| CTRI Number |
CTRI/2025/01/079649 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Impact of Concurrent Exercise Training on HbA1c, Lipid Profile, Body Composition, and Quality of Life in Adults with Type 2 Diabetes |
|
Scientific Title of Study
|
The effect of concurrent exercise training on Hba1c levels, Lipid Profile, Body Composition and Quality of Life in adults with Type 2 Diabetes. |
| 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 Yuthika Rao |
| Designation |
PhD Scholar |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Cardio Pulmonary Lab, Mahatma Gandhi Physiotherapy College, MGUMST, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9530096172 |
| Fax |
|
| Email |
dryuthikarao@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudan Tiwari |
| Designation |
Dean and Principal |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Dean and Principal Office, Mahatma Gandhi Physiotherapy College, MGUMST, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8290964159 |
| Fax |
|
| Email |
principal.physiotherapy@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhusudan Tiwari |
| Designation |
Dean and Principal |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Dean and Principal Office, Mahatma Gandhi Physiotherapy College, MGUMST, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8290964159 |
| Fax |
|
| Email |
principal.physiotherapy@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology,RIICO Institutional area, sitapura, tonk road, jaipur , Rajasthan,302022 |
|
|
Primary Sponsor
|
| Name |
Dr Yuthika Rao |
| Address |
6 62 , SFS, Agarwal Farm, Mansarovar, jaipur, Rajasthan,302022 |
| Type of Sponsor |
Other [Self] |
|
|
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 Madhusudan Tiwari |
Mahatma Gandhi Hospital |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi Institute of Medical Sciences and Technology,Sitapura RIICO Institutional Area, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
9530096172
principal.physiotherapy@mgumst.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Mahatma Gandhi Medical College and Hospital MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Aerobic Training (4 times/week) |
Group C
Aerobic Training which includes brisk walking for 30 minutes for 2 times per week continuously for 12 weeks |
| Intervention |
Concurrent Exercises |
Group A Resistance Training which is divided into upper limb resistance exercises and lower limb resistance exercises.
In Upper Limb Resistance training following are the exercises
Biceps Curl
Deltoid muscle
Shoulder Flexion Abduction and Extension
Triceps Triceps kickback
Straight Triceps lift Triceps Extension Single scarecrow
Lower limb resistance training are as follows
Quadriceps
Hamstrings
Soleus
Duration of the exercises is 2 times per week continuously for 12 weeks
Aerobic Training which includes brisk walking for 30 minutes for 2 times per week continuously for 12 weeks
|
| Comparator Agent |
Control Group |
Group D - Home Program
Active control group will provided standard care during their normal clinic visits to a consultant physician prescribing medication and general health education. There will be no specific instructions given or skills taught regarding exercise nor additional information regarding dietary modifications. The control group also had pre and post intervention measurements of all parameters and background physical activity measurements. This group of participants will contacted via telephone once every 2 weeks during the 12-week period and will met in the middle of the intervention (6-7 weeks). |
| Intervention |
Resistance Training |
Group B
Resistance Training which is divided into upper limb resistance exercises and lower limb resistance exercises. In Upper Limb Resistance training following are the exercises Biceps Curl
Deltoid muscle, Shoulder Flexion Abduction and Extension
Triceps, Triceps kickback Straight Triceps lift, Triceps Extension Single scarecrow
Lower limb resistance training are as follows
Quadriceps
Hamstrings
Soleus
Duration of the exercises is 2 times per week continuously for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Both Male & Female with age between 35yearto 65year.
Diagnosed with T2DM within last 10 years.
Blood HbA1c levels between 6.5% to 9.5%.
Patients referred only from Physician will be enrolled in the study.
|
|
| ExclusionCriteria |
| Details |
Patients who refused to participate in the study.
History of significant cardiovascular (ischemic heart disease etc.), respiratory (asthma chronic obstructive pulmonary disease etc.), musculoskeletal diseases (osteoarthritis of major joints etc.). People with cognitive impairment, intellectual disability, or mental illness pregnant women. Advanced diabetes induced end-stage organ damage (vascular, retinopathy, nephropathy, neuropathy, retinal hemorrhage or detachment, history of laser therapy).
Patients who are on injectable (insulin).
Patients on any current supervised exercise training program.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
HbA1c
Lipid Profile
Body Composition
QOL
|
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body Composition
Quality of Life |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="7"
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
|
Total 120 Subjects will be selected on the basis of selection criteria and will be divided in to FOUR (4) groups equally. Group A Resistance Training (2 times per week continuously for 12 weeks+ Aerobic Training (2 times per week continuously for 12 weeks) Group B Resistance Training (4 times/week) Group C Aerobic Training (4 times/week) Group D Control Group (usual) · Resisted Training Each exercise session will be for 30 -45 minutes in duration. Each session consisted of a warm-up, a resistance training component and a cool-down phase. · Aerobic Training This group followed a supervised progressive aerobic training program with exercise intensity developing up to 60–75% of heart rate max (HRmax). Subjects workload will be adjusted to achieve 60% of HRmax and 8-9 RPE for 20-30 minutes and then progressed to 75% of the HRmax and an RPE of 12-13 for up to 60 minutes. · Control group Active control group will provided standard care during their normal clinic visits to a consultant physician prescribing medication and general health education. There will be no specific instructions given or skills taught regarding exercise nor additional information regarding dietary modifications. The control group also had pre and post intervention measurements of all parameters and background physical activity measurements. This group of participants will contacted via telephone once every 2 weeks during the 12-week period and will met in the middle of the intervention (6-7 weeks). If participants wanted to exercise at home during the study or wanted to stop, they were excluded from the study . |