Telerehabilitation Exercise: Effects on Maternal Quality of Life, Fetal and Neonatal Health.

Not Applicable

Recruiting

• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Interventions: Other: routine medical care; Other: telerehabilitation exercise

• Registration Number: NCT06480292
• Lead Sponsor: Riphah International University

Brief Summary

Gestational diabetes mellitus (GDM) occurs when blood sugar levels rise during pregnancy, typically between 24-28 weeks, affecting about 2-18% of all pregnancies. It is a common metabolic disease that can lead to health risks for the mother, fetus, and child, and can negatively impact the mother's quality of life. This study aims to explore how a telerehabilitation exercise program affects the quality of life of mothers with GDM and the health of fetus/neonate.

Detailed Description

Gestational diabetes mellitus (GDM) significantly impacts maternal quality of life (QoL) and fetal/neonatal health. According to the World Health Organization, quality of life (QOL) is a person's view of their status in life within their culture and value system. Pregnancies with GDM, negatively affect personal, familial, and social life, leading to poorer QOL. GDM causes medical issues for the mother and fetus and harms the mother's psychological well-being, reducing her QOL. Due to the increasing prevalence of GDM and the importance of improving QOL for affected women, this study examines impact of telerehabilitation exercise on quality of life of pregnant women. Awareness about the importance of exercise in managing gestational diabetes mellitus (GDM) is crucial. Regular physical activity can help control blood sugar levels, reduce insulin resistance, and improve overall health for both the mother and fetus leading to better pregnancy outcomes.Telerehabilitation offers convenience, accessibility, and personalized support, allowing patients to exercise from home with continuous healthcare provider monitoring.It is a cost-effective, flexible, and safer alternative to traditional exercise methods, especially beneficial for managing gestational diabetes.

The control group will recieve routine medical care and the experimental group will recieve 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 their quality of life.

Study Timeline

• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-28
• Status Verified: 2024-07
• Study Start: 2024-07-01
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

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
Routine medical care	routine medical care	The control group will receive routine medical care including oral medication (metformin), dietry precautions and advised to do regular walk for 20-30minutes.
Telerehabilitation exercise program	telerehabilitation exercise	This group will receive a structured tele rehabilitation 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. along with routine medical care will be provided.

Primary Outcome Measures

Name	Time	Method
GDMQ-36 for Maternal Quality of Life	changes from baseline to 8th week	The GDMQ (Gestational Diabetes Mellitus Quality of Life)-36 is a simple, valid, and reliable tool for assessing the quality of life of women with GDM across five domains: Emotional, Physical, Social, Self-Efficacy, and Healthcare. Each domain includes multiple items rated on a 5-point Likert scale (strongly agree to strongly disagree) with a score range of 1 to 5. Domain scores are calculated by summing the responses for each item, and the total GDMQ score is the sum of all domain scores. Higher scores generally indicate better quality of life if the scale is positively oriented. This tool helps identify areas needing intervention and support, offering a comprehensive measure of GDM-related quality of life.

Secondary Outcome Measures

Name	Time	Method
Fetal Health	changes from baseline to 8th week	Fetal Health measured by fetal obstetric ultrasound and anomaly scan.
Neonatal Health	At the time of delivery	Neonatal outcome measured by examination and pediatric records.

Trial Locations

Locations (2)

Pakistan Railways Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan

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