Comparison of Aerobics and Pilates Exercises in Primigraivda Females

Depression Clinical Trial

Official title:

Comparison of Aerobics and Pilates Exercises on Depression and Sleep Quality in Primigravida Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05811429
• Other study ID #: REC/RCR&AHS/23/0514
• Status: Completed
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 1, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Sleep Quality

Intervention

Other:
• Aerobic exercises
16 sessions for 8 weeks ,per week 2 sessions will be given.
• Pilates exercises
16 sessions for 8 weeks ,per week 2 sessions will be given.

Locations

Country	Name	City	State
Pakistan	Children Hospital	Sheikhupura	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Center for Epidemiologic Studies Depression Scale (CES-D Scale)	The Center for Epidemiologic Studies Depression Scale (CES-D Scale) was developed for use in studies of the epidemiology of depressive symptomatology in the general population. Its purpose differs from previous depression scales which have been used chiefly for diagnosis at clinical intake and/or evaluation of severity of illness over the course of treatment. The CES-D was designed to measure current level of depressive symptomatology, with emphasis on the affective component, depressed mood. The symptoms are among those on which a diagnosis of clinical depression is based but which may also accompany other diagnoses (including normal) to some degree. The 20-item scale used in the studies reported, possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week	8 weeks
Primary	The Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality. This tool consists of seven areas including: subjective sleep quality, sleep latency, sleep duration, sleep efficiency (the percentage of sleeping time during the time in bed), sleep disturbances (nighttime waking), use of sleeping medications, and daytime dysfunction (distress and impaired daytime functioning). Scoring of answers was based on a scale of 0 to 3 (total score of 21). Higher scores indicate poorer sleep quality. In the present study, all participants received a score of zero for area six (the use of sleeping medications) since we did not allow students who took sleeping medication to participate	8 weeks