Clinical trial NCT06547580: Effects of Group-based and Individual Pelvic Floor Muscle Training on Elderly Individuals With Urinary Incontinence
Official title: Examining the Effects of Group-based and Individual Pelvic Floor Muscle Training on Elderly Individuals With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
pelvic floor muscle training
elderly people
elektromyography
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 35
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: The purpose of this study is to asses the effects of 12-week group-based and individually planned pelvic floor muscle training on individuals aged 65 and over with urinary incontinence.

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 individualized pelvic floor muscle with Emg biofeedback training (individualized-PFMT). The control group was included in the group-based PFMT program. 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 and abdominal muscle function (superficial electromyography), balance (Berg Balance Scale), functional status (Senior Fitness Test), hand grip strength, knee extansor, ankle dorsi-plantar flexion muscle srength, sleep quality and fear of falling (Falls Efficacy Scale) was measured at baseline and after the intervention.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Having severe walking and balance problems
* Severe cognitive impairment (Mini mental state assessment test score below
* Having a serious neurological problem
* Having serious heart diseases
* Having a genito-urinary infection
* Having pelvic organ prolapse
* Six months ago he received medication for incontinence
* Having had incontinence and abdominal surgery
* Having metastatic cancer
* Having any vision problems

Primary outcomes:
measure: incontinence symptoms and severity
timeFrame: baseline and week 12 (after intervention)
measure: balance
timeFrame: baseline and week 12 (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: Muscle Function- Abdominal 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)
measure: hand grip strength
timeFrame: baseline and week 12 (after intervention)
measure: Knee extensor muscle strength
timeFrame: baseline and week 12 (after intervention)
measure: Ankle dorsi-plantar flexion muscle strength
timeFrame: baseline and week 12 (after intervention)
measure: sleep quality (Pitsburg Sleep Quality Index-PSQI)
timeFrame: baseline and week 12 (after intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Mani̇sa
country: Turkey
facility: Melda BAŞER SEÇER
state: Yunusemre
city: Mani̇sa
country: Turkey
facility: Melda BAŞER SEÇER
state: Yunusemre
Study officials:
affiliation: Dokuz Eylul University
name: Özge ÇELİKER TOSUN
role: STUDY_DIRECTOR
References: