- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05410704
Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise on Body Posture
June 5, 2022 updated by: Saglik Bilimleri Universitesi
Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise Via Telerehabilitation on Body Posture and Quality of Life Outcomes
This study; It will be done in order to show evidence of the effects of pelvic floor muscle training and diaphragmatic breathing exercise via telerehabilitation on body posture and quality of life in healthy individuals.
International Physical Activity Quastionnaire Short Form (IPAQ), Pelvic Floor Impact Quastionnaire Short Form (PFIQ-7), 36-Item Short Form Survey(SF-36) and New York Posture Rating Chart will be applied.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
36
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 Contact
- Name: Tülay Sevim
- Phone Number: +905349787081
- Email: tulayulkusevim@gmail.com
Study Locations
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-
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Istanbul, Turkey
- Recruiting
- Tülay Ülkü SEVİM
-
Contact:
- Tülay SEVİM
- Email: tulayulkusevim@gmail.com
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Body Mass Index between 18-25
- Being a woman over the age of 18
Exclusion Criteria:
- obstructive or restrictive lung disease
- diagnosed with urinary incontinence or pelvic organ prolapse
- pelvic pain
- history of pelvic surgery
- Any history of spinal, thoracic or abdominal surgery
- To smoke
- cardiac, neurological and rheumatological disease
- Congenital deformity or previous history of surgery in the spine and thorax
- endocrine and metabolic disease
- psychiatric disorders
- cardiological disorders
- malignancy
- Doing regular physical activity or sports for the last 3 months
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Pelvic floor muscle exercises and diaphragmatic breathing exercises will be performed 3 times a week for 12 weeks.
New York Posture Rating Scale and SF-36 will be applied before and after the study.
International Physical Activity Questionnaire and Pelvic Floor Impact Questionnaire will be applied before the study.
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Pelvic floor muscle exercises and diaphragmatic breathing exercise
|
|
No Intervention: Control Group
No intervention.
New York Posture Rating Scale and SF-36 will be applied before and after the study.
International Physical Activity Questionnaire and Pelvic Floor Impact Questionnaire will be applied before the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Quality of Life
Time Frame: baseline
|
36-Item Short Form Survey (SF-36).
On the scale, higher scores mean a better outcome.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
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baseline
|
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Assessment of Body Posture
Time Frame: baseline
|
New York Posture Rating Chart.
On the scale, each body segment was scored 5 (correct posture), 3 (slight deviation), or 1 (pronounced deviation).
The scores of the body alignment segments are summed, allowing a range of overall score between 13 and 65.
Higher scores mean a better outcome.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Physical Activity Level
Time Frame: baseline
|
International Physical Activity Questionnaire-short form (IPAQ-SF) The questionnaire records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.
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baseline
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Assessment of Pelvic Floor Muscle Function
Time Frame: baseline
|
Pelvic Floor Impact Questionnaire (PFIQ).
The PFIQ 7 has 7 questions and each question has 3 separate responses.
The response to each item of satisfaction, impact and worry was rated from 3 (quite a bit) to 0 (not at all) for the PFIQ-7.
The mean value for all the answered items within the corresponding scale (possible value 0-3) was estimated, then multiplied by (100/3) to obtain the scale score, range 0-100.
We added the scores from the 3 scales together to obtain the PFIQ 7 summary score (range 0-300).For the scale, a higher score indicates worse health status.
|
baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Meltem VURAL, Saglik Bilimleri Universitesi
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 1, 2021
Primary Completion (Anticipated)
May 30, 2022
Study Completion (Anticipated)
May 30, 2022
Study Registration Dates
First Submitted
May 28, 2022
First Submitted That Met QC Criteria
June 5, 2022
First Posted (Actual)
June 8, 2022
Study Record Updates
Last Update Posted (Actual)
June 8, 2022
Last Update Submitted That Met QC Criteria
June 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- postureandlife
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.