BreastfeedingNCT06271850
Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women
A study testing Ergonomics breastfeeding training and Pilates exercises in people with Breastfeeding, run by Cairo University at 1 site in Egypt.
Trial summary
Musculoskeletal postural issues stemming from infant care positions can exert a significant impact on the cervical, thoracic, and lumbar spine. These positions can induce mechanical alterations in the spine's natural curvature, potentially resulting in long-term deformities in postnatal women such as forward head… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Ergonomics breastfeeding training and Pilates exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women: A Randomized Controlled Trial
Musculoskeletal postural issues stemming from infant care positions can exert a significant impact on the cervical, thoracic, and lumbar spine. These positions can induce mechanical alterations in the spine's natural curvature, potentially resulting in long-term deformities in postnatal women such as forward head posture (FHP), ultimately contributing to physical disability over the long term.so, The purpose of this study is to determine the effect of Pilates exercises on FHP in breastfeeding women.
Read the 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.
- Conditions
- Breastfeeding
- Being tested
- Ergonomics breastfeeding training, Pilates exercises
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomics breastfeeding trainingOther
The ergonomics training includes the most ergonomically appropriate methods to breastfeed and ergonomic guidelines, including how to cuddle and breastfeed the baby correctly.
Pilates exercisesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Ergonomic breastfeeding training (control group) | Active comparator | They will receive ergonomics breastfeeding training only. Receives: Other: Ergonomics breastfeeding training |
| Pilates exercises and ergonomic breastfeeding training (study group) | Experimental | They will receive Pilates exercises, in addition to ergonomics breastfeeding training. Receives: Other: Ergonomics breastfeeding training; Other: Pilates exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of craniovertebral angle (CVA)
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
Measured: up to 8 weeks
Assessment of neck pain intensity
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
Measured: up to 8 weeks
Measurement of cervical range of motion
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
Measured: up to 8 weeks
Secondary outcomes (5)
Evaluation of disability due to neck pain
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
Measured: up to 8 weeks
Assessment of neck muscle fatigue
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.
Measured: up to 8 weeks
Assessment of breastfeeding self-efficacy
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.
Measured: up to 8 weeks
Measurement of weight and height of baby
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.
Measured: up to 8 weeks
Assessment of Health-Related Quality of Life
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.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start20 Feb 2024
- Primary completion20 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Onsy Ewass, Cairo University
- Investigators
- Khadega S Abd El Aziz, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271850
- Sponsor's protocol ID
- P.T.REC/012/004949
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises on Forward Head Posture in Breastfeeding Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06271850
- Acronym / sponsor ID
- P.T.REC/012/004949
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Musculoskeletal postural issues stemming from infant care positions can exert a significant impact on the cervical, thoracic, and lumbar spine. These positions can induce mechanical alterations in the spine's natural curvature, potentially resulting in long-term deformities in postnatal women such as forward head posture (FHP), ultimately contributing to physical disability over the long term.so, The purpose of this study is to determine the effect of Pilates exercises on FHP in breastfeeding women.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ergonomic breastfeeding training (control group) | Active comparator | Other: Ergonomics breastfeeding trainingThey will receive ergonomics breastfeeding training only. |
| Pilates exercises and ergonomic breastfeeding training (study group) | Experimental | Other: Ergonomics breastfeeding training, Other: Pilates exercisesThey will receive Pilates exercises, in addition to ergonomics breastfeeding training. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ergonomics breastfeeding trainingThe ergonomics training includes the most ergonomically appropriate methods to breastfeed and ergonomic guidelines, including how to cuddle and breastfeed the baby correctly. | Other | Ergonomic breastfeeding training (control group), Pilates exercises and ergonomic breastfeeding training (study group) |
| Pilates exercisesPilates 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). | Other | Pilates exercises and ergonomic breastfeeding training (study group) |
Primary outcome
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
Assessment of neck pain intensity
Time frame: up to 8 weeks
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
Measurement of cervical range of motion
Time frame: up to 8 weeks
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
5 secondary outcomes
Evaluation of disability due to neck pain
Time frame: up to 8 weeks
Assessment of neck muscle fatigue
Time frame: up to 8 weeks
Assessment of breastfeeding self-efficacy
Time frame: up to 8 weeks
Measurement of weight and height of baby
Time frame: up to 8 weeks
Assessment of Health-Related Quality of Life
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khadega S Abd El Aziz, PHD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergonomics breastfeeding training and Pilates exercises in people with Breastfeeding, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of craniovertebral angle (CVA) (time frame: up to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.