Exercise Training on Gait Pattern in Pregnancy

NCT ID: NCT05481983

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-12-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control, single-blind
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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control group

Walk exercise

Group Type OTHER

Walk exercise

Intervention Type 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).

study group

One-on-one clinical exercise training

Group Type ACTIVE_COMPARATOR

One-on-one clinical exercise training

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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AYŞE KAYALI VATANSEVER

Physiotherapist, MSc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SEÇKİN ŞENIŞIK, Doktor

Role: STUDY_DIRECTOR

Ege University

Locations

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Ege University Department of Sports Medicine

Izmir, Bornova, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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22-4.1T/36

Identifier Type: -

Identifier Source: org_study_id

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