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Comparison of Aerobics and Pilates Exercises in Primigraivda Females

Primary Purpose

Depression, Sleep Quality, Primigravida Females

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Aerobic exercises
Pilates exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Aerobic exercises, Antenatal depression, Pilates exercises, Primigravida females, Sleep quality

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Children HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic exercises

Pilates exercises

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
March 31, 2023
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05811429
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Sleep Quality, Primigravida Females
Keywords
Aerobic exercises, Antenatal depression, Pilates exercises, Primigravida females, Sleep quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercises
Arm Type
Experimental
Arm Description
Group A will receive aerobic exercises 2 sessions per week for 8 weeks total 16 sessions will be held.
Arm Title
Pilates exercises
Arm Type
Active Comparator
Arm Description
Group B will receive pilates exercises 2 sessions per week for 8 weeks total 16 sessions will be held.
Intervention Type
Other
Intervention Name(s)
Aerobic exercises
Intervention Description
16 sessions for 8 weeks ,per week 2 sessions will be given.
Intervention Type
Other
Intervention Name(s)
Pilates exercises
Intervention Description
16 sessions for 8 weeks ,per week 2 sessions will be given.
Primary Outcome Measure Information:
Title
The Center for Epidemiologic Studies Depression Scale (CES-D Scale)
Description
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
Time Frame
8 weeks
Title
The Pittsburgh Sleep Quality Index (PSQI)
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Primigravida females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabiha Arshad, M.Phil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children Hospital
City
Sheikhupura
State/Province
Punjab
ZIP/Postal Code
39350
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabhia Arshad, M.Phil
Phone
03248495979
Email
s.arshad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Amina batool, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29861243
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.
Results Reference
background
PubMed Identifier
28095461
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.
Results Reference
background
PubMed Identifier
25666847
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.
Results Reference
background
PubMed Identifier
32306380
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.
Results Reference
background
PubMed Identifier
28539176
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.
Results Reference
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Comparison of Aerobics and Pilates Exercises in Primigraivda Females

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