Telerehabilitation Exercise: Effects on Maternal Psychological Health and Delivery Outcomes

NCT ID: NCT06476730

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-05-10

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Telerehabilitation exercise program

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Routine medical care

Intervention Type: 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).

Interventions

Telerehabilitation 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

Intervention Type: OTHER

Routine 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).

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huma Riaz, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University, Islamabad, Pakistan

Locations

Pakistan Railways Hospital

Rawalpindi, Punjab Province, Pakistan

AlKhidmat Razi Hospital,Rawalpindi

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Muzna Haq

Identifier Type: -

Identifier Source: org_study_id