- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06271850
Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women
Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
seventy-four breastfeeding women having forward head posture (FHP) will participate in this study. They will be selected randomly from the outpatient clinic of orthopedic of Suez Canal Authority Hospital in Portsaid, Egypt.
Group (A) (Control group): will consist of 37 breastfeeding women. They will receive ergonomic breastfeeding training for 8 weeks.
Group (B) (Study group): will consist of 37 breastfeeding women. They will receive the same ergonomic breastfeeding training plus Pilates exercises 3 times per week for 8 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Port Said, Egypt
- Doaa Onsy Ewass
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All women are breastfeeding and will have FHP.
- They are between six to twelve months post-delivery.
- They should have a single, healthy, and full-term baby without complications.
- Their body mass index (BMI) will not exceed 30 Kg/m2.
- Their parity will range from 2 to 3 children.
- They are housewife.
Exclusion Criteria:
- Cancer of the breast or the surrounding area, any previous breast or chest surgery, breast infection, retracted, cracked, inflamed or inverted nipples.
- Any cardiorespiratory disease, anemia, or diabetes mellitus.
- Recent fracture or surgery of the cervical spine or shoulder.
- History of physical and mental diseases.
Study Plan
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 |
|---|---|
|
Active Comparator: Ergonomic breastfeeding training (control group)
They will receive ergonomics breastfeeding training only.
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The ergonomics training includes the most ergonomically appropriate methods to breastfeed and ergonomic guidelines, including how to cuddle and breastfeed the baby correctly.
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Experimental: Pilates exercises and ergonomic breastfeeding training (study group)
They will receive Pilates exercises, in addition to ergonomics breastfeeding training.
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The ergonomics training includes the most ergonomically appropriate methods to breastfeed and ergonomic guidelines, including how to cuddle and breastfeed the baby correctly.
Pilates exercises, 3 times per week, for 8 weeks, in the form of neck extensor stretching, neck extensor and rotation stretching, pectoral muscle stretching, strengthening of deep neck flexors and scapular retractor, and core strengthening exercises ( pelvic bridging, plank, cat and camel, curl up, single leg abdominal press and double leg abdominal press).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of craniovertebral angle (CVA)
Time Frame: up to 8 weeks
|
It will be measured before and after treatment program by using posture screen analysis mobile application.
This method has many advantages, as it is relatively fast, the image and values obtained are easily preserved, and it is more precise and reliable than visual evaluation alone The CVA is the best indicator of FHP.
To determine this angle, two references are defined: One line that runs from the swallow of the ear to seventh cervical vertebra (C7) and another horizontal line parallel to the ground that passes only through the spinous apophysis of C7.
An angle of less than 50°-53° may indicate FHP.
Thereby, the smaller the CVA, the greater the disability
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up to 8 weeks
|
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Assessment of neck pain intensity
Time Frame: up to 8 weeks
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It will be evaluated before and after treatment program by using VAS, which is a linear scale that measures the magnitude of pain severity.
It encompasses a horizontal line scaled as a spectrum from mild pain beginning from the left to increasing severity to the right end of the horizontal line.
The line is 10 cm in length, with each side of the line ending in extremes either no pain or intense pain.
In terms of utilization, each participant will mark her pain on the line of the spectrum of the scale
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up to 8 weeks
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Measurement of cervical range of motion
Time Frame: up to 8 weeks
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It will be measured before and after treatment program by goniometer.
The movements that will measured by the goniometer include flexion and extension, right and left lateral flexion, and right and left rotation.
The goniometer will be placed on the participant's head.
During all the measurements, the participant will be seated, with her back straight, and looking ahead; her feet will be supported on the floor.
The participant will remain in the same sitting position from the moment the recording procedure will start.
The measurement will be performed from "the neutral" position to the final range of motion in a given plane.
The participant will perform a practice trial.
During each trial, the movement will be executed to reflect the participant's maximum capabilities.
When the maximum movement will be performed in one direction, the final position will be identified and recorded
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up to 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of neck muscle fatigue
Time Frame: up to 8 weeks
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It will be assessed before and after treatment program by the FSS questionnaire, which contains nine statements that rate the severity of fatigue symptoms.
The participant will read each statement and circle a number from 1 to 7, based on how accurately it reflects her condition A low value indicates strong disagreement with the statement, whereas a high value indicates strong agreement.
A total score of less than 36 suggests that participant may not be suffering from fatigue.
A total score of 36 or more suggests that participant may be suffering from fatigue.
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up to 8 weeks
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Assessment of breastfeeding self-efficacy
Time Frame: up to 8 weeks
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It will be measured before and after treatment program by using Breastfeeding Self Efficacy Scale Short Form (BSES-SF), which represents a 14-item self-administered instrument derived from the original 33-item BSES that measures breastfeeding confidence.
All items are preceded by the phrase ''I can always'' and rated on a 5-point Likert scale, ranging from 1 (not at all confident) to 5 (always confident).
Total scores range from 14 to 70, with higher scores reflecting more significant levels of breastfeeding self-efficacy.
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up to 8 weeks
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Measurement of weight and height of baby
Time Frame: up to 8 weeks
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It will be assessed before and after treatment program by using a weighing scale and a length board.
The weighing scale will be calibrated then each baby in both groups will be placed over the scale wearing only the under wears and without the baby diapers two times and the average of the two readings will be taken.
Each baby's length will be measured in a recumbent position using a length board which should be placed on a flat, stable surface such as a table.
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up to 8 weeks
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Evaluation of disability due to neck pain
Time Frame: up to 8 weeks
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It will be evaluated before and after treatment program by the neck disability index, which is a well-validated 10-item questionnaire, with each item rated on a 0 to 5-point scale.
The sum of the 10 items gives a score between 0-50.
The lower the score, the less self-rated the disability.
0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25-34 = severe disability, 35 or over = complete disability
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up to 8 weeks
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Assessment of Health-Related Quality of Life
Time Frame: up to 8 weeks
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It will be assessed before and after treatment program using Free online 36- item short form health survey (SF-36) score calculator.
It measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
its value ranges from 0-100.
0 indicates the worst health state and 100 indicates the best health state.
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up to 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Khadega S Abd El Aziz, PHD, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P.T.REC/012/004949
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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