| CTRI Number |
CTRI/2016/11/007488 [Registered on: 24/11/2016] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness Of Exercise Program in Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
effectiveness of structured exercise program on insulin resistance and quality of life in type 2 diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASampath kumar |
| Designation |
Ph.D Scholar |
| Affiliation |
Manipal university |
| Address |
c/o Department of Physiotherapy,
SOAHS, Manipal University.
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
sampathkpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun G Maiya |
| Designation |
proffessor |
| Affiliation |
Manipal university |
| Address |
c/o Department of Physiotherapy,
SOAHS, Manipal University.
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
ajmaiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASampath kumar |
| Designation |
Ph.D Scholar |
| Affiliation |
Manipal university |
| Address |
c/o Department of Physiotherapy,
SOAHS, Manipal University.
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
sampathkpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of physiotherapy, school of allied health sciences, Manipal University Manipal University |
|
|
Primary Sponsor
|
| Name |
Manipal University |
| Address |
project diabetic foot care, department of physiotherapy, school of allied health sciences, Manipal University Manipal,Karnataka,India |
| 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 |
| Dr A Sampathkumar |
kasturba hospital |
c/o Department of Physiotherapy,
School of Allied Health Sciences, Manipal University
Udupi
KARNATAKA |
8105819191
sampathkpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
in this participants will be given standard medical care which is given by the physician |
| Intervention |
structured exercises |
in the intervention group they will be given structured exercises like aerobic and resistance exercises twice a day i.e morning and evening and duration of exercise is one hour in a day |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
participants with type diabetes mellitus on oral hypoglycemic agent with or without insulin theray |
|
| ExclusionCriteria |
| Details |
participants with type 1 diabetes mellitus,
pregnancy, thyroid disorder |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| fasting insulin level, HOMA-IR, six minute walk test, quality of life by WHOQOL-BREF. |
baseline and at 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fasting blood sugar,body composition analysis, HbA1c, Physical activity using GPAQ questionnaire. |
baseline and at 3rd month |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2016 |
| Date of Study Completion (India) |
30/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: People living with the type 2 diabetes is increasing alarmingly in India. In literature much attention given towards diabetic foot and its management and less focus is devoted to Diabetes affecting on physical activity and strength. Literature gap: Very few RCT`s with smaller sample size were available in the literature globally. Even though prevalence of T2DM increasing rapidly in Indian population there is a dearth of literature on exercise training on insulin resistance in T2DM. Need for the Project: Even though the prevalence of diabetes mellitus is increasing in India, focus is on management of hyperglycemia and subsequent complications. Based on the literature we observed even though till date T2DM is highly prevalent & develops IR, there are only few studies available with the effectiveness of exercise on IR which leads to an exercise intolerance in T2DM, which reduces function & altered quality of life which one again had influence on glycemic control.Therefore there is a need to study the exercise intolerance in T2DM There is dearth of literature on combined aerobic and resistance training on insulin resistance in type 2 diabetes mellitus in Indian population. |