NCT05305716

Brief Summary

Studies show that pregnant women reduce their physical activity levels during pregnancy. The pandemic process causes the physical activities of pregnant women to decrease even more and causes a number of problems. This study aims to reveal effect of online Pilates exercises with a physiotherapist during the pandemic conducted on depression, anxiety and fear of childbirth levels of pregnant women. A total of 50 volunteer pregnant women, 26 online pilates group (OPG) and 24 control group (CG), who met the inclusion criteria of the study, were included in our study randomly. The OPG was given online Pilates exercises by the physiotherapist in groups 2 days a week for 8 weeks, 1 h a day. The CG was given a home program consisting of relaxation and breathing exercises. Depression levels; with the Edinburgh Postpartum Depression Scale, anxiety; with the State-Trait Anxiety Inventory, fear of childbirth; with the Wijma Birth Expectation/Experience Scale version B were evaluated before and after the study by using the online questionnaire form filling method. As a result of the online pilates training, there was an improvement in the all test scores (p\<0.05), while no change was observed in the control group (p\>0.05). In the light of these results, 8-week online pilates training applied to gain a healthy habit during the pandemic process and increase physical activity levels of the pregnant women has been concluded to be effective in reducing the levels of depression, anxiety and fear of childbirth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable pregnancy

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

November 3, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

March 22, 2022

Last Update Submit

March 30, 2022

Conditions

Keywords

Pilates exercisesPregnantDepressionAnxiety

Outcome Measures

Primary Outcomes (6)

  • Depression- Baseline

    Edinburgh Postpartum Depression Scale (EPDS) is a self-report scale consisting of 10 items, in a 4-point Likert format. The lowest score that can be obtained from the scale is 0, and the highest score is 30. The cut-off point for EPDS is 13 points. Accordingly, 13 points and above indicate the risk of depression.

    Assessment will be conducted before the intervention

  • Depression-Post intervention

    Edinburgh Postpartum Depression Scale (EPDS) is a self-report scale consisting of 10 items, in a 4-point Likert format. The lowest score that can be obtained from the scale is 0, and the highest score is 30. The cut-off point for EPDS is 13 points. Accordingly, 13 points and above indicate the risk of depression.

    Assessment will be conducted immediately after the intervention

  • Anxiety- Baseline

    State-Trait Anxiety Inventory is a Likert-type scale consisting of 20 questions that measures state and trait anxiety levels separately. There are two kinds of expressions in the scales. These are called direct and reverse expressions. Direct expressions, negative emotions; reversed expressions express positive emotions. The scores obtained from both scales separately vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.

    Assessment will be conducted before the intervention

  • Anxiety-Post intervention

    State-Trait Anxiety Inventory is a Likert-type scale consisting of 20 questions that measures state and trait anxiety levels separately. There are two kinds of expressions in the scales. These are called direct and reverse expressions. Direct expressions, negative emotions; reversed expressions express positive emotions. The scores obtained from both scales separately vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.

    Assessment will be conducted immediately after the intervention

  • Fear of Childbirth- Baseline

    The Wijma Birth Expectation/Experience Scale version B 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, the maximum score is 198.

    Assessment will be conducted before the intervention

  • Fear of Childbirth-Post intervention

    The Wijma Birth Expectation/Experience Scale version B 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, the maximum score is 198

    Assessment will be conducted immediately after the intervention

Study Arms (2)

online pilates group

EXPERIMENTAL

Online pilates training was done for a total of 8 weeks, 2 days a week for 1 hour. Microsoft Teams program was used to perform the exercises online. The investigators divided the individuals in the online pilates exercise group into seven smaller groups of 3 or 4 to verify whether they correctly did the exercises. A program including 15 minutes of warm-up, 30 minutes of Pilates exercises and 15 minutes of cooling and stretching exercises was arranged for the online pilates group and the exercises were performed as 10 repetitions. The exercise program recommended by the Australian Pilates and Physiotherapy Institute during pregnancy was used in the online training.

Other: Online Pilates Training

control group

ACTIVE COMPARATOR

The control group was given breathing and relaxation exercises, which they would do two days a week for eight weeks, in the form of a home program. Diaphragmatic breathing and respiratory control were given as breathing exercises.

Other: Control group

Interventions

The group that received telerehabilitation and telerehabilitation-based pilates training.

online pilates group

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

control 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 that may affect the results of the research.
  • Participating in other exercises or physiotherapy programs during the past 6 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 (6)

  • Arundell L, Salmon J, Timperio A, Sahlqvist S, Uddin R, Veitch J, Ridgers ND, Brown H, Parker K. Physical activity and active recreation before and during COVID-19: The Our Life at Home study. J Sci Med Sport. 2022 Mar;25(3):235-241. doi: 10.1016/j.jsams.2021.10.004. Epub 2021 Oct 14.

    PMID: 34742627BACKGROUND
  • Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

    PMID: 3651732BACKGROUND
  • Bunevicius A, Kusminskas L, Pop VJ, Pedersen CA, Bunevicius R. Screening for antenatal depression with the Edinburgh Depression Scale. J Psychosom Obstet Gynaecol. 2009 Dec;30(4):238-43. doi: 10.3109/01674820903230708.

    PMID: 19845492BACKGROUND
  • Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.

    PMID: 9638601BACKGROUND
  • Suner-Keklik S, Numanoglu-Akbas A, Cobanoglu G, Kafa N, Guzel NA. An online pilates exercise program is effective on proprioception and core muscle endurance in a randomized controlled trial. Ir J Med Sci. 2022 Oct;191(5):2133-2139. doi: 10.1007/s11845-021-02840-8. Epub 2021 Oct 30.

  • Bulguroglu M, Bulguroglu HI. The effects of online pilates on the mood and fear of birth of pregnant women: a randomized controlled study. Sci Rep. 2024 Jul 12;14(1):16143. doi: 10.1038/s41598-024-67290-5.

MeSH Terms

Conditions

COVID-19DepressionAnxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • HALIL IB BULGUROGLU, PHD PT

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

November 3, 2021

Primary Completion

March 10, 2022

Study Completion

March 15, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations