Clinical trial NCT06452017: Effects of Telerehabilitation Exercise Program on Maternal Glycemic Control
Official title: Effects of Telerehabilitation Exercise Program on Maternal Antenatal Glycemic Control in Women With Gestational Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: there will be comparison between the two groups, experimental and control
Primary purpose: TREATMENT

Brief summary: Gestational diabetes is in which high blood glucose concentration results from body's inability to create enough insulin to fulfil the needs of pregnancy. It appears in week between 24 to 28 and and raises the mothers and Childs risk of problems. It is thought to affect about 1 in 7 pregnancies worldwide. Through these remote exercise sessions the study evaluates the effectiveness of tele rehabilitation in improving glycemic management during pregnancy.The results will help clarify how telehealth intervention can best support GDM patient's maternal health outcomes.

Detailed description: Literature suggests that hormonal changes during pregnancy can interfere with insulin, the hormone that regulates blood glucose.This excess glucose can cross the placenta, affecting the developing fetus and increasing risks for both mother and child. The rising trends in obesity and advanced maternal age suggest that the prevalence of GDM will continue to increase.Approximately 7-10% of pregnancies worldwide are affected by gestational diabetes.Managing glucose levels is critical for women with gestational diabetes to ensure a healthy pregnancy and reduce the risk of complications for both mother and baby. 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 blood glucose levels 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 maternal blood glucose level.

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)

Primary outcomes:
measure: Blood sugar fasting
timeFrame: Baseline to 2nd,4th,6th and 8th week
measure: Blood sugar random
timeFrame: Baseline to 2nd,4th,6th and 8th week
measure: HbA1c: Glycated hemoglobin
timeFrame: Baseline to 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway hospital
state: Punjab
city: Rawalpindi
country: Pakistan
facility: AlKhidmat Razi Hospital,Rawalpindi
state: Punjab
Study officials:
affiliation: Riphah International University, Islamabad, Pakistan
name: Huma Riaz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munoz-Tomas MT, Burillo-Lafuente M, Vicente-Parra A, Sanz-Rubio MC, Suarez-Serrano C, Marcen-Roman Y, Franco-Sierra MA. Telerehabilitation as a Therapeutic Exercise Tool versus Face-to-Face Physiotherapy: A Systematic Review. Int J Environ Res Public Health. 2023 Feb 28;20(5):4358. doi: 10.3390/ijerph20054358.
citation: Bung P, Artal R, Khodiguian N. [Regular exercise therapy in disorders of carbohydrate metabolism in pregnancy--results of a prospective, randomized longitudinal study]. Geburtshilfe Frauenheilkd. 1993 Mar;53(3):188-93. doi: 10.1055/s-2007-1023663. German.
citation: Stafne SN, Salvesen KA, Romundstad PR, Eggebo TM, Carlsen SM, Morkved S. Regular exercise during pregnancy to prevent gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):29-36. doi: 10.1097/AOG.0b013e3182393f86.
citation: Tobias DK, Zhang C, van Dam RM, Bowers K, Hu FB. Physical activity before and during pregnancy and risk of gestational diabetes mellitus: a meta-analysis. Diabetes Care. 2011 Jan;34(1):223-9. doi: 10.2337/dc10-1368. Epub 2010 Sep 27.