| 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
|
|
|
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
|
|
|
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 |