| CTRI Number |
CTRI/2024/04/066556 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Exercise in gestational diabetes mellitus |
|
Scientific Title of Study
|
Effects of functional resistance training over blood glucose level in gestational diabetes mellitus. |
| 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 Harrini S |
| Designation |
MPT womens health |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Sri Ramachandra institute of higher education and research Department of physiotherapy
No1 Ramachandra nagar
porur
Chennai
TAMIL NADU
600116
India |
| Phone |
7871774238 |
| Fax |
|
| Email |
t0522002@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Ponmathi P |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Sri Ramachandra institute of higher education and research
Faculty of physiotherapy department
No1 Ramachandra nagar
porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MS Ponmathi P |
| Designation |
Assistant professor |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Sri Ramachandra institute of higher education and research
Faculty of physiotherapy department
No1 Ramachandra nagar
porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research
faculty of physiotherapy department
No 1 Ramachandra nagar
porur
chennai 600116 |
|
|
Primary Sponsor
|
| Name |
Dr Harrini S |
| Address |
Faculty of physiotherapy department
No1 Ramachandra nagar
porur
chennai 600116 |
| Type of Sponsor |
Other [self funding] |
|
|
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 Harrini S |
Sri Ramachandra institute of higher education and research |
faculty of physiotherapy department
N01 Ramachandra nagar
porur
chennai 600116
Chennai
TAMIL NADU |
7871774238
t0522002@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gestational Diabetes Mellitus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Functional resistance training |
Front squat, overhead press, bent row, trunk twist, side step squat, chest raise, dumbbell row.Duration:30 minutes. |
| Comparator Agent |
Routine antenatal care |
Gestational knowledge and knowledge of diabetes diet, new born breast feeding, insulin injection methods. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Complete cognitive and behavioral abilities
Age more or equal to 20 years
Women s with gestational diabetes mellitus
Gestational stage from 24 weeks
BMI lower than 40kg/m2
|
|
| ExclusionCriteria |
| Details |
cardiac diseases
restrictive lung diseases
second or third trimester bleeding
ruptured membrane
pre eclampsia
severe anemia and history of abortion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood glucose level |
pre and post the intervention of 12weeks duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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 2 |
|
Date of First Enrollment (India)
|
07/05/2024 |
| 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="0"
Months="6"
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
|
Based on the inclusion and criteria women with gestational diabetes mellitus volunteering in this program will be screened from Sri Ramachandra hospital from obstetrics and Gynaecology department subjects will be randomly divided into 2 groups. Group A (Experimental) FUNCTIONAL RESISTANCE TRAINING Group B (Control) ROUTINE ANTENATAL CARE
The exercise program consist of 5 mins of warmup and 5 mins of cool down. After pre and post intervention of 12 weeks duration subjects in both group A and B will be assessed by blood glucose level. |