Effects of Telerehabilitation Exercise Program on Maternal Glycemic Control

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

Effects of Telerehabilitation Exercise Program on Maternal Antenatal Glycemic Control in Women With Gestational Diabetes.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452017
• Other study ID #: Maheen Haq
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Huma Riaz, PhD
• Phone: 03215242874
• Email: humarsh84[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

Other:
• 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.
• 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).

Locations

Country	Name	City	State
Pakistan	Pakistan Railway hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood sugar fasting	It is a diagnostic tool to assess person bloods sugar control and screen for diabetes and pre diabetes, is a fundamental measure of blood glucose levels in a fasting state, typically measured after an overnight fast. It provides insights into a person's current blood sugar status and is often used for diagnosing and monitoring diabetes.	Baseline to 2nd,4th,6th and 8th week
Primary	Blood sugar random	Random blood sugar, is a fundamental measure of blood glucose levels after a meal, it will be done 2 hours postprandial.	Baseline to 2nd,4th,6th and 8th week
Primary	HbA1c: Glycated hemoglobin	This test provides an estimate over average blood glucose level over past two to three months. It is a critical clinical marker used to assess long-term blood sugar control in individuals with diabetes. It measures the percentage of hemoglobin in the blood that has glucose attached to it.	Baseline to 12th week