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CTRI Number  CTRI/2024/07/071094 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effects of lower limb muscle strength,functional mobility by giving isokinetic training in diabetic patients  
Scientific Title of Study   Effects of lower limb isokinetic training on muscle strength,functional mobility in type 2 diabetes mellitus:a randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ROSHTA KHAN 
Designation  PG STUDENT 
Affiliation  JAMIA HAMDARD UNIVERSITY,DELHI 
Address  Central library 5th floor department of Physiotherapy Jamia Hamdard University gate no 6

South
DELHI
110019
India 
Phone  9340620430  
Fax    
Email  roshtakhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Huma  
Designation  Assistant professor  
Affiliation  Jamia hamdard University,delhi 
Address  Central library 5th floor, department of physiotherapy,gate no:6, Jamia Hamdard

South
DELHI
110019
India 
Phone  9910598264  
Fax    
Email  humakhan@jamiahamdard.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Huma  
Designation  Assistant professor  
Affiliation  Jamia hamdard University,delhi 
Address  Central library 5th floor, department of physiotherapy,gate no:6, Jamia Hamdard

South
DELHI
110019
India 
Phone  9910598264  
Fax    
Email  humakhan@jamiahamdard.ac.in  
 
Source of Monetary or Material Support  
Rehabilitation centre near rabia masjid gate no 6 
 
Primary Sponsor  
Name  Roshta khan 
Address  Central library 5th floor department of Physiotherapy Jamia Hamdard University gate no 6 mehrauli badarpur 110019 India  
Type of Sponsor  Research institution and hospital 
 
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 
DrRoshta khan  Hakeem Abdul Hameed Centenary Hospital  Rehabilitation centre,room no:9,near Rabia masjid,gate no:6,jamia hamdard
South
DELHI 		 9340620430

roshtakhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Hamdard Institutional Ethical Committee   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 
Intervention  Isokinetic training   Giving isokinetic training to the diabetic patients of knee with concentric/concentric mode for 3 days/ week/8 week to evaluate the strength of knee and hba1c level in an individual  
Comparator Agent  Resisted exercise   Giving resisted exercise to the diabetic patients and healthy individual with the thera band for 3 days/week/8 weeks to evaluate the hba1c level and strength of knee muscles  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Subjects having controlled type 2 diabetes mellitus with classical symptoms of hyperglycemia (polyuria and polydipsia) since 5 years
Fasting plasma glucose (150-200mg/dl)
Hba1c level(7.0%-9.0%)
 
 
ExclusionCriteria 
Details  1 Nephropathy
2 Retinopathy
3 History of any Renal disease
4 History of any congenital problem
5 Severe or uncontrolled cardiac disease
6 Intermittent claudication of leg and ulcers of feet
7 Myopathy
8 Rheumatoid arthritis
9 History of Radiculopathy
10 Diabetic neuropathy
11 History of spinal injury
12 Bony disease or marked osteoporosis
13 Previous surgery of spine or shoulder.
14 Any cardiovascular disorder.
15 Visually or sensorymotor impaired subjects.
16 Uncooperative subjects
17 Hypertension
18 Metabolic abnormalities associated with diabetes
19 No previous guided excercise
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
6 minute walk test
Hba1c
Time up and go test
Isokinetic strength Dynamometer measurement 		 Pre and post 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/08/2024 
Date of Study Completion (India) 15/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/08/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 The aim of study is to find out the Effects of Lower Limb Isokinetic Training on muscle Strength and Functional mobility in Type 2 Diabetes Mellitus and to 

The purpose of this RCT is to evaluate the effect of lower limb isokinetic training on muscle strength and functional mobility in type 2 diabetes mellitus .The primary finding from this RCT is to find out that isokinetic training of lower limb during concentric contraction of knee extension and flexion alone was more effective than combination of resisted training and aerobic training at reducing HbA1c levels in normal-weight individuals with type 2 diabetes, and combination training had an intermediate effect.

Furthermore, isokinetic training of lower limb was an independent predictor of the reduction in HbA1c level.

 
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