Pilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life

June 27, 2023 updated by: Riphah International University

Effect of Pilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life

The aim of the study is to determine the effect of Pilates exercises on postpartum fatigue, maternal functioning and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

the effect of Pilates exercises in reducing postpartum fatigue is not well known however in recent study Pilates exercises alone was quantified which was based on home exercises and had a positive effect, it was conducted in primiparas women, there was also possibility of recall bias due to self report nature of data

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Rawalpindi, Punjab, Pakistan, 25000
        • Imrana nasir family clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Multiparous females
  • Age 18 to 45 years
  • Females with vaginal delivery
  • Two weeks after Spontaneous Vaginal Delivery
  • Fatigue score of >11 on Fatigue Assessment scale

Exclusion Criteria:

  • Postpartum depression score greater or equal to 10 , based on the Edinburgh Postnatal Depression scale (EPDS)
  • Postpartum anemia
  • Generalized Anxiety Disorders
  • Chronic illnesses (Diabetes /hypothyroidism)

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates exercises, streching and breathing
the intervention Pilates exercises, streching and breathing exercises is administered under supervision
Other: Pilates excercises, streching and breathing
international group receive Pilates exercises, stretching and breathing two times a week (30 min per session) perform 3 to 5 reps of Pilates exercises under supervision
Other: stretching and breathing
control group guided with stretching and breathing home based program both group till 8 week both groups
Experimental: streching and breathing
home based exercise program which is streching and breathing.
Other: stretching and breathing
control group guided with stretching and breathing home based program both group till 8 week both groups

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
postnatal maternal fatigue
Time Frame: 8 Week
The Postnatal Accumulated Fatigue Scale (PAFS) (Tsuchiya et al., 2016) was once used to investigate maternal fatigue and included questions masking the three areas of physical, emotional and cognitive fatigue. The PAFS involves thirteen objects with every coded on a three-point response ranking the place zero = rarely, 1 = sometimes and three = often. Total rankings vary from zero to 39 with greater ratings indicating a greater stage of fatigue. The PAFS consists of questions overlaying three areas of physical, emotional, and cognitive fatigue and has top validity and interior consistency.
8 Week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
barkin indexmaternal functioning
Time Frame: 8 Week
The BIMF used to be developed as a multidimensional instrument for measuring maternal functioning in each medical and research settings. It used to be designed in 2010 by way of Barkin et al. This instrument consists of 20 gadgets that cover all factors of maternal functioning, such as self-care, child care, mother-child interaction, household management, psychological well-being, adjustment, and social help.
8 Week
postnatal quality of life
Time Frame: 8 Week
The Maternal Postpartum Quality of Life (MAPP-QOL) instrument consisted of 41 items. The instrument was intended to be completed by mothers during the early postpartum period following hospital discharge. The development of the instrument had two parts (satisfaction and importance) Part 1 queried the participant about her satisfaction with each item (1-6), with 1 = very dissatisfied and 6 =very satisfied. Part 2 queried about her level of importance with each item, 1 = very dissatisfied and 6 = very satisfied. Scores reflect individual values as well as satisfaction, producing a more accurate reflection of QOL.
8 Week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
generalized anxiety scale
Time Frame: 8 Week
The 7-item Generalized Anxiety Disorders Scale (GAD-7; Spitzer) used to be developed as a screener for generalized anxiousness disease (GAD). The seven objects examine (1) feeling nervous, anxious, or on edge; (2) being in a position to quit or manipulate worrying; (3) stressful tool a whole lot about extraordinary things; (4) bother relaxing; (5) being restless; (6) turning into effortlessly aggravated or irritable; and (7) feeling afraid as if something awful may happen.
8 Week
• Edinburgh postnatal depression scale (EPDS)
Time Frame: 8 Week
The EPDS was once delivered in 1987. When at first conceived, this 10-item self-report questionnaire was once designed for use in women in the postnatal period, for the purposes of clinical practice and research.
8 Week

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: summra andleeb, MS(OMPT), riphah internation university

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/01366 Ayesha

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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