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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: The exercise program; Other: The exercise program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First group; 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. You will be asked to do these exercises as home exercise with 10 repetitions 3 days a week, until the 34th week of pregnancy.	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.; Other: 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.
Experimental: 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	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.; Other: 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.
No Intervention: Third group; The participants will not be given any exercise program, they will be asked to continue their routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
HbA1c measurement	HbA1c values of the participants will be done in Medipol University laboratory.	10 minutes
Fasting glucose measurements	Fasting glucose values of the participants will be done in Medipol University laboratory.	10 minutes
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight measurement	Weight in kilogram will be measured with weighing machine	2 minutes
Height measurement	Height in meters will be measured with tape measure	2 minutes
Body mass index (BMI) measurement	Weight and height will be combined to report BMI in kg/m2	2 minutes

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: MERVE YILMAZ MENEK, Medipol University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: gestational diabetes; home exercise; physiotherapist
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: Merveymz.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I will publish an article about the results of the study and share it with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No