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Completed

NCT Number: NCT06480292

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AlKhidmat Razi Hospital,Rawalpindi, Rawalpindi, Punjab Province, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

telerehabilitation exercise

Other

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.

Routine medical care

Other

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).

Primary outcomes

  1. GDMQ-36 for Maternal Quality of Life

    Time frame: 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 outcomes

  1. Fetal Health

    Time frame: changes from baseline to 8th week

    Fetal Health measured by fetal obstetric ultrasound and anomaly scan.

  2. Neonatal Health

    Time frame: At the time of delivery

    Neonatal outcome measured by examination and pediatric records.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Telerehabilitation Exercise Program on Maternal Quality of Life, Fetal and Neonatal Health Outcomes in Women With Gestational Diabetes Mellitus

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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