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

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The exercise program
The exercise program
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring gestational diabetes, home exercise, physiotherapist

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

First group

Second group

Third group

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.
HbA1c measurement
HbA1c values of the participants will be done in Medipol University laboratory.
Fasting glucose measurements
Fasting glucose values of the participants will be done in Medipol University laboratory.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 30, 2021
Last Updated
July 3, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05195333
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
gestational diabetes, home exercise, physiotherapist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will not know which group to belong to.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First group
Arm Type
Experimental
Arm Description
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.
Arm Title
Second group
Arm Type
Experimental
Arm Description
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
Arm Title
Third group
Arm Type
No Intervention
Arm Description
The participants will not be given any exercise program, they will be asked to continue their routine care.
Intervention Type
Other
Intervention Name(s)
The exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pregnancy physical activity questionnaire for physical activity level measurement
Description
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.
Time Frame
5 minutes
Title
HbA1c measurement
Description
HbA1c values of the participants will be done in Medipol University laboratory.
Time Frame
10 minutes
Title
Fasting glucose measurements
Description
Fasting glucose values of the participants will be done in Medipol University laboratory.
Time Frame
10 minutes
Title
World Health Organization Quality of life Short Form for measurement of quality of life
Description
The scale measures physical, mental, social and environmental well-being and consists of 26 questions.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Weight measurement
Description
Weight in kilogram will be measured with weighing machine
Time Frame
2 minutes
Title
Height measurement
Description
Height in meters will be measured with tape measure
Time Frame
2 minutes
Title
Body mass index (BMI) measurement
Description
Weight and height will be combined to report BMI in kg/m2
Time Frame
2 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on self-representation of gender identity.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MERVE YILMAZ MENEK
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I will publish an article about the results of the study and share it with other researchers.
Citations:
PubMed Identifier
28428728
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/28428728/
Description
Randomized Face-to-Face vs. Home Exercise Interventions in Pregnant Women with Gestational Diabetes

Learn more about this trial

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

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