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

• Sponsor: Saglik Bilimleri Universitesi (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05410704
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 6.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Telerehabilitation; Body Posture; Pelvic Floor Muscle Training; Diaphragmatic Breathing; Quality of Life	Other: exercises	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Pelvic Floor Muscle Training and Diaphragmatic Breathing Exercise Via Telerehabilitation on Body Posture and Quality of Life Outcomes
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: May 30, 2022
• Anticipated Study Completion Date: May 30, 2022

Arms and Interventions

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.	Other: exercises; 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.

Outcome Measures

Primary Outcome Measures

1. Assessment of Quality of Life [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.

2. Assessment of Body Posture [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.

Secondary Outcome Measures

1. Assessment of Physical Activity Level [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.

2. Assessment of Pelvic Floor Muscle Function [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tülay Ülkü SEVİM	Istanbul		Turkey

Sponsors and Collaborators

• Saglik Bilimleri Universitesi

Investigators

• Study Director: Meltem VURAL, Saglik Bilimleri Universitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Saglik Bilimleri Universitesi
• ClinicalTrials.gov Identifier: NCT05410704
• Other Study ID Numbers: postureandlife
• First Posted: Jun 8, 2022
• Last Update Posted: Jun 8, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Aspiration

Study Results

No Results Posted as of Jun 8, 2022