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NCT Number: NCT05811429

Comparison of Aerobics and Pilates Exercises in Primigraivda 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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Dyssomnias Mental Disorders Nervous System Diseases Primigravida Females Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children Hospital

Sheikhupura, Punjab Province, 39350, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aerobic exercises

Other

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

Pilates exercises

Other

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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