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Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise on Body Posture

Primary Purpose

Telerehabilitation, Body Posture, Pelvic Floor Muscle Training

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercises
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telerehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tülay Ülkü SEVİMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Study Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 28, 2022
Last Updated
June 5, 2022
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05410704
Brief Title
Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise on Body Posture
Official Title
Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise Via Telerehabilitation on Body Posture and Quality of Life Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation, Body Posture, Pelvic Floor Muscle Training, Diaphragmatic Breathing, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
Pelvic floor muscle exercises and diaphragmatic breathing exercise
Primary Outcome Measure Information:
Title
Assessment of Quality of Life
Description
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.
Time Frame
baseline
Title
Assessment of Body Posture
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Assessment of Physical Activity Level
Description
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.
Time Frame
baseline
Title
Assessment of Pelvic Floor Muscle Function
Description
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.
Time Frame
baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tülay Sevim
Phone
+905349787081
Email
tulayulkusevim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem VURAL
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Director
Facility Information:
Facility Name
Tülay Ülkü SEVİM
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tülay SEVİM
Email
tulayulkusevim@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise on Body Posture

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