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临床试验/CTRI/2024/11/077273
CTRI/2024/11/077273尚未招募不适用

Comparison of functional capacity and dynapenia in diabetics and healthy adults- A comparative study.

未提供1 个研究点 分布在 1 个国家目标入组 68 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
68
试验地点
1
主要终点
1. SIX MINUTE WALK DISTANCE FROM SIX MINUTE

研究概览

简要总结

NEED OF STUDY

  1. Diabetes Mellitus is an increasing concern globally and in India

due to rapid changes seen in socioeconomic sector and lifestyle

changes.

  1. Various studies have shown that diabetes is associated with

abnormal lung function and reduced gaseous exchange. Also,

histopathological studies have shown an association between

diabetes mellitus and the thickening of alveolar epithelial basal

lamina.

  1. According to Hiroyasu Mori, 2019 et. al., dynapenia is more

frequent in individuals with diabetes mellitus.

  1. Comparing the effects of functional capacity and muscle strength

in diabetics and non-diabetics will help in understanding the

impact of diabetes on musculoskeletal as well as pulmonary

health which is important for daily living which will further aid in

risk assessment of individuals at higher risk.

  1. While going through literature searching, there is paucity of

literature which showed association of diabetes with dynapenia

and functional capacity. Therefore, this study aims to explore the

relationship between diabetic individuals and their muscle

strength along with their functional capacity and compare it with

the non-diabetic individuals for providing comprehensive

healthcare to the diabetic population.

  1. This study will also contribute to a more holistic approach to

diabetes management and will inform about the preventive

strategies and early interventions to improve the quality of life of

the individual.

AIM

To compare the functional capacity and dynapenia in individuals and

healthy adults.

OBJECTIVES

  1. To assess the functional capacity and muscle strength in diabetic individuals [Group A].

  2. To assess the functional capacity and muscle strength in healthy individuals [Group B].

  3. To compare the functional capacity and muscle strength in diabetic individuals [Group A] and healthy individuals [Group B].

PROCEDURE

Participants will be enrolled in the study depending on the selection criteria and willingness to participate in the study.

Case record form with demographic details and HbA1c levels which should be higher than 6.5% will be filled for the diabetics and OGTT levels (less than 140 mg/dL) will be filled for the healthy individuals.

Six-minute walk test will be assessed and hand grip strength using hand held

dynamometer will be assessed.

Data will be collected and statistically analysed.

DATA MANAGEMENT AND ANALYSIS PROCEDURE

All the data obtained from the participants will be kept confidential.

Both hard and soft copies will be maintained. The data will be stored

in excel sheets for analysis. Graph pad or SPSS software will be used

for analysis.

The data will be entered in Excel sheets.

The data will be measured in terms of six-minute walk test and

handgrip strength.

Differential analysis for two outcome measures will be done as

appropriate.

Data will be tested for normal distribution. An unpaired T test will be

used for analysis if the data passes normality tests, or else

Mann-Whittney U test will be used if the data fails to pass normality

test.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • GROUP A : INCLUSION CRITERIA:
  • Type 2 diabetic patients with duration minimum 1 year with HbA1c levels more than 6.5%
  • Age group between 40-60 years.
  • Both male and females.
  • GROUP B: INCLUSION CRITERIA:
  • Age, gender and BMI matched healthy individuals.
  • Oral Glucose Tolerance Test (OGTT) levels less than 140 mg/dL (7.8 mmol/L).

排除标准

  • EXCLUSION CRITERIA: [Group A and Group B]
  • Patients with any co-morbidities and those with major respiratory, musculoskeletal, or neurological diseases.
  • Patients with everyday smoking or any other addictions.
  • Those with any hand deformity or recent fracture.
  • Systolic blood pressure more than 180 mmhg
  • Resting diastolic blood pressure more than 100 mmhg
  • Resting Heart rate more than 120 bpm
  • Assistive aids for walking.
  • Major audio-visual impairment.
  • Patients unable to understand and follow the verbal commands.
  • Not willing to participate in the study.

结局指标

主要结局

1. SIX MINUTE WALK DISTANCE FROM SIX MINUTE

时间窗: 6 Months

WALK TEST [6MWT]

时间窗: 6 Months

2. HAND GRIP STRENGTH [HAND HELD DYNAMOMETER]

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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