| CTRI Number |
CTRI/2025/12/098796 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Resistance training on Blood Glucose levels and other maternal outcomes in Females diagnosed with Gestational Diabetes Mellitus |
|
Scientific Title of Study
|
Impact of Resistance training on Blood Glucose levels, Gestational Weight Gain, Quality of Life and Fatigue in Females diagnosed with 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 |
Poorvi Mathur |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
SGT University Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana
170 Ganga Sagar Scheme Vaishali Nagar Jaipur
Jaipur
RAJASTHAN
122505
India |
| Phone |
9602652388 |
| Fax |
|
| Email |
piyu.mathur2407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Renuka Jakhar |
| Designation |
Assistant professor |
| Affiliation |
SGT University |
| Address |
SGT University Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8708330923 |
| Fax |
|
| Email |
renuka_sphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Poorvi Mathur |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
SGT University Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana
170 Ganga Sagar Scheme Vaishali Nagar Jaipur
Sirsa
RAJASTHAN
122505
India |
| Phone |
9602652388 |
| Fax |
|
| Email |
piyu.mathur2407@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Poorvi mathur |
| Address |
170 Gangasagar Scheme Vaishali Nagar Jaipur Rajasthan India
pincode 302021 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrRenuka Jakhar |
SGT University |
School of Physiotherapy, SGT University Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana
Gurgaon
HARYANA |
8708330923
renuka_sphy@sgtuniversity.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group-Gynaecologist advice followed |
No intervention given patient follows advice given by gynecologist |
| Intervention |
resistance training protocol |
Resisted exercises with wide BOS will be prescribed as well as resistance will be provided through body weight and resistance bands for 5 days a week 30 min a day for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
(1) those diagnosed with GDM, (2) age between 18 and 35years; (3) gestational age between 14 and 34 weeks (4) BMI-18.5-24.9kg/m2 (5) SF-12 questionnaire score for PCS below 50 and MCS score below 42 |
|
| ExclusionCriteria |
| Details |
(1) participation in other planned and supervised exercise programs or research activity during this research period (2) patients with severe obstetric contraindications and complications (3) patients with multiple foetus. (4) History of previous pre-term delivery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood Glucose levels
Gestational weight gain
Quality of Life
Fatigue levels
|
Baseline and after 4 weeks of intervention
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/12/2025 |
| 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="1"
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
|
Gestational diabetes is brought on by additional hormones released during pregnancy that can reduce the effectiveness of insulin, a condition known as insulin resistance, GDM is diagnosed in the second or third trimester of pregnancy. Placental hormones, such as human placental lactogen and placental growth hormone, cause a progressive development of insulin resistance in mother to provide the fetus with the adequate amount of glucose, Maternal hyperglycemia during pregnancy has deleterious at all stages of fetal development, increased risk of malformations. In the fetus, maternal diabetes leads to high birth weight and increased fat mass, including asphyxia, obstetrical trauma, respiratory distress and hypoglycemia. Exercise has its insulin sensitising effects by increasing sensitivity GLUT-4 to insulin and increased glycogen synthase, an increase in muscle mass through resistance training is associated with improved glycemic control, Resistance training influences blood glucose level, weight gain, QOL and fatigue in women diagnosed with gestational diabetes. Inclusion Criteria- those diagnosed with GDM, age between 18 and 35years; gestational age between 14 and 34 weeks Exclusion Criteria- participation in other planned and supervised exercise programs or research activity during this research period (2) patients with severe obstetric contraindications and complications, patients with multiple foetus, History of previous pre-term delivery. Participants will be selected from the Obstetrics and Gynecology Outpatient Department (OPD), The treatment protocol will consist of 30 minutes of exercise per day, 5 days a week, for a period of 4 weeks,Group A (Experimental): Participants will receive resistance training exercises to be performed on 5 days per week. Group B (Control): Participants will follow the instructions provided by their gynecologist for controlling GDM. Pre intervention data will be collected on recruitment in study and at the end of the 4th week, post-intervention measurements of the outcome variables will be taken. |