Clinical trial NCT06331039: The Effects of Pelvic Floor Muscle Training Combined With Otago Exercises in Elderly People With Incontinence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Pelvic Floor Muscle Weakness
Muscle Weakness
Keywords: urinary incontinence
pelvic floor muscle training
elektromyography
balance exercises
Otago Exercises
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi
name: Hacettepe University
name: Dokuz Eylul University
First posted: 2024-03-26
Enrollment: 43
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: incontinence symptoms and severity
timeFrame: baseline and week 12 (after intervention)
measure: balance
timeFrame: baseline and week 14 (after intervention)
measure: bladdery diary
timeFrame: baseline and week 12 (after intervention)
measure: Senior fitness test- functional performance-30-second chair stand test
timeFrame: baseline and week 12 (after intervention)
measure: Senior fitness test- functional performance-Eight (2.45m) Food Up and Go Test
timeFrame: baseline and week 12 (after intervention)
measure: Senior fitness test- functional performance-Chair Sit and Reach Test
timeFrame: baseline and week 12 (after intervention)
measure: Senior fitness test- functional performance-Two Minutes Step Test
timeFrame: baseline and week 12 (after intervention)
measure: Muscle Function- Pelvic floor muscles-Superficial electromyography (EMG)
timeFrame: baseline and week 12 (after intervention).
measure: Fear of falling-Fall Efficacy Scale (FES)
timeFrame: baseline and week 12 (after intervention).
Secondary outcomes:
Other outcomes:
Locations:
city: Mani̇sa
country: Turkey
facility: Melda BAŞER SEÇER
state: Yunusemre
Study officials:
affiliation: Dokuz Eylul University
name: Özge ÇELİKER TOSUN, Assoc. Prof.
role: STUDY_DIRECTOR
References: