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NCT Number: NCT06476730

Telerehabilitation Exercise: Effects on Maternal Psychological Health and Delivery Outcomes

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.

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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Maternal Psychological Distress Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

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

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.

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 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

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

    Time frame: changes from baseline to 8th week

    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.

  2. Strait trait anxiety inventory (STAI)

    Time frame: changes from baseline to 8th week

    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.

Secondary outcomes

  1. Time of delivery

    Time frame: At the time of delivery

    Maternal delivery time in weeks will be noted.

  2. Mode of delivery

    Time frame: At the time of delivery

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

  3. Incidence of instrumental delivery

    Time frame: At the time of delivery

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

  4. Incidence of shoulder dystocia

    Time frame: At the time of delivery

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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Telerehabilitation Exercise Program on Psychological Health and Delivery Outcomes in Women With Gestational Diabetes Mellitus.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 26, 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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