Back to resultsPilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life
Primary Purpose
Maternal Fatigue
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pilates excercises, streching and breathing
stretching and breathing
Sponsored by
About this trial
This is an interventional treatment trial for Maternal Fatigue focused on measuring Pilates, maternal fatigue, maternal functioning
Eligibility Criteria
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)
Sites / Locations
- Imrana nasir family clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pilates exercises, streching and breathing
streching and breathing
Arm Description
the intervention Pilates exercises, streching and breathing exercises is administered under supervision
home based exercise program which is streching and breathing.
Outcomes
Primary Outcome Measures
postnatal maternal fatigue
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.
Secondary Outcome Measures
barkin indexmaternal functioning
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.
postnatal quality of life
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.
Full Information
NCT ID
NCT05931588
First Posted
January 4, 2023
Last Updated
June 27, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05931588
Brief Title
Pilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life
Official Title
Effect of Pilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)
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
The aim of the study is to determine the effect of Pilates exercises on postpartum fatigue, maternal functioning and quality of life.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Fatigue
Keywords
Pilates, maternal fatigue, maternal functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilates exercises, streching and breathing
Arm Type
Experimental
Arm Description
the intervention Pilates exercises, streching and breathing exercises is administered under supervision
Arm Title
streching and breathing
Arm Type
Experimental
Arm Description
home based exercise program which is streching and breathing.
Intervention Type
Other
Intervention Name(s)
Pilates excercises, streching and breathing
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
stretching and breathing
Intervention Description
control group guided with stretching and breathing home based program both group till 8 week both groups
Primary Outcome Measure Information:
Title
postnatal maternal fatigue
Description
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.
Time Frame
8 Week
Secondary Outcome Measure Information:
Title
barkin indexmaternal functioning
Description
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.
Time Frame
8 Week
Title
postnatal quality of life
Description
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.
Time Frame
8 Week
Other Pre-specified Outcome Measures:
Title
generalized anxiety scale
Description
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.
Time Frame
8 Week
Title
• Edinburgh postnatal depression scale (EPDS)
Description
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.
Time Frame
8 Week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Summra Andleeb, MS(OMPT)
Organizational Affiliation
riphah internation university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imrana nasir family clinic
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
25000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life
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