Exercise Training on Gait Pattern in Pregnancy

NCT05481983 | Unknown

• 1 other identifier: 22-4.1T/36
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

pregnancy; physiotherapy; gait analysis; clinical exercise; plantar pressure

Outcome Measures

Primary Outcomes (1)

• Foot plantar pressure

  A change in gait pattern will be observed with pregnancy

  8 weeks

Study Arms (2)

control group

OTHER

Walk exercise

Other: Walk exercise

study group

ACTIVE COMPARATOR

One-on-one clinical exercise training

Other: One-on-one clinical exercise training

Interventions

Walk exercise OTHER

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).

control group

One-on-one clinical exercise training OTHER

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.

study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-40
• No risk of pregnancy-related complications
• Between 12th and 24th weeks of pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Department of Sports Medicine

Izmir, Bornova, Turkey (Türkiye)

Location

Study Officials

• SEÇKİN ŞENIŞIK, Doktor

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The Randomization algorithm (Maximum Allowed % Deviation = 10%) was applied using PASS software 11.0 (NCSS LLC, Kaysville, UT) to generate a randomization list that would assign participants to two groups of 52 each.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, MSc.

Model Details: Randomized control, single-blind

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: August 1, 2022
• Study Start: May 1, 2022
• Primary Completion: February 27, 2023
• Study Completion: December 28, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

TU (1)