- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05931588
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
32
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Pilates exercises, streching and breathing
the intervention Pilates exercises, streching and breathing exercises is administered under supervision
|
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
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.
|
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
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
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
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
Investigators
- 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)
December 2, 2022
Primary Completion (Actual)
May 5, 2023
Study Completion (Actual)
May 25, 2023
Study Registration Dates
First Submitted
January 4, 2023
First Submitted That Met QC Criteria
June 27, 2023
First Posted (Actual)
July 5, 2023
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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