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

NCT06480292 | Completed

• 1 other identifier: Ghazal Fatima
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• GDMQ-36 for Maternal Quality of Life

  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.

  changes from baseline to 8th week

Secondary Outcomes (2)

• Fetal Health

  changes from baseline to 8th week

• Neonatal Health

  At the time of delivery

Study Arms (2)

Telerehabilitation exercise program

EXPERIMENTAL

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.

Other: telerehabilitation exercise

Routine medical care

ACTIVE COMPARATOR

The control group will receive routine medical care including oral medication (metformin), dietry precautions and advised to do regular walk for 20-30minutes.

Other: routine medical care

Interventions

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.

Telerehabilitation exercise program

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).

Routine medical care

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Pakistan Railways Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

AlKhidmat Razi Hospital,Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Officials

• Huma Riaz, PhD

  Riphah International University, Islamabad, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a comparison between two groups; experimental and control group.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 28, 2024
• Study Start: July 1, 2024
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)