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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06331039
• Other study ID #: CelalBayarU-5
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: Celal Bayar University
• Contact: Melda Baser Seçer, Phd
• Phone: +905547285453
• Email: melda.secer[@]cbu.edu.tr
• 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: July 30, 2024
• Est. primary completion date: April 5, 2024
• 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
• Muscle Weakness
• Paresis
• Pelvic Floor Muscle Weakness
• Urinary Incontinence

Intervention

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.
• 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.

Locations

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

Sponsors (3)

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

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
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 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)
Primary	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)