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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05481983
Other study ID # 22-4.1T/36
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date December 28, 2023

Study information

Verified date February 2023
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The research will be conducted with healthy pregnant women who applied to the Ege University Gynecology and Obstetrics Department Polyclinic, and were referred to the Sports Medicine Department.The study will consist of two groups as the control group and the exercise group.Voluntary pregnant women who are not found to be inconvenient to do moderate-intensity exercise by the doctor will participate in the study.The study was planned as a randomized controlled and single-blind study.The participant's demographic information, obstetric assessment, physical activity level, fall history and pain assessment will be recorded.Foot plantar pressure, static and dynamic balance, center of pressure (COP), subtalar joint evaluation and gait evaluation will be measured by pedobarography at Ege University Orthopedics and Traumatology Department Gait Laboratory.The control group will be offered walking as recommended by ACOG for pregnant women.Clinical exercise training will be given to pregnant women in the study group by a specialist physiotherapist.


Description:

Pregnancy is a condition that includes many parameters.As the gestational week progresses and the fetus grows, changes are observed in the musculoskeletal system, hormonal system and other systems of the mother's body.Mechanical pain is observed in pregnant women with the expansion of the pelvis and the increase in the load on the lower extremities.The American Society of Obstetrics and Gynecology (ACOG) recommends physical activity and moderate-intensity exercises for a healthy pregnancy and delivery in pregnant women.Foot plantar pressure measurement is accepted in the literature as an objective measurement method in lower extremity biomechanical pain, static and dynamic balance.Evaluations will be made on day 0 and the day corresponding to the end of the 8th week.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 104
Est. completion date December 28, 2023
Est. primary completion date February 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Being between the ages of 18-40 - No risk of pregnancy-related complications - Between 12th and 24th weeks of pregnancy Exclusion Criteria: - History of lower extremity, pelvis or spine surgery - Pain in the lower extremity, pelvis, and spine that persists for more than 6 months - Any developmental delay related to the fetus

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Walk exercise
The control group will be recommended to walk 5 days a week, 30-45 minutes (min.) (at least 150 minutes of physical activity per week), as recommended by ACOG for pregnant women. Exercise intensity will be given as 4-6 units for moderate-intensity exercise according to the Modified Perceived Difficulty Level (RPE).
One-on-one clinical exercise training
One-on-one clinical exercise training will be given by a specialist physiotherapist who has received special training in antenatal exercise. The program is designed to be 2 days a week for 8 weeks.

Locations

Country Name City State
Turkey Ege University Department of Sports Medicine Izmir Bornova

Sponsors (1)

Lead Sponsor Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Foot plantar pressure A change in gait pattern will be observed with pregnancy 8 weeks
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