The Effect of Circuit Exercise Program in Gestational Diabetes

NCT ID: NCT05096078

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-16
• Study Completion Date: 2022-06-30

Brief Summary

Gestational diabetes (GDM) is defined as 'pregnancy-onset or first noticed glucose intolerance'. The aim of this study is to investigate the effect of circuit exercise program applied in addition to diet therapy on cognitive function, functional exercise capacity, mobility, depression and quality of life in women with gestational diabetes. 60 female participants between the ages of 18-35 who meet the inclusion criteria will be included in the study. Participants will be randomly divided into 2 groups as diet group (n=30) and exercise group (n=30). All participants will receive GDM-specific dietary therapy for 6 weeks. In addition to diet therapy, individuals in the exercise group will be given a circuit exercise program for 6 weeks. Participants will be evaluated for blood values, cognitive status and functionality at the baseline and 6 weeks later.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Diet Group

Individuals will receive only dietary treatment that the dietitian deems appropriate for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Diet

Intervention Type: OTHER

Special diet program for gestational diabetes

Exercise Group

In addition to the 6-week diet program that the dietitian deems appropriate, a circuit exercise program will be applied for 6 weeks. The circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests.

Group Type: EXPERIMENTAL

Diet

Intervention Type: OTHER

Special diet program for gestational diabetes

Exercise

Intervention Type: OTHER

The circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests.

Interventions

Diet

Special diet program for gestational diabetes

Intervention Type: OTHER

Exercise

The circuit exercise program will consist of a medium-intensity circuit training for 50 minutes, 3 days a week, detailing the main muscle groups of the patients (chest, back, biceps, triceps, deltoid, quadriceps, thigh and calf muscles). Exercise intensity will be monitored using Borg's scale of perceived exertion, with a target intensity of 12 to 14. 8 exercises will be given in a continuous, circuit-type manner with short 1-minute rests.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• being diagnosed with gestational DM
• being between the ages of 18-35
• being in 24-32 weeks of pregnancy
• being inactive physical activity level - (<300 MET weeks/day)

Exclusion Criteria

• Diagnosed with diabetes before pregnancy
• have given birth before
• Multiple Pregnancy (>2)
• Intrauterine growth restriction
• Preeclampsia
• having high risk of preterm labor and on strict bed rest
• treatment with insulin or oral hypoglycemic agents during pregnancy
• Other significant severe or poorly controlled medical conditions (thyroid disease, cardio-respiratory disorders, ...)
• taking medications that affect cognitive function, including corticosteroids, anti-depressants, or anti-epileptics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Miray Budak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miray BUDAK, PhD

Role: STUDY_DIRECTOR

Medipol University

Saadet Turhan

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GestationalDM.Exer.Cog.

Identifier Type: -

Identifier Source: org_study_id