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CTRI Number  CTRI/2017/09/009602 [Registered on: 01/09/2017] Trial Registered Retrospectively
Last Modified On: 28/02/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of exercise program on quality of life and hand function in type 2 diabetes mellitus with postmenopausal osteoporosis 
Scientific Title of Study   Effectiveness of structured exercise based rehabilitation program on quality of life and hand function in type 2 diabetes mellitus with postmenopausal osteoporosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shubha G 
Designation  Research scholar & PhD Scholar 
Affiliation  Manipal University 
Address  School of allied health sciences, Department of Physiotherapy, Manipal University, Madhav Nagar, Manipal
"Kamadhenu" Gundmi Sastan Post, Karnataka, Udupi 576226
Udupi
KARNATAKA
576104
India 
Phone  9620408222  
Fax  0802922609  
Email  s.gmaiya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Maiya 
Designation  Professor 
Affiliation  Manipal University 
Address  School of allied health sciences, Department of Physiotherapy, Manipal University, Madhav Nagar, Manipal
Madhav Nagar Manipal Udupi Taluk, District
Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax  0802922609  
Email  ajmaiya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubha G 
Designation  Research scholar 
Affiliation  Manipal University 
Address  School of allied health sciences, Department of Physiotherapy, Manipal University, Madhav Nagar, Manipal
"Kamadhenu" Gundmi Sastan Post, Karnataka, Udupi 576226
Udupi
KARNATAKA
576104
India 
Phone  9620408222  
Fax  0802922609  
Email  s.gmaiya@gmail.com  
 
Source of Monetary or Material Support  
School Of Allied Health Sciences, Manipal University, Manipal Campus, Madhav Nagar Pin 576104, Karnataka, Udupi Taluk and District 
 
Primary Sponsor  
Name  Manipal University 
Address  Department of Physiotherapy, School of allied health Sciences, Manipal-576104 
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 
Shubha G  Department Of Physiotherapy,Laser Clinic, Diabetic foot division, Kasturba Hospital Manipal  Department of Physiotherapy, Kasturba Hospital, Manipal-576104
Udupi
KARNATAKA 
9620408222
0802922609
s.gmaiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital, Manipal. Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 diabetes mellitus with postmenopausal osteoporosis without fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Routine medical care given by Physician 
Intervention  Study group  Structured exercises involving aerobic, weight bearing and hand exercises which will be given for the duration of 3 months with 5 times a week 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  type 2 diabetes mellitus with postmenopausal osteoporosis 
 
ExclusionCriteria 
Details  Neurological conditions, cardiological conditions 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Ultrasound on the forearm to measure bone mineral density
Prevalence of upper limb, deformities and conditions in people diagnosed with diabetes living in costal Karnataka, India
Level of Physical Activity (PA) in person with diabetes using GPAQ
Shoulder range of motion
Grip strength
Pinch strength
Sensory evaluation
Peg board test
Michigan Hand outcome Questionnaire (MHQ)Upper extremity function evaluation by DASH
Quality of life using SF-36 questionnaire 
to find the prevalence one time assessment of the primary outcome measure at the point of contact,

For intervention the outcome will be assessed pre intervention and post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Michigan Hand outcome Questionnaire (MHQ)Upper extremity function
evaluation by DASH
Shoulder ROM 
Baseline,
3 months after 
 
Target Sample Size   Total Sample Size="366"
Sample Size from India="366" 
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   Phase 1 
Date of First Enrollment (India)   13/01/2016 
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="3"
Months="5"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   No publication of the studies are done yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

In India there is high prevalence of type 2 Diabetes mellitus. Between 20-79 years of population 66.8 million people are living with type 2 Diabetes. Diabetes national prevalence in India is 8.63%. A study conducted to evaluate the hand functioning in patients with diabetes and its impact on quality of life (QoL) in the physical and mental dimensions suggested that impaired hand function affects lower acceptance of the disease, the occurrence of depression and reduced patient’s QoL. Studies have also shown that there is a high prevalence of upper limb and hand dysfunction in patients with type 2 Diabetes mellitus in India. South Indian postmenopausal osteoporosis women perform lesser physical activity compared to European women. It is well known from the literature that there is high prevalence of osteoporosis in postmenopausal women and also in women with type 2 diabetes mellitus in India. There is bone architectural changes and also bone loading changes are associated with type 2 diabetes. South Indian women with type 2 Diabetes mellitus had lesser bone mineral density compared to normal women. The current study focuses on estimation of prevalence of upper limb dysfunction and hand function in postmenopausal women with osteoporosis with type 2 Diabetes mellitus. Effect of upper limb and hand dysfunction on hand function and QoL will be measured. Effect of structured exercise based rehabilitation program on the hand function and QoL will be evaluated. If the participants improve with the intervention, structured exercises can be incorporated as part of  treatment while treating type 2 diabetes mellitus with postmenopausal osteoporosis

 
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