Comparison of Aerobics and Pilates Exercises in Primigraivda Females

December 26, 2023 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sheikhupura, Punjab, Pakistan, 39350
        • Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic exercises
Group A will receive aerobic exercises 2 sessions per week for 8 weeks total 16 sessions will be held.
Other: Aerobic exercises
16 sessions for 8 weeks ,per week 2 sessions will be given.
Active Comparator: Pilates exercises
Group B will receive pilates exercises 2 sessions per week for 8 weeks total 16 sessions will be held.
Other: Pilates exercises
16 sessions for 8 weeks ,per week 2 sessions will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Center for Epidemiologic Studies Depression Scale (CES-D Scale)
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sabiha Arshad, M.phil, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2022

Primary Completion (Actual)

July 30, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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