| CTRI Number |
CTRI/2024/07/071513 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To see the changes post electrical stimulation and resisted exercise on muscles strength, level of sugar and quality of life in type -II diabetic patients |
|
Scientific Title of Study
|
Effect of Neuromuscular Electrical Stimulation (NMES) and resisted exercise on muscle’s strength, blood glucose level and Quality Of Life (QOL) in individuals with type- II diabetes – An Experimental Study |
| 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. Jaykumar Soni (P.T.) |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth An Institution Deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth
An Institution Deemed to be University
At & Po. Piparia, Ta. Waghodia, Dist. Vadodara, Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
8866864021 |
| Fax |
|
| Email |
jds_1soni@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Neha Mukkamala |
| Designation |
Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth An Institution Deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth
An Institution Deemed to be University
At & Po. Piparia, Ta. Waghodia, Dist. Vadodara, Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
8866864021 |
| Fax |
|
| Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Jaykumar Soni (P.T.) |
| Designation |
Assocaite Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth An Institution Deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth
An Institution Deemed to be University
At & Po. Piparia, Ta. Waghodia, Dist. Vadodara, Gujarat, India
Vadodara
GUJARAT
391760
India |
| Phone |
8866864021 |
| Fax |
|
| Email |
jds_1soni@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Self funded project will be carried at ground floor room no 01 research lab of College of Physiotherapy, Sumandeep Vidyapeeth
An Institution Deemed to be University
At & Po. Piparia, Ta. Waghodia, Dist. Vadodara, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
DrJaykumar Soni |
| Address |
Ground floor room no 01 research lab of College of Physiotherapy, Sumandeep Vidyapeeth An Institution Deemed to be University At & Po. Piparia, Ta. Waghodia, Dist. Vadodara, Gujarat, India |
| 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 |
| DrJaykumar Soni |
Dhiraj Hospital |
Infront of Smt.B.K.Shah Medical Institute & Research Centre & Room No 01 Research lab, Dhiraj Hospital,College of Physiotherapy, sumandeep vidyapeeth deemed to be university,
AT & PO: PIPARIA,
WAGHODIA ROAD,
TA: WAGHODIA VADODARA 391760
Vadodara
GUJARAT |
8866864021
jds_1soni@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
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 |
| Comparator Agent |
Control Group |
In this group, the participants will be asked to continue their routine activities (exercise regimen, diet, yoga , meditation or any home remedies etc). Their base line data will be collected (muscles strength, blood glucose level and Quality of life) Post 4 weeks also the same data will be collected to see what changes will be seen in the same. |
| Comparator Agent |
Resisted exercise group |
In this group, the participants base line data (Blood glucose level, muscles strength and Quality of life). then they will be treated with Resisted Exercise The Protocol will be for 4 weeks, thrice in a day. Muscles strengthening will be done using weight cuffs with mild to moderate intensity of resistance. |
| Intervention |
Resisted exercise with Electrical stimulator |
In this group, the participants base line data (Blood glucose level, muscles strength and Quality of life). then they will be treated with Resisted Exercise and Electrical Stimulator. The Protocol will be for 4 weeks, thrice in a day. Muscles strengthening will be done using weight cuffs with mild to moderate intensity of resistance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with known or newly diagnosed with type-II diabetes
Both males and females
Subjects who are on oral hypoglycemic medicine
|
|
| ExclusionCriteria |
| Details |
Individuals with sensory deficit,
Gestational diabetes,
Musculoskeletal injuries and fracture in last 6 months,
Individuals with lower limb and/or upper limb amputation,
Medically unstable patients.
Individuals are on Insulin therapy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Muscles Strength, Fasting Blood Sugar level, Post postprandial blood sugar level- PP2BS, Quality of Life |
at the time of recruitment and at the end of four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscles Strength, Quality of Life, skeletal muscles mass |
at the time of recruitment and at the end of four weeks |
|
|
Target Sample Size
|
Total Sample Size="141"
Sample Size from India="141"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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="2"
Months="0"
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
|
This study is intend to see and compare the effect of resisted exercise vs resisted exercise and electrical stimulation. The participants will be screen and recruited in this study as per inclusion and exclusion criteria. randomly their allocation will be done. At the base line the outcome measures - Muscles strength, blood glucose level fasting and post prandial 2 hrs (PP2BS) and Quality of life will be assessed. The participants will be divided into three groups by the randomization lottery method. In resisted exercise group, subjects will be given resisted exercise thrice in a week for four weeks. In Resisted exercise and Electrical stimulation group, the participants will be given resisted exercise (same as resisted exercise group) and electrical stimulation for thrice in a week for four weeks. In the control group they will be given no intervention but their routine activities will be recorded.
|