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Comparison of Aerobics and Pilates Exercises in Primigraivda Females

NCT ID: NCT05811429

Last Updated: 2023-12-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-20

Study Completion Date

2023-08-01

Brief Summary

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Many physical changes, as well as emotional disturbance, occur during pregnancy. In addition to external physical changes, some mental health problems such as depression, sleep and psychosis significantly increase during pregnancy. Aerobic exercises during pregnancy in primigravida females has a positive effect on depression and sleep as a primary and secondary preventive strategy.

The study will be a randomized clinical trial and Setting will be children hospital and Mehmooda hospital sheikhupura. This study will be completed in ten months and convenient sampling technique will be used. Fourty two subjects will be assigned randomly by using lottery method into two groups. Group A will receive Aerobic exercises and Group B will receive Pilate exercises. Warm up (walking) and cool down period of ten minutes will be performed by both groups. Data will be collected from all participants at baseline and after 8 weeks of treatment by using CES-D and PSQI questionnaire. After assessing the data will be analyzed by using parametric or non-parametric test by using SPSS-25.

Detailed Description

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Many physical changes, as well as emotional disturbance, occur during pregnancy. In addition to external physical changes, some mental health problems such as depression, sleep and psychosis significantly increase during pregnancy. Subtle changes experienced by pregnant women can transform their ability to carry out their normal roles and may affect their quality of life, even if the pregnancy is normal. Aerobic exercises during pregnancy in primigravida females has a positive effect on depression and sleep as a primary and secondary preventive strategy. Indeed, exercise has many advantages that may make it a suitable treatment for depression in pregnancy. Pilates is considered a major exercise for improving physical, psychological, and motor functions in pregnancy. This exercise includes a series of low-pressure exercise that build strength and flexibility throughout the body.

The study will be a randomized clinical trial and will be conducted in children hospital sheikhupura and Mehmooda hospital sheikhupura. This study will be completed in time duration of ten months after the approval of synopsis and convenient sampling technique will be used. Total fourty two subjects will be assigned randomly by using lottery method into two groups. Group A will receive Aerobic exercises and Group B will receive Pilate exercises. Warm up (walking) and cool down period of ten minutes will be performed by both groups. Data will be collected from all participants at baseline and after 8 weeks of treatment by using CES-D and PSQI questionnaire. After assessing the data will be analyzed by using parametric or non-parametric test by using SPSS-25.

Conditions

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Depression Sleep Quality Primigravida Females

Keywords

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Aerobic exercises Antenatal depression Pilates exercises Primigravida females Sleep quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Aerobic exercises

Group A will receive aerobic exercises 2 sessions per week for 8 weeks total 16 sessions will be held.

Group Type EXPERIMENTAL

Aerobic exercises

Intervention Type OTHER

16 sessions for 8 weeks ,per week 2 sessions will be given.

Pilates exercises

Group B will receive pilates exercises 2 sessions per week for 8 weeks total 16 sessions will be held.

Group Type ACTIVE_COMPARATOR

Pilates exercises

Intervention Type OTHER

16 sessions for 8 weeks ,per week 2 sessions will be given.

Interventions

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Aerobic exercises

16 sessions for 8 weeks ,per week 2 sessions will be given.

Intervention Type OTHER

Pilates exercises

16 sessions for 8 weeks ,per week 2 sessions will be given.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18-35years
* First pregnancy (primigravida)
* Single pregnancy
* Third trimester (gestational week: 26 weeks to 33 weeks)
* Depressive females (the cut off score on CES-D of 16 will be used to classify women as depressed).

Exclusion Criteria

* Gestational diabetes
* Pregnancy Hypertension
* Placenta previa
* Any previous miscarriage history
* Medically prohibited to do exercise
* Incompetent cervix
* Polyhydramnios, Oligohydramnios
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabiha Arshad, M.Phil

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Children Hospital

Sheikhupura, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 29861243 (View on PubMed)

Eastwood J, Ogbo FA, Hendry A, Noble J, Page A; Early Years Research Group (EYRG). The Impact of Antenatal Depression on Perinatal Outcomes in Australian Women. PLoS One. 2017 Jan 17;12(1):e0169907. doi: 10.1371/journal.pone.0169907. eCollection 2017.

Reference Type BACKGROUND
PMID: 28095461 (View on PubMed)

Mindell JA, Cook RA, Nikolovski J. Sleep patterns and sleep disturbances across pregnancy. Sleep Med. 2015 Apr;16(4):483-8. doi: 10.1016/j.sleep.2014.12.006. Epub 2015 Jan 5.

Reference Type BACKGROUND
PMID: 25666847 (View on PubMed)

Lempersz C, Noben L, van Osta G, Wassen MLH, Meershoek BPJ, Bakker P, Jacquemyn Y, Cuerva MJ, Vullings R, Westerhuis MEMH, Oei GS. Intrapartum non-invasive electrophysiological monitoring: A prospective observational study. Acta Obstet Gynecol Scand. 2020 Oct;99(10):1387-1395. doi: 10.1111/aogs.13873. Epub 2020 May 17.

Reference Type BACKGROUND
PMID: 32306380 (View on PubMed)

Rubio-Arias JA, Marin-Cascales E, Ramos-Campo DJ, Hernandez AV, Perez-Lopez FR. Effect of exercise on sleep quality and insomnia in middle-aged women: A systematic review and meta-analysis of randomized controlled trials. Maturitas. 2017 Jun;100:49-56. doi: 10.1016/j.maturitas.2017.04.003. Epub 2017 Apr 5.

Reference Type BACKGROUND
PMID: 28539176 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/23/0514

Identifier Type: -

Identifier Source: org_study_id