Clinical trial NCT05811429: Comparison of Aerobics and Pilates Exercises in Primigraivda Females
Official title: Comparison of Aerobics and Pilates Exercises on Depression and Sleep Quality in Primigravida Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Sleep Quality
Primigravida Females
Keywords: Aerobic exercises
Antenatal depression
Pilates exercises
Primigravida females
Sleep quality
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Center for Epidemiologic Studies Depression Scale (CES-D Scale)
timeFrame: 8 weeks
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sheikhupura
country: Pakistan
facility: Children Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Arshad, M.Phil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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citation: 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.