Effects of Telerehabilitation Exercise Program on Maternal Glycemic Control

Not Applicable

Recruiting

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Other: Telerehabilitation exercise program; Other: Routine medical care

• Registration Number: NCT06452017
• Lead Sponsor: Riphah International University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-05
• Study Start: 2024-06-10
• Study First Posted: 2024-06-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telerehabilitation exercise group	Telerehabilitation exercise program	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.
routine medical care	Routine medical care	The control group will receive routine medical care including oral medication,diet and regular walk.

Primary Outcome Measures

Name	Time	Method
HbA1c: Glycated hemoglobin	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.
Blood sugar fasting	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.
Blood sugar random	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.

Trial Locations

Locations (2)

AlKhidmat Razi Hospital,Rawalpindi; 🇵🇰 Rawalpindi, Punjab, Pakistan

Pakistan Railway hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan