Telerehabilitation Exercise: Effects on Maternal Psychological Health and Delivery Outcomes

Not Applicable

Recruiting

• Conditions: Gestational Diabetes Mellitus in Pregnancy; Gestational Diabetes; Maternal Psychological Distress
• Interventions: Other: Telerehabilitation exercise program; Other: Routine medical care

• Registration Number: NCT06476730
• Lead Sponsor: Riphah International University

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.

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.

Study Timeline

• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-26
• Status Verified: 2024-07
• Study Start: 2024-07-01
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telerehabilitation exercise group	Telerehabilitation exercise program	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.
Routine medical care	Routine medical care	The control group will receive routine medical care including oral medication, diet and regular walk.

Primary Outcome Measures

Name	Time	Method
Strait trait anxiety inventory (STAI)	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.
Center of Epidemiologic studies depression scale (CES-D)	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of instrumental delivery	At the time of delivery	The incidence of instrumental delivery will be noted wither yes or no.
Time of delivery	At the time of delivery	Maternal delivery time in weeks will be noted.
Mode of delivery	At the time of delivery	Mode of delivery either vaginal or c-section will be noted.
Incidence of shoulder dystocia	At the time of delivery	The incidence of shoulder dystocia will be noted wither yes or no.

Trial Locations

Locations (2)

Pakistan Railways Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan

AlKhidmat Razi Hospital,Rawalpindi; 🇵🇰 Rawalpindi, Punjab, Pakistan