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CTRI Number  CTRI/2024/11/077273 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 22/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Comparison of abilities to perform activities of daily living and loss of muscle strenghth due to aging in diabetics and healthy adults 
Scientific Title of Study   Comparison of functional capacity and dynapenia in diabetics and healthy adults- A comparative study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hetal Mistry 
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD 24, Physiotherapy department, PT School and Centre,Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai,Maharashtra

Mumbai
MAHARASHTRA
400008
India 
Phone  9892971248  
Fax    
Email  hetalmistry1975@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hetal Mistry 
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD 24, Physiotherapy department, PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai,Maharashtra


MAHARASHTRA
400008
India 
Phone  9892971248  
Fax    
Email  hetalmistry1975@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Sanchita Sontakke 
Designation  Post Graduate Student 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD 24, Physiotherapy department, PT School and Centre, Topiwala National Medical College and Dr B.Y.L.Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai,Maharashtra

Mumbai
MAHARASHTRA
400008
India 
Phone  8390541085  
Fax    
Email  sanchitasontakke20@gmail.com  
 
Source of Monetary or Material Support  
P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hetal Mistry  P.T School & Centre, T.N.M.C & B.Y.L Ch Nair Hospital  OPD-24 (M building), Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 9892971248

hetalmistry1975@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  GROUP A :
INCLUSION CRITERIA:
1. Type 2 diabetic patients with duration minimum 1 year with
HbA1c levels more than 6.5%
2. Age group between 40-60 years.
3. Both male and females.
GROUP B:
INCLUSION CRITERIA:
1. Age, gender and BMI matched healthy individuals.
2. Oral Glucose Tolerance Test (OGTT) levels less than 140 mg/dL
(7.8 mmol/L)  
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA: [Group A and Group B]
1. Patients with any co-morbidities and those with major respiratory,
musculoskeletal, or neurological diseases.
2. Patients with everyday smoking or any other addictions.
3. Those with any hand deformity or recent fracture.
4. Systolic blood pressure more than 180 mmhg
5. Resting diastolic blood pressure more than 100 mmhg
6. Resting Heart rate more than 120 bpm
7. Assistive aids for walking.
8. Major audio-visual impairment.
9. Patients unable to understand and follow the verbal commands.
10. Not willing to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. SIX MINUTE WALK DISTANCE FROM SIX MINUTE
WALK TEST [6MWT]
2. HAND GRIP STRENGTH [HAND HELD DYNAMOMETER]

 		 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.
2. 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. 
3. According to Hiroyasu Mori, 2019 et. al., dynapenia is more
frequent in individuals with diabetes mellitus.
4. 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.
5. 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.
6. 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.

 
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