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CompletedNCT06476730Updated Jun 12, 2025

Telerehabilitation Exercise: Effects on Maternal Psychological Health and Delivery Outcomes

An interventional study of Telerehabilitation exercise program and Routine medical care in Gestational Diabetes Mellitus in Pregnancy, Gestational Diabetes and Maternal Psychological Distress, sponsored by Riphah International University. Completed at 2 sites in Pakistan. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-12.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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.

Read the detailed description

The diagnosis of GDM can be unexpected and distressing, leading to feelings of sadness and hopelessness.Women with GDM are at a higher risk of experiencing prenatal and postnatal depression, which can affect their overall well-being and ability to care for their newborn. Regularly checking blood sugar levels, changing diet, and possibly using medication or insulin can be overwhelming. This constant effort and worry about complications can cause a lot of anxiety and stress. Many pregnant women with GDM might not fully understand how exercise can help control their blood sugar levels and improve their overall well-being. Developing a positive attitude towards exercise is important for helping people with gestational diabetes manage their condition effectively through physical activity. The use of telerehabilitation may improve psychological symptoms in participants with GDM.

The control group will receive routine medical care and the experimental group will receive 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 psychological health.

02

Conditions studied

  • Gestational Diabetes Mellitus in Pregnancy
  • Gestational Diabetes
  • Maternal Psychological Distress
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 62 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Telerehabilitation exercise group

    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

  • Active comparator
    Routine medical care

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

    Other: Routine medical care

Interventions

  • OtherTelerehabilitation exercise program

    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

  • OtherRoutine medical care

    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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: changes from baseline to 8th week

  2. 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.

    Time frame: changes from baseline to 8th week

Secondary outcomes

  1. Time of delivery

    Maternal delivery time in weeks will be noted.

    Time frame: At the time of delivery

  2. Mode of delivery

    Mode of delivery either vaginal or c-section will be noted.

    Time frame: At the time of delivery

  3. Incidence of instrumental delivery

    The incidence of instrumental delivery will be noted wither yes or no.

    Time frame: At the time of delivery

  4. Incidence of shoulder dystocia

    The incidence of shoulder dystocia will be noted wither yes or no.

    Time frame: At the time of delivery

07

Study locations

2 sites
  • Pakistan Railways Hospital
    Rawalpindi, Punjab 44000, Pakistan
  • AlKhidmat Razi Hospital,Rawalpindi
    Rawalpindi, Punjab 46000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06476730
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Jul 1, 2024
Primary completion
May 10, 2025
Completion
May 10, 2025
Last update
Jun 12, 2025

Study contacts

Huma Riaz, PhD
principal investigator · Riphah International University, Islamabad, Pakistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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