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NCT Number: NCT05195333

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The exercise program

Other

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.

Primary outcomes

  1. Pregnancy physical activity questionnaire for physical activity level measurement

    Time frame: 5 minutes

    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.

  2. HbA1c measurement

    Time frame: 10 minutes

    HbA1c values of the participants will be done in Medipol University laboratory.

  3. Fasting glucose measurements

    Time frame: 10 minutes

    Fasting glucose values of the participants will be done in Medipol University laboratory.

  4. World Health Organization Quality of life Short Form for measurement of quality of life

    Time frame: 5 minutes

    The scale measures physical, mental, social and environmental well-being and consists of 26 questions.

Secondary outcomes

  1. Weight measurement

    Time frame: 2 minutes

    Weight in kilogram will be measured with weighing machine

  2. Height measurement

    Time frame: 2 minutes

    Height in meters will be measured with tape measure

  3. Body mass index (BMI) measurement

    Time frame: 2 minutes

    Weight and height will be combined to report BMI in kg/m2

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2022
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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