Comparison of Aerobics and Pilates Exercises in Primigraivda Females

NCT05811429 | Completed

• 1 other identifier: REC/RCR&AHS/23/0514
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Sleep Quality; Primigravida Females

Keywords

Aerobic exercises; Antenatal depression; Pilates exercises; Primigravida females; Sleep quality

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Aerobic exercises

EXPERIMENTAL

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

Other: Aerobic exercises

Pilates exercises

ACTIVE COMPARATOR

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

Other: Pilates exercises

Interventions

Aerobic exercises OTHER

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

Aerobic exercises

Pilates exercises OTHER

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

Pilates exercises

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Primigravida females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Children Hospital

Sheikhupura, Punjab Province, 39350, Pakistan

Location

Related Publications (5)

• 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: 29861243 BACKGROUND

• 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.

  PMID: 28095461 BACKGROUND

• 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.

  PMID: 25666847 BACKGROUND

• 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.

  PMID: 32306380 BACKGROUND

• 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.

  PMID: 28539176 BACKGROUND

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders

Interventions

Exercise; Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Therapy Modalities; Therapeutics

Study Officials

• Sabiha Arshad, M.Phil

  Riphah International 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: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 13, 2023
• Study Start: November 20, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 1, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)