Effects of Telerehabilitation Exercise Program on Maternal Glycemic Control

June 11, 2025 updated by: Riphah International University

Effects of Telerehabilitation Exercise Program on Maternal Antenatal Glycemic Control in Women With Gestational Diabetes.

Gestational diabetes is in which high blood glucose concentration results from body's inability to create enough insulin to fulfil the needs of pregnancy. It appears in week between 24 to 28 and and raises the mothers and Childs risk of problems. It is thought to affect about 1 in 7 pregnancies worldwide. Through these remote exercise sessions the study evaluates the effectiveness of tele rehabilitation in improving glycemic management during pregnancy.The results will help clarify how telehealth intervention can best support GDM patient's maternal health outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Literature suggests that hormonal changes during pregnancy can interfere with insulin, the hormone that regulates blood glucose.This excess glucose can cross the placenta, affecting the developing fetus and increasing risks for both mother and child. The rising trends in obesity and advanced maternal age suggest that the prevalence of GDM will continue to increase.Approximately 7-10% of pregnancies worldwide are affected by gestational diabetes.Managing glucose levels is critical for women with gestational diabetes to ensure a healthy pregnancy and reduce the risk of complications for both mother and baby. Developing a positive attitude towards exercise is important for helping people with gestational diabetes manage their condition effectively through physical activity. The use of telerehabilitation may improve blood glucose levels in participants with GDM.

The control group will receive routine medical care and the experimental group will receive structured telerehabilitation exercise protocol. The results of both groups will be recorded and compared to assess the effectiveness of using telerehabilitation in the treatment of women with GDM in improving maternal blood glucose level.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 40100
        • Pakistan Railway Hospital
      • Rawalpindi, Punjab, Pakistan, 46000
        • AlKhidmat Razi Hospital,Rawalpindi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women aged 20 to 35 years
  • Gestational age between 20-28weeks
  • diagnosed with Gestational diabetes mellitus through oral glucose tolerance test (OGTT)
  • Primigravida and multigravida
  • able to do 6 6-minute walk tests under a severity level of 6 on the Borg scale of breathlessness.
  • Patients or caregivers have and able to use an electronic device (PC, tablet or smartphone)
  • Who signed informed consent

Exclusion Criteria:

  • Previously diagnosed T1DM or T2DM
  • High-risk pregnancy conditions contraindicating exercise as per ACOG guidelines
  • Patients taking insulin regularly.
  • Patients with fetal anomalies diagnosed at 20 th week.
  • Multiple gestation (twin or triplets)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: telerehabilitation exercise group
this group will receive a structured telerehabilitation exercise protocol of low to moderate intensity warm up ,aerobic ,resistance and cool down exercises for 3 times a week progressively increased for 8 weeks in addition to routine medical care for GDM.
Other: Telerehabilitation exercise program
5 min warmup will include ankle plantar and dorsiflexion ,trunk side flexion ,shoulder circles ,shoulder ROMS.it will be followed by 5 min aerobics that includes spot marching and side stepping. it will be followed by resistance exercise which will be divided into 3 groups. each group of exercise will be performed one day each. chair squats, arm pulls, seated triceps, biceps curls etc. are included in these resistance exercises. intensity of each exercise will be progressively increased.
Active Comparator: routine medical care
The control group will receive routine medical care including oral medication,diet and regular walk.
Other: Routine medical care
The control group will be given routine medical care (including dietary modification, oral anti diabetics (metformin) and advised to do regular walk (20-30min/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood sugar fasting
Time Frame: Baseline to 2nd,4th,6th and 8th week
It is a diagnostic tool to assess person bloods sugar control and screen for diabetes and pre diabetes, is a fundamental measure of blood glucose levels in a fasting state, typically measured after an overnight fast. It provides insights into a person's current blood sugar status and is often used for diagnosing and monitoring diabetes.
Baseline to 2nd,4th,6th and 8th week
Blood sugar random
Time Frame: Baseline to 2nd,4th,6th and 8th week
Random blood sugar, is a fundamental measure of blood glucose levels after a meal, it will be done 2 hours postprandial.
Baseline to 2nd,4th,6th and 8th week
HbA1c: Glycated hemoglobin
Time Frame: Baseline to 12th week
This test provides an estimate over average blood glucose level over past two to three months. It is a critical clinical marker used to assess long-term blood sugar control in individuals with diabetes. It measures the percentage of hemoglobin in the blood that has glucose attached to it.
Baseline to 12th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Huma Riaz, PhD, Riphah International University, Islamabad, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Maheen Haq

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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