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

NCT ID: NCT06331039

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2023-09-30

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.

Conditions

Urinary Incontinence; Pelvic Floor Muscle Weakness; Muscle Weakness

Study Design

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

Study Groups

PFMT+Balance Group

PFMT+Otago group was included in the program that includes Otago exercises and pelvic floor muscle training. Otago 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. Otago exercises consist of strengthening, balance exercises and walking program. Warm-up exercises were performed before each program and cooling exercises were performed at the end of the program. Exercises were performed for 45-60 minutes in each session.

Group Type: EXPERIMENTAL

PFMT+Otago

Intervention Type: OTHER

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.

PFMT Group

PFMT group was 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.

Group Type: EXPERIMENTAL

PFMT

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: collaborator

Dokuz Eylul University

OTHER

Sponsor Role: collaborator

Celal Bayar University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Özge ÇELİKER TOSUN, Assoc. Prof.

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Melda BAŞER SEÇER

Manisa, Yunusemre, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Baser Secer M, Celiker Tosun O, Akbayrak T, Ilcin N, Tosun G. Does combining two evidence-based exercise programs in elderly people with incontinence have a triple effect on incontinence symptoms, balance and functional status? Int Urol Nephrol. 2025 Jan;57(1):79-91. doi: 10.1007/s11255-024-04177-4. Epub 2024 Aug 1.

Reference Type: DERIVED

PMID: 39090517 (View on PubMed)

Other Identifiers

CelalBayarU-5

Identifier Type: -

Identifier Source: org_study_id