility, and the performance of activities of daily living is hampered.This limitation of the function and structure of the body impacts the quality of life.reduced functional mobility leads to decreased cardiovascular endurance and a higher prevalence of depression, as individuals with lower limb amputation are often confined to their homes and may adopt either a low-active or sedentary lifestyle and may lead to more energy expenditure. This results in decreased cardiovascular fitness, weight gain, uncontrolled glycemic levels,vulnerability to another amputation, Reduced quality of life and an increased fear of falling. This may in turn further hinder gait training after the procurement of a prosthesis.Thus it would be of interest to assess physical activity and aerobic capacity in individuals with unilateral transtibial amputation in the preprosthetic phase and observe how each relates to the other.

Methodology-The Study design is Cross Sectional observational studywith Study setting in Teritary care setting and Rehabilitation center of duration 6 Months and Sampling methodwill be Convenience sampling with a sample size of 29.Those who will give informed consent will be screened for inclusion and exclusion criteria, and those who will fulfill the criteria will be included in the study as per voluntary enrolment. To assess physical activity, subjects will be assessed by the number of steps for which a Pedometer will be utilized. Average of three days will be noted.To assess aerobic capacity, 6-minute walk test will be used.

Statistical Analysis-The normality of data will be assessed using the Shapiro-Wilk test. A p value of less than < 0.05 will be considered statistically significant.If data passes normality test,Pearsons correlation coefficient test will be used.If data doesn’t pass the normality test,Spearmans correlation correlation test will be used.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Day(s) 至 60.00 Day(s)(—)
性别
All

入选标准

  • INDIVIDUALS WHO HAS UNDERGONE UNILATERAL TRANSTIBIAL AMPUTATION SECONDARY TO TYPE 2 DIABETES MELLITUS.
  • INDIVIDUALS IN PRE PROSTHETIC PHASE.
  • INDIVIDUALS OF FUNCTIONAL LEVEL K2-K4 OF MEDICARE FUNCTIONAL CLASSIFICATION SCREENED BY AMPUTEE MOBILITY PREDICTOR.

排除标准

  • 未提供

结局指标

主要结局

1.VO2 max using the 6-minute walk test.

时间窗: 1.Number of steps in a day using Pedometer.

次要结局

未报告次要终点

研究者

发起方
Aaditee Yadav
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Aaditee Yadav

ALL INDIA INSTITUTE OF PHYSICAL MEDICINE AND REHABILITATION,HAJI ALI

研究点 (1)

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