Comparison of functional capacity and dynapenia in diabetics and healthy adults- A comparative study.
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
- Diabetes Mellitus is an increasing concern globally and in India
due to rapid changes seen in socioeconomic sector and lifestyle
changes.
- 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.
- According to Hiroyasu Mori, 2019 et. al., dynapenia is more
frequent in individuals with diabetes mellitus.
- 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.
- 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.
- 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
-
To assess the functional capacity and muscle strength in diabetic individuals [Group A].
-
To assess the functional capacity and muscle strength in healthy individuals [Group B].
-
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
Dr Hetal Mistry
Topiwala National Medical College and B.Y.L. Nair Charitable Hospital
