Clinical trial NCT06480292: Telerehabilitation Exercise: Effects on Maternal Quality of Life, Fetal and Neonatal Health.
Official title: Effects of Telerehabilitation Exercise Program on Maternal Quality of Life, Fetal and Neonatal Health Outcomes in Women With Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a comparison between two groups; experimental and control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: GDMQ-36 for Maternal Quality of Life
timeFrame: changes from baseline to 8th week
Secondary outcomes:
measure: Fetal Health
timeFrame: changes from baseline to 8th week
measure: Neonatal Health
timeFrame: At the time of delivery
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railways Hospital
state: Punjab
city: Rawalpindi
country: Pakistan
facility: AlKhidmat Razi Hospital,Rawalpindi
state: Punjab
Study officials:
affiliation: Riphah International University, Islamabad, Pakistan
name: Huma Riaz, PhD
role: PRINCIPAL_INVESTIGATOR
References: