Comparison of Home Exercises and Home Exercise Pogram Taught by Physiotherapist in Women With Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Comparison of Home Exercises and Home Exercise Pogram Taught by Physiotherapist in Women With Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195333
• Other study ID #: Merveymz.
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants will be randomized and divided into 3 groups. The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. They do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. In the second group, the same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy. In the 3rd group, the participants will not be given any exercise program, they will be asked to continue their routine care.

Description:

45 pregnant women who applied to Çamlıca Medipol Hospital Gynecology and Obstetrics and were diagnosed with gestational diabetes will be included in the study. Being between the ages of 20-40, pregnancy of 26-30 weeks, being diagnosed with gestational diabetes as a result of oral glucose tolerance test, BMI>45 kg/m2, being physically inactive are inclusion criteria. Exclusion criteria are being younger than 18 years of age, having a history of Type 1 or Type 2 diabetes, having undergone bariatric surgery, using drugs that cause weight gain, and contraindications that prevent exercise. Participants will be randomized and divided into 3 groups. The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient. They do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy. In the second group, the same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy. In the 3rd group, the participants will not be given any exercise program, they will be asked to continue their routine care. Participants' fasting glucose and HbA1c values, anthropometric measurements, physical activity levels with the "pregnancy physical activity questionnaire (GFAA) and their quality of life with the World Health Organization Quality of Life Scale Short Form will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Being between 20-40 years old

• 26-30. week of pregnancy

• Diagnosis of gestational diabetes as a result of an oral glucose tolerance test

• BMI>45 kg/m2

• Being physically inactive

Exclusion Criteria:

• Being under the age of 18

• History of Type 1 or Type 2 diabetes

• Have had bariatric surgery

• Use of drugs that cause weight gain

• Contraindications preventing exercise

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• The exercise program
The exercise program prepared for the 1st group gestational diabetes will be explained to the pregnant women by the physiotherapist and the exercises will be taught to the patient.
• The exercise program
The same exercise program will be given to the participants only as a brochure and they will be asked to do 10 repetitions at home, 3 days a week, until the 34th week of pregnancy.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Downs DS, Dinallo JM, Birch LL, Paul IM, Ulbrecht JS. Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes. Psychol Sport Exerc. 2017 May;30:73-81. doi: 10.1016/j.psychsport.2017.02.003. Epub 2017 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy physical activity questionnaire for physical activity level measurement	It is a questionnaire that asks pregnant women to report their usual physical activities during the last month and questions the time spent with a total of 32 activities under the subheadings of housework/care activities, professional activities, sports/exercise.	5 minutes
Primary	HbA1c measurement	HbA1c values of the participants will be done in Medipol University laboratory.	10 minutes
Primary	Fasting glucose measurements	Fasting glucose values of the participants will be done in Medipol University laboratory.	10 minutes
Primary	World Health Organization Quality of life Short Form for measurement of quality of life	The scale measures physical, mental, social and environmental well-being and consists of 26 questions.	5 minutes
Secondary	Weight measurement	Weight in kilogram will be measured with weighing machine	2 minutes
Secondary	Height measurement	Height in meters will be measured with tape measure	2 minutes
Secondary	Body mass index (BMI) measurement	Weight and height will be combined to report BMI in kg/m2	2 minutes

External Links

•   Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes