The Effects of Pelvic Floor Muscle Training and Balance Exercises in Elderly People With Incontinence

Investigation of the Effects of Pelvic Floor Muscle Training and Balance Exercises on Ankle Muscle Function, Joint Range of Motion and Balance in Elderly People With Incontinence

Pelvic floor muscle weakness is one of the most important causes of incontinence. There are many studies supporting that pelvic floor muscle training prevents incontinence and reduces symptom severity, and with A level of evidence, it is among the first in the conservative treatment of incontinence. Functional status and balance problems are common in elderly people with incontinence, and it is known that functional type incontinence is common. Elderly people with incontinence most often fall while trying to get to the toilet. Balance exercises are recommended for falls and balance problems.

The aim of this study is to examine the effects of pelvic floor muscle training and balance exercises on ankle muscle function, joint range of motion and balance in individuals aged 65 and over with urinary incontinence.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence; Muscle Weakness; Pelvic Floor Muscle Weakness
• Intervention / Treatment: Other: PFMT+Balance; Other: PFMT

Detailed Description

The research will be conducted on participants over the age of 65 with urinary incontinence living in a nursing home. After these participants are informed about the content of the study, a signed informed consent form will be obtained. Participants who meet eligibility requirements will be randomized in a single-blind manner (participant) into 2 groups: intervention and control groups. Both groups will be informed about balance exercises, fall risk factors, pelvic anatomy, pelvic floor muscles, and bladder training before the first session. In the evaluations made for both groups in the study, before the intervention and after the 14-week intervention; Superficial electromyography (EMG) for pelvic floor and ankle dorsi and platear flexor muscle function, digital goniometer for ankle joint range of motion measurement, digital manual muscle strength measurement device for ankle dorsi and plantar flexors muscle strength measurement, data recording for demographic information Form, Pelvic Floor Distress Inventory (PTDE-20) will be used to determine urinary incontinence symptoms and severity, "30-second sit-stand test" and Berg Balance Scale (BBS) will be used for balance.

The exercise program, which includes pelvic floor muscle training and balance exercises, will be applied to the intervention group on a group basis for 14 weeks, twice a week, accompanied by a physiotherapist, as a home program in 1 day; and the pelvic floor muscle training will be applied to the control group on a group basis for 14 weeks, twice a week, accompanied by a physiotherapist, as a home program in 1 day. Evaluations will be made before the intervention and after 14 weeks of intervention.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melda BAŞER SEÇER, PhD; Phone Number: +905547285453; Email: melda.secer@cbu.edu.tr
• Study Contact Backup: Name: Özge ÇELİKER TOSUN, Assoc. Prof; Phone Number: +905055252029; Email: ozge.tosun@deu.edu.tr

Study Locations

• Turkey
  • Yunusemre
    • Mani̇sa, Yunusemre, Turkey, 45000
      • Melda BAŞER SEÇER
      • Contact: Melda BAŞER SEÇER, PhD; Phone Number: +905547285453; Email: melda.secer@cbu.edu.tr
      • Contact: Özge ÇELİKER TOSUN, Assos. Prof.; Phone Number: +905055252029; Email: ozge.tosun@deu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Having signed the informed volunteer consent form
2. Being 65 years or older
3. Having urinary incontinence
4. Ability to walk unaided and not use any walking aids

Exclusion Criteria:

1. Having severe walking and balance problems
2. Severe cognitive impairment (Mini mental state assessment test score below 23)
3. Having a serious neurological problem
4. Having serious heart diseases
5. Having a genito-urinary infection
6. Having pelvic organ prolapse
7. Six months ago he received medication for incontinence
8. Having had incontinence and abdominal surgery
9. Having metastatic cancer
10. Having any vision problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PFMT+Balance Group; PFMT+Balance group will be included in the program that includes balance exercises and pelvic floor muscle training. Balance exercises combined with pelvic floor muscle training will be performed 3 days a week (with a 1-day rest gap between 2 sessions) for 45 minutes per day. Balance exercises will include 12 different exercises (squatting, walking backwards, turning around, walking sideways, tandem stance, tandem walking, standing on one leg, walking on the heel, walking on the toes, walking backwards, sitting down, going down stairs). starting from a supported position and progressing to exercises performed without support.	Other: PFMT+Balance; It will be done by combining balance exercises and PFM exercises. Each session will be 45 minutes, 2 days a week on a group basis with the physiotherapist, and 1 day a week as a home program, for 14 weeks.
Experimental: PFMT Group; PFMT group will be included in a program that includes pelvic floor muscle training, 3 days a week (with 1 day of rest between 2 sessions) and 45 minutes per day.	Other: PFMT; PFM exercises will be done. Each session will be 45 minutes, 2 days a week on a group basis with the physiotherapist, and 1 day a week as a home program, for 14 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ankle muscle function	SPSS 29 is validated. Using superficial electromyography for ankle muscle function, the initial and post-treatment values of the gastrocinemus and tibialis anterior muscles will be recorded. Change: Week 14-baseline	baseline and week 14 (after intervention)
ankle range of motion	SPSS 29 is validated. Ankle range of motion will be measured and recorded with a digital goniometer at baseline and after the intervention. Change: Week 14-baseline. Ankle range of motion will be measured and recorded with a digital goniometer at baseline and after the intervention. Tibialis anterior and gastrocinemus muscle strength will be recorded by measuring baseline and after intervention using a manual muscle tester. Change: Week 14-baseline	baseline and week 14 (after intervention)
muscle strength	SPSS 29 is validated. Tibialis anterior and gastrocinemus muscle strength will be recorded by measuring baseline and after intervention using a manual muscle tester. Change: Week 14-baseline.	baseline and week 14 (after intervention)
balance	SPPS 29 is validated. Berg Balance Scale score will be recorded at baseline and after the intervention. It consists of fourteen items. The proficiency level in the activity for each item is 0; "cannot", 4; It is indicated with 5 points (0-4), "makes it independent and safe". The 14 functional parameters included in Berg Balance Scale. The maximum score that participants can get from the test is 56 and reflects an excellent balance function. (0-20 points; severe fall risk, 21-40 points; moderate fall risk, 41-56; mild fall risk). The fall risk limit for this test is 45 points. Change: Week 14- baseline	baseline and week 14 (after intervention)
bladdery diary	SPPS 29 is validated. Bladdery diary will be recorded at the baseline and after the intervention. The patient records the type and amount of fluid he/she takes, the frequency of urinary incontinence, the urination volume, the frequency of urination at night, and the situations in which he/she leaks urine, along with the times in a 24-hour voiding diary. It is an objective evaluation method used to determine the type and degree of incontinence. Change: Week 14- baseline	baseline and week 14 (after intervention)
functional performance	SPPS 29 is validated. 30-second chair stand test score will be recorded at the baseline and after the intervention. The participant was asked to sit in the middle part of a 43.18 cm (12in) high chair with his back upright, feet on the ground and arms crossed in front of his chest (right hand on the left shoulder, left hand on the right shoulder). While in this position, the participant starts the test with the start command and takes off as fully as he can during 30 seconds. The number of complete takes off during 30 seconds determines the score.A score of less than 10 in 30 seconds indicates lower extremity muscle weakness. Change: Week 14- baseline.	baseline and week 14 (after intervention)
incontinence symptoms and severity	SPSS 29 is validated. Urogenital Distress Inventory (UDI-6) instrument scores will be recorded at the baseline and after the intervention. Urogenital Distress Inventory consists of 6 questions. It includes three subscales: irritative symptoms (urgency, frequency, pain), stress symptoms, and obstructive/disturbing or urination difficulty symptoms.The scoring options for each item are 0: not at all, 1: slightly, 2: moderate, and 3: very much. Minimum 0 - maximum 18 points from UDI-6.Increasing scores from the scales indicate that the quality of life level is deteriorating. Change: Week 14- baseline	baseline and week 14 (after intervention)
incontinence symptoms and severity	PSS 29 is validated. Incontinence Impact Questionnaire (IIQ-7) instrument scores will be recorded at the baseline and after the intervention. The Incontinence Impact Questionnaire consists of 7 questions. It includes four sub-dimensions: physical activity, travel, social relations and emotional health.The scoring options for each item are 0: not at all, 1: slightly, 2: moderate, and 3: very much. Minimum 0 - maximum 21 points from IIQ-7.Increasing scores from the scales indicate that the quality of life level is deteriorating. Change: Week 14- baseline	baseline and week 14 (after intervention)

Collaborators and Investigators

• Sponsor: Celal Bayar University
• Collaborators: Saglik Bilimleri Universitesi; Dokuz Eylul University
• Investigators: Study Director: Özge ÇELİKER TOSUN, Assoc. Prof., Dokuz Eylül University

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2024
• Primary Completion (Estimated): April 5, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pelvic floor muscle training; balance exercises; ürinary incontinece; elektromyography
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Urination Disorders; Neuromuscular Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Muscle Weakness; Paresis; Asthenia
• Other Study ID Numbers: CelalBayarU-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data is saved on my hard disk, I can share it if desired.
• IPD Sharing Time Frame: five year
• IPD Sharing Access Criteria: If it is necessary
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No