Clinical trial NCT05195333: Comparison of Home Exercises and Home Exercise Pogram Taught by Physiotherapist in Women With Gestational Diabetes
Official title: Comparison of Home Exercises and Home Exercise Pogram Taught by Physiotherapist in Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational diabetes
home exercise
physiotherapist
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy physical activity questionnaire for physical activity level measurement
timeFrame: 5 minutes
measure: HbA1c measurement
timeFrame: 10 minutes
measure: Fasting glucose measurements
timeFrame: 10 minutes
measure: World Health Organization Quality of life Short Form for measurement of quality of life
timeFrame: 5 minutes
Secondary outcomes:
measure: Weight measurement
timeFrame: 2 minutes
measure: Height measurement
timeFrame: 2 minutes
measure: Body mass index (BMI) measurement
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: MERVE YILMAZ MENEK
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.