Investigation of The Effect of Pelvic Floor Exercise Programme in Elderly.

Not Applicable

Completed

• Conditions: Pelvic Floor Muscle Weakness; Urinary Incontinence in Old Age; Sexual Dysfunction; Quality of Life
• Interventions: Other: Exercise

• Registration Number: NCT04036604
• Lead Sponsor: Akdeniz University

Brief Summary

Alteration of hormonal structure and decreasing of muscle tissue with aging causes pelvic floor dysfunction. Over age of 65 so many factors such as decrease in volume of muscle tissue, decrease in the amount of estrogen / testosterone, and low level of physical activity cause problems such as incontinence, prolapse, constipation and sexual dysfunction The aim of this study is to investigate the effectiveness of pelvic floor exercise program on sexual dysfunction, incontinence, quality of life and physical activity level in elderly.

Detailed Description

Pelvic floor problems including prolapse, voiding and defecation dysfunction have been seen in approximately 37% of women aged 60-79 years and incontinence is the leading pelvic floor dysfunction. The International Incontinence Society (ICS)defines that all types of involuntarily urinary leakage as urinary incontinence. The incidence of urinary incontinence is 26.6% in women aged 65-74 and 41.8% in patients aged 75 and over. Sexual dysfunction is also frequently encountered problem in pelvic floor disorders in people older than 65 years. The aim of this study is to investigate the effectiveness of pelvic floor exercise program on sexual dysfunction, incontinence, quality of life and physical activity level in elderly. Pelvic floor exercises programme contains different contractions of pelvic floor muscle. Each exercises have slow and fast twitch muscle exercise contraction.

Study Timeline

• Study Start: 2019-01-21
• Primary Completion: 2019-05-30
• Study Completion: 2019-06-02
• Status Verified: 2019-07
• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-26
• Last Update Submitted: 2019-07-29
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

To be aged over 65 To attend all exercise class Not to be communication problem

Exclusion Criteria

To have neurogenic bladder To have metastatic prostate or ovary cancer To have enfection in urinary tractus To have pelvic organs malign diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group of pelvic floor exercise	Exercise	Group of pelvic floor exercise include 47 elderly people which contains contraction and repetition of pelvic floor muscle exercises during twice a week for 8 weeks performed by an expert pelvic health physiotherapist.

Primary Outcome Measures

Name	Time	Method
Female Sexual Dysfunction Index	8 weeks	The FSFI is a brief questionnaire measure of sexual functioning in women. It was developed for the specific purpose of assessing domains of sexual functioning (e.g. sexual arousal, orgasm, satisfaction, pain) in clinical trials.
International Index of Erectile Function Questionnaire	8 weeks	The 15-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multi- dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials.
International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)	8 weeks	The ICIQ-UI Short Form is a brief and psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. It is scored on a scale from 0-21.

Secondary Outcome Measures

Name	Time	Method
Physical Activity Scale for the Elderly (PASE)	8 weeks	Physical Activity Scale for the Elderly (PASE) is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiological studies of persons age 65 years and older\[6\].; The PASE score combines information on leisure, household and occupational activity\[7\]. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity. PASE was initially developed in early 90s to provide an instrument to investigate specifically older people with an age-specific physical activity questionnaire, filling what was an important need in epidemiological research at that time
SEAPI-QMM	8 weeks	The SEAPI incontinence questionnaire includes 5 data points that rate severity of specific urinary symptoms. The SEAPI-QMM Incontinence Classification System was developed in the early 1990s as a system that could quantify urinary incontinence and its impact without special equipment or time-consuming procedures.

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Turkey