Telerehabilitation Exercise: Effects on Maternal Psychological Health and Delivery Outcomes

NCT06476730 | Completed

• 1 other identifier: Muzna Haq
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

Gestational diabetes occurs when the body can't make enough insulin to manage high blood sugar during pregnancy, usually developing between the 24th and 28th weeks. It affects about 14% of pregnancies worldwide. Women with gestational diabetes often feel more anxious and stressed and have a higher risk of depression during and after pregnancy. This study will explore how telerehabilitation can reduce anxiety and depression and show how exercise can improve the health of pregnant women with gestational diabetes.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Gestational Diabetes; Maternal Psychological Distress

Outcome Measures

Primary Outcomes (2)

• Center of Epidemiologic studies depression scale (CES-D)

  The CES-DC is an inventory of 20 self-report items regarding depressive symptoms, taking about 5 minutes to completeIn scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.

  changes from baseline to 8th week

• Strait trait anxiety inventory (STAI)

  It is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale.The total score ranges from 0-63.The following guidelines are recommended for the interpretation of scores: 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.

  changes from baseline to 8th week

Secondary Outcomes (4)

• Time of delivery

  At the time of delivery

• Mode of delivery

  At the time of delivery

• Incidence of instrumental delivery

  At the time of delivery

• Incidence of shoulder dystocia

  At the time of delivery

Study Arms (2)

Telerehabilitation exercise group

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) in addition to routine medical care for GDM.

Other: Telerehabilitation exercise program

Routine medical care

ACTIVE COMPARATOR

The control group will receive routine medical care including oral medication, diet and regular walk.

Other: Routine medical care

Interventions

Telerehabilitation exercise program 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 group

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

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: There will be two groups, experimental and control

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 26, 2024
• Study Start: July 1, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 10, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)