The Effects of Pelvic Floor Muscle Training Combined With Otago Exercises in Elderly People With Incontinence

Urinary Incontinence Clinical Trial

Official title:

Investigation of the Effects of Pelvic Floor Muscle Training Combined With Otago Exercises on Symptoms, Balance and Functional Status in Elderly People With UI Living in Nursing Homes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06331039
• Other study ID #: CelalBayarU-5
• Status: Completed
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2024
• Source: Celal Bayar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 whether pelvic floor muscle training (PFMT) combined with Otago exercises is effective on symptoms, balance and functional status in elderly people with UI living in nursing homes, compared to PFMT alone.

Description:

The research was conducted on participants over the age of 65 with urinary incontinence living in a nursing home. After these participants were informed about the content of the study, a signed informed consent form will be obtained. This study is an assessor-blinded, randomized controlled trial. Participants with incontinence aged 65 and over living in a nursig home were randomly assigned to intervention (IG) and control group (CG). The intervention group attended an exercise program that included Otago exercises combined with pelvic floor muscle training (PFMT). The control group was included in the PFMT program with different positions. Duration of exercise for both groups was 45-60 minutes per session three times a week for 12 weeks. Incontinence symptoms and severity (Pelvic Floor Distress Inventory-20, bladder diary), PFM muscle function (superficial electromyography), balance (Berg Balance Scale), functional status (Senior Fitness Test) and fear of falling (Falls Efficacy Scale) was measured at baseline and after the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 30, 2023
• Est. primary completion date: August 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenia
• Enuresis
• Muscle Weakness
• Paresis
• Pelvic Floor Muscle Weakness
• Urinary Incontinence

Intervention

Other:
• PFMT
PFM exercises were done. Each session were 45 minutes, 2 days a week on a group basis with the physiotherapist, and 1 day a week as a home program, for 12 weeks.
• PFMT+Otago
It were done by combining Otago exercises and PFM exercises. Each session were 45 minutes, 2 days a week on a group basis with the physiotherapist, and 1 day a week as a home program, for 12 weeks.

Locations

Country	Name	City	State
Turkey	Melda BASER SEÇER	Mani?sa	Yunusemre

Sponsors (4)

Lead Sponsor	Collaborator
Celal Bayar University	Dokuz Eylul University, Hacettepe University, Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incontinence symptoms and severity	SPSS 29 is validated. Pelvic Floor Distress Inventory-20 (PFDI-20) instrument scores were recorded at the baseline and after the intervention. Pelvic Floor Distress Inventory-20 Scale evaluates pelvic organ prolapse, urinary and colorectoanal problems that may develop due to pelvic floor dysfunction, and the degree of complaints about them; It is the short form of the Pelvic Floor Distress Inventory Scale; It consists of 3 subheadings: Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Urinary Distress Inventory-6 (ÜDI-6) and Colorectoanal Distress Inventory-8 (KRADE-8) and a total of 20 questions. Each subheading score ranges from 0-100, and the total score ranges from 0-300. While the best score for each subheading is 0 and the worst score is 100, the best score in total is 0 and the worst score is 300.; Change: Week 12- baseline	baseline and week 12 (after intervention)
Primary	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)
Primary	bladdery diary	SPPS 29 is validated. Bladdery diary were 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 12- baseline	baseline and week 12 (after intervention)
Primary	Senior fitness test- functional performance-30-second chair stand test	SPPS 29 is validated. 30-second chair stand test score were 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 12- baseline.	baseline and week 12 (after intervention)
Primary	Senior fitness test- functional performance-Eight (2.45m) Food Up and Go Test	SPPS 29 is validated.For the test, which is used to evaluate functional mobility and dynamic balance in elderly participants, the participants was seated in a chair with a backrest and armrests, with his back and arms supported. After the command to "get up" was given to the patient, he was asked to walk at his normal speed to an object placed 2.45 m away from the chair, and then turn around the object and walk back. The period started when the patient was commanded to "get up" and was stopped when he/she sat on the chair.; Change: Week 12- baseline.	baseline and week 12 (after intervention)
Primary	Senior fitness test- functional performance-Chair Sit and Reach Test	SPSS 29 is validated.This test, is used especially to determine the flexibility of the hamstring muscle group. The participant was seated on a 43.18 cm high chair leaning against a wall or a solid place, with the junction of the thigh and hip bones in front of the chair. The participant was allowed to extend one foot forward, in full extension, with the heel on the ground and the ankle at approximately 90 degrees, leaving it to the participant's own choice (right or left). The participant was told to stretch his body forward with both hands, without bending his extended knee, and to reach towards his toe without pushing the pain limit. Participant; If the fingertips do not touch the tip of the foot, the distance between them, in centimeters (-), is the participant's; If the fingertips of the middle hand touch the tip of the foot, zero (0) is given to the participant.	baseline and week 12 (after intervention)
Primary	Senior fitness test- functional performance-Two Minutes Step Test	SPPS 29 is validated. In order to perform the test, the participant stands in an upright position; The distance from the front protrusion of the hip bone (iliac crest) to the midpoint of the kneecap (patella) was marked and the midpoint of the distance between these two bones was determined. The participant's step height was determined by marking the height of this determined point from the ground. In order to determine whether the step height reached the target height, a strip was drawn at the determined height or the target height was marked on the wall and it was checked whether the participant's step height (knee height) reached the target height. The participant was made to step where both knees were, reaching the specified height for 2 minutes. At the end of 2 minutes, the total number of right steps taken correctly was recorded.; Change: Week 12-baseline	baseline and week 12 (after intervention)
Primary	Muscle Function- Pelvic floor muscles-Superficial electromyography (EMG)	SPPS 29 is validated.EMG measurement; It was used to record the bioelectrical activity generated by superficial PFM. In the research, NeuroTrac MyoPlus 4 PRO type EMG device was used. Superficial PFM EMG activities were evaluated using disposable, superficial, self-adhesive, silver-silver chloride (Ag/AgCl) electrodes. The diameter of the circular adhesive electrodes was 3.2 cm. The skin area where the superficial electrodes would be attached was cleaned with an alcohol swab to reduce skin impedance. Superficial electrodes were then placed on the muscles parallel to the muscle fibers: superficial PFM- on both sides of the perineal body. The monopolar reference electrode was placed on the right spina iliac anterior superior (SIAS) to eliminate external signals from outside.	baseline and week 12 (after intervention).
Primary	Fear of falling-Fall Efficacy Scale (FES)	SPPS 29 is validated.The first version of the Falls Efficacy Scale (FES) was developed by Tinetti and colleagues in the form of 10 questions covering simple daily living activities to evaluate the fear of falling in the elderly population. It enables the detection and evaluation of the activities that cause fear in people. The Fall Activity Scale-International, which is frequently used today, was developed by Yardley et al.by modifying and preserving the 10 items in the original scale and adding 6 new items. According to this index, as the score increases, the fear of falling increases (scale score between 0-100).; Change: Week 12-baseline	baseline and week 12 (after intervention).