Exercise Training on Gait Pattern in Pregnancy

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy
• Intervention / Treatment: Other: Walk exercise; Other: One-on-one clinical exercise training

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bornova
    • İzmir, Bornova, Turkey
      • Ege University Department of Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group; Walk exercise	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).
Active Comparator: study group; One-on-one clinical exercise training	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot plantar pressure	A change in gait pattern will be observed with pregnancy	8 weeks

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): February 27, 2023
• Study Completion (Anticipated): December 28, 2023

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; physiotherapy; gait analysis; plantar pressure; clinical exercise
• Other Study ID Numbers: 22-4.1T/36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No