NCT05720403

Brief Summary

Pregnancy is a physiological stress state that affects all body systems and requires physical, mental, and social harmony in the woman. The pregnancy process continues with visible changes in the female body and psychological changes and fluctuations. The mental and physical adaptation of the mother to the changes that occur during pregnancy can be increased by interventions that can be done in this process. Exercises are at the top of these interventions. Exercise has been shown to affect the fetus, mother, and pregnancy positively. In the guide published by the American Obstetricians and Gynecologists Committee in 2015, It was stated that pregnant women should exercise at least half an hour of moderate-intensity on most days of the week. They also recommended exercises such as Pilates, yoga, and swimming as safe activities for pregnant women. Pilates exercises are ideal for preparing the pregnant woman's body until birth, and after birth plays a vital role in the recovery of the mother's body. Above all, it makes women feel more comfortable in this temporary body and makes them more active. When the literature is examined, it is seen that studies which include the effects of Pilates during pregnancy are still insufficient All of these studies examining the effects of Pilates education on pregnant women show us that Pilates education can positively contribute to pregnant women. However, in all studies, it is stated that the effects of Pilates on different dimensions of pregnancy should be examined, and additional studies with high evidence value are needed. Based on this, to ensure that pregnant women have a healthier and more comfortable pregnancy period, a randomized controlled blind study was planned to investigate the effects of Pilates training on core stability, balance, mood, and quality of life in pregnant women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

January 31, 2023

Last Update Submit

February 12, 2023

Conditions

Keywords

Pilates exercisesPregnantMoodCore

Outcome Measures

Primary Outcomes (8)

  • Core Stability Test- Baseline

    Sahrman Core Stability Test

    Assessment will be conducted before the intervention

  • Core Stability Test-Post intervention

    Sahrman Core Stability Test

    Assessment will be conducted immediately after the intervention

  • Balance - Baseline

    Balance was evaluated using the Biodex-BioSway™ (Biodex Medical Systems, Shirley, NY, USA) Portable Balance System

    Assessment will be conducted before the intervention

  • Balance - Post intervention

    Balance was evaluated using the Biodex-BioSway™ (Biodex Medical Systems, Shirley, NY, USA) Portable Balance System

    Assessment will be conducted immediately after the intervention

  • Quality of life - Baseline

    Short Form-36 (SF-36). SF-36; consists of 36 items to measure eight dimensions such as physical, mental, and general health. In the subscales evaluated between 0 and 100, a high score indicates a good quality of life.

    Assessment will be conducted before the intervention

  • Quality of life - Post intervention

    Short Form-36 (SF-36). SF-36; consists of 36 items to measure eight dimensions such as physical, mental, and general health. In the subscales evaluated between 0 and 100, a high score indicates a good quality of life.

    Assessment will be conducted immediately after the intervention

  • Fear of Birth- Baseline

    The Wijma Birth Expectation/Experience Scale was developed to measure the nature of the fear of childbirth during and after labor by asking women questions about their experiences after birth. The minimum score on the scale is 33, and the maximum score is 198

    Assessment will be conducted before the intervention

  • Fear of Birth- Post intervention

    The Wijma Birth Expectation/Experience Scale was developed to measure the nature of the fear of childbirth during and after labor by asking women questions about their experiences after birth. The minimum score on the scale is 33, and the maximum score is 198

    Assessment will be conducted immediately after the intervention

Study Arms (2)

pilates group

EXPERIMENTAL

Pilates, which lasts for eight weeks, three days a week for 1 hour, will be carried out by Australian Pilates and Physiotherapy Institute certified and experienced Ph.D. Physiotherapist Halil Ibrahim Bulguroglu. The individuals in pilates exercise groups will be divided into six small groups to make the exercises more effective. In this study, the program will be 15 minutes of warm-up, 30 minutes of pilates, and 15 minutes cool-down and stretching exercises. The exercises will be performed in ten repetitions.

Other: pilates group

control group

NO INTERVENTION

The group received breathing and relaxation exercises with a home program.

Interventions

Pilates, which lasts for eight weeks, three days a week for 1 hour, will be carried out by Australian Pilates and Physiotherapy Institute certified and experienced Ph.D. Physiotherapist Halil Ibrahim Bulguroglu. Microsoft Teams program will be used to implement the online practice method. The individuals in both pilates exercise groups will be divided into six small groups of 3 or 4 people to make the exercises more effective. In this study, the program will be 15 minutes of warm-up, 30 minutes of pilates, and 15 minutes of cool-down and stretching exercises. The exercises will be performed in ten repetitions. The same exercises will be applied in online pilates and face-to-face pilates training.

pilates group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Voluntarily participate in research to accept
  • weeks of pregnancy
  • Singleton pregnancy

You may not qualify if:

  • Any cardiovascular, orthopedic, visual, hearing, and perception problems may affect the research results.
  • Participating in other exercises or physiotherapy programs during the past six months.
  • Multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol University

Altındağ, Ankara, 06050, Turkey (Türkiye)

Location

Related Publications (3)

  • Mazzarino M, Kerr D, Morris ME. Pilates program design and health benefits for pregnant women: A practitioners' survey. J Bodyw Mov Ther. 2018 Apr;22(2):411-417. doi: 10.1016/j.jbmt.2017.05.015. Epub 2017 May 31.

    PMID: 29861243BACKGROUND
  • Satyapriya M, Nagendra HR, Nagarathna R, Padmalatha V. Effect of integrated yoga on stress and heart rate variability in pregnant women. Int J Gynaecol Obstet. 2009 Mar;104(3):218-22. doi: 10.1016/j.ijgo.2008.11.013. Epub 2008 Dec 25.

  • Barakat R, Cordero Y, Coteron J, Luaces M, Montejo R. Exercise during pregnancy improves maternal glucose screen at 24-28 weeks: a randomised controlled trial. Br J Sports Med. 2012 Jul;46(9):656-61. doi: 10.1136/bjsports-2011-090009. Epub 2011 Sep 26.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • HALİL İ BULGUROGLU

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants were evaluated at the beginning of the study and 8 weeks later by an experienced physical therapist blind to randomization. The group participants belonged to was not disclosed to the participants from the initial assessment to the end.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Using a computer program, the investigators randomly placed individuals who completed the initial assessment into the pilates group (PG) or control group (CG).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

April 1, 2017

Primary Completion

October 20, 2017

Study Completion

October 30, 2017

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations