Preventing Pelvic Floor Dysfunction With Pelvic Floor Exercises

NCT ID: NCT06204718

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-09-01

Brief Summary

Study participants will be randomised into 2 groups. Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment

Detailed Description

Voluntary participants who agreed to participate in the study will be randomised into 2 groups of 36 people each (standard pelvic floor exercises and involuntary reflexive pelvic floor exercises) with the "Research Randomizer" programme (https://www.randomizer.org/). Group 1 (36 people) will receive Global Postural Reeducation training plus standard pelvic floor exercises for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face to face, 69 sessions home programme). Even numbers will be included in the 2nd group (36 people) and involuntary reflexive pelvic floor exercises will be given in addition to Global Postural Reeducation training for 12 weeks, 7 days a week (Total 84 sessions, 15 sessions face-to-face, 69 sessions home programme). In the study, detailed pelvic floor training will be given to both groups and the same assessments will be made on the pelvic floor muscles. After the initial assessments are completed, both groups will be given a total of 42 sessions of standard and involuntary reflexive pelvic floor exercises for 6 weeks (7 days a week). Participants in both groups will be evaluated at the end of 6 weeks and the remaining 6 weeks exercise programme will be given according to the arranged programme. At the end of the 12th week, the participants will be evaluated again.

Group 1: 1st assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus standard pelvic floor exercises + 3rd assessment 2nd Group: 1st assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 2nd assessment + 6 weeks of Global Postural Reeducation training plus involuntary reflexive pelvic floor exercises + 3rd assessment

Conditions

Prevention Pelvic Muscle Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard pelvic floor exercises

Standard pelvic floor exercises in addition to Global Postural Reeducation training

Group Type: EXPERIMENTAL

Standard pelvic floor exercises

Intervention Type: OTHER

Pelvic floor muscle exercises will be given as 2 separate exercises including fast and slow contractions. For fast contractions, participants will be asked to contract their pelvic floor muscles strongly, hold them contracted for 5 seconds, and then relax them. For slow contractions, participants will be asked to gradually contract the pelvic floor muscles, hold them at maximum contraction for 5 seconds, and relax them gradually. Participants will be asked to perform 10 slow contractions after every 10 fast contractions. The aim is to train strength, coordination, endurance, and symmetry of pelvic floor muscles, motor learning and control, dynamic lumbopelvic stability, pelvic floor, and abdominal co-contraction. Every day, 10 fast, and 10 slow contractions with a total of 20 repetitions will be applied without changing the number by modifying the exercises every week. It will be applied for a total of 12 weeks.

Involuntary reflexive pelvic floor exercises

Involuntary reflexive pelvic floor exercises in addition to Global Postural re-education training

Group Type: EXPERIMENTAL

Involuntary reflexive pelvic floor exercises

Intervention Type: OTHER

Reflexive exercises (jump, squat jump, etc.) with 20 repetitions per day will be applied to the participants for 12 weeks with modifications every week.

Interventions

Standard pelvic floor exercises

Pelvic floor muscle exercises will be given as 2 separate exercises including fast and slow contractions. For fast contractions, participants will be asked to contract their pelvic floor muscles strongly, hold them contracted for 5 seconds, and then relax them. For slow contractions, participants will be asked to gradually contract the pelvic floor muscles, hold them at maximum contraction for 5 seconds, and relax them gradually. Participants will be asked to perform 10 slow contractions after every 10 fast contractions. The aim is to train strength, coordination, endurance, and symmetry of pelvic floor muscles, motor learning and control, dynamic lumbopelvic stability, pelvic floor, and abdominal co-contraction. Every day, 10 fast, and 10 slow contractions with a total of 20 repetitions will be applied without changing the number by modifying the exercises every week. It will be applied for a total of 12 weeks.

Intervention Type: OTHER

Involuntary reflexive pelvic floor exercises

Reflexive exercises (jump, squat jump, etc.) with 20 repetitions per day will be applied to the participants for 12 weeks with modifications every week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Volunteering to participate in the study
• Being a desk worker between the ages of 18-65
• No pelvic floor dysfunction
• Being a woman

Exclusion Criteria

• Systemic diseases such as hypertension and diabetes mellitus
• Presence of respiratory disease (asthma, COPD, etc...)
• Hormone replacement therapy
• History of neurogenic bladder
• Gynaecological cancer or collagen disease
• Breastfeeding
• Pregnancy
• Early postnatal period (less than one year)
• Pelvic organ prolapse (POP) or gynecological surgery
• Menopause
• Psychiatric comorbidities and/or cognitive impairment
• Impossibility of intra-vaginal physiotherapeutic examination due to untreated active or recurrent urinary infection, haematuria, or vaginal pain during physiotherapy assessment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ebru Kaya Mutlu

UNKNOWN

Sponsor Role: collaborator

Bandırma Onyedi Eylül University

OTHER

Sponsor Role: lead

Responsible Party

Gizem Türkmen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Kaya Mutlu, Professor, PhD

Role: STUDY_DIRECTOR

Bandırma Onyedi Eylül University

Locations

Bandırma Onyedi Eylül University

Bandırma, Balıkesir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023-30

Identifier Type: -

Identifier Source: org_study_id