Exercise Training on Gait Pattern in Pregnancy

Pregnancy Clinical Trial

Official title:

the Effect of Clinical Exercise Training on Foot Plantar Pressure, Subtalar Joint and Gait Patterns in Pregnancy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05481983
• Other study ID #: 22-4.1T/36
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pregnancy

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