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

NCT05195333 | Completed

• 1 other identifier: Merveymz.
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

gestational diabetes; home exercise; physiotherapist

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Weight measurement

  2 minutes

• Height measurement

  2 minutes

• Body mass index (BMI) measurement

  2 minutes

Study Arms (3)

First group

EXPERIMENTAL

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

Second group

EXPERIMENTAL

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

Third group

NO INTERVENTION

The participants will not be given any exercise program, they will be asked to continue their routine care.

Interventions

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.

First group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being between 20-40 years old
• week of pregnancy
• Diagnosis of gestational diabetes as a result of an oral glucose tolerance test
• BMI\>45 kg/m2
• Being physically inactive

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 28428728 RESULT

• Menek MY, Kaya AK. Comparison of home exercise under supervision and self home exercise in pregnant women with gestational diabetes: randomized controlled trial. Arch Gynecol Obstet. 2024 Mar;309(3):1075-1082. doi: 10.1007/s00404-023-07339-4. Epub 2024 Jan 6.

  PMID: 38184491 DERIVED

Related Links

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

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Officials

• MERVE YILMAZ MENEK

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which group to belong to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 18, 2022
• Study Start: February 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)