TelerehabilitationNCT05410704
Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise on Body Posture
A study testing exercises in people with Telerehabilitation and Body Posture, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Telerehabilitation, Body Posture, Pelvic Floor Muscle Training
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 30 May 2022
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index between 18-25
- Being a woman over the age of 18
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tülay Ülkü SEVİM
Istanbul
Tülay SEVİM, tulayulkusevim@gmail.com
About this study
Official title: 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.
- Conditions
- Telerehabilitation, Body Posture, Pelvic Floor Muscle Training, Diaphragmatic Breathing, Quality of Life
- Being tested
- exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
Pelvic floor muscle exercises and diaphragmatic breathing exercise
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | 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. Receives: Other: exercises |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Quality of Life
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.
Measured: baseline
Assessment of Body Posture
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.
Measured: baseline
Secondary outcomes (2)
Assessment of Physical Activity Level
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.
Measured: baseline
Assessment of Pelvic Floor Muscle Function
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Dec 2021
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meltem VURAL, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410704
- Sponsor's protocol ID
- postureandlife
- Status last verified
- May 2022
- First submitted
- 28 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise Via Telerehabilitation on Body Posture and Quality of Life Outcomes
- ClinicalTrials.gov ID
- NCT05410704
- Acronym / sponsor ID
- postureandlife
- Conditions
- Telerehabilitation, Body Posture, Pelvic Floor Muscle Training, Diaphragmatic Breathing, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 8 Jun 2022 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: exercisesPelvic 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index between 18-25
- Being a woman over the age of 18
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| exercisesPelvic floor muscle exercises and diaphragmatic breathing exercise | Other | Study Group |
Primary outcome
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.
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.
2 secondary outcomes
Assessment of Physical Activity Level
Time frame: baseline
Assessment of Pelvic Floor Muscle Function
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Meltem VURAL study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with Telerehabilitation and Body Posture, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 8 Jun 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tülay Sevim (+905349787081, tulayulkusevim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Quality of Life (time frame: baseline). The study lists 2 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 8 Jun 2022.