Investigation of The Effect of Pelvic Floor Exercise Programme in Elderly.
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2019
CompletedFirst Submitted
Initial submission to the registry
July 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedJuly 31, 2019
July 1, 2019
4 months
July 26, 2019
July 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Female Sexual Dysfunction Index
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.
8 weeks
International Index of Erectile Function Questionnaire
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.
8 weeks
International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)
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.
8 weeks
Secondary Outcomes (2)
SEAPI-QMM
8 weeks
Physical Activity Scale for the Elderly (PASE)
8 weeks
Study Arms (2)
Group of pelvic floor exercise
EXPERIMENTALGroup 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.
Group of pelvic floor education
NO INTERVENTIONGroup of pelvic floor education include 47 elderly people which contains anatomy of pelvic floor and dysfunction during once a week for 8 weeks performed by an expert pelvic health physiotherapist.
Interventions
Pelvic floor exercise programme include repetition of pelvic floor muscle contraction during twice a week for 8 weeks performed by an expert pelvic health physiotherapist. Pelvic floor education programme include pelvic floor anatomy, information about pelvic floor dysfunction and behavioral changes.
Eligibility Criteria
You may qualify if:
- To be aged over 65 To attend all exercise class Not to be communication problem
You may not qualify if:
- To have neurogenic bladder To have metastatic prostate or ovary cancer To have enfection in urinary tractus To have pelvic organs malign diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akdeniz University
Antalya, 07070, Turkey (Türkiye)
Related Publications (2)
Engberg S, Sereika SM. Effectiveness of Pelvic Floor Muscle Training for Urinary Incontinence: Comparison Within and Between Nonhomebound and Homebound Older Adults. J Wound Ostomy Continence Nurs. 2016 May-Jun;43(3):291-300. doi: 10.1097/WON.0000000000000227.
PMID: 27163683RESULTSerati M, Braga A, Di Dedda MC, Sorice P, Peano E, Biroli A, Torella M, Cromi A, Uccella S, Salvatore S, Ghezzi F. Benefit of pelvic floor muscle therapy in improving sexual function in women with stress urinary incontinence: a pretest-posttest intervention study. J Sex Marital Ther. 2015;41(3):254-61. doi: 10.1080/0092623X.2014.889052. Epub 2014 Mar 20.
PMID: 24512197RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mehmet Sakıncı, Assos.Prof.
Akdeniz University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assos.Prof.
Study Record Dates
First Submitted
July 26, 2019
First Posted
July 30, 2019
Study Start
January 21, 2019
Primary Completion
May 30, 2019
Study Completion
June 2, 2019
Last Updated
July 31, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share
We have used SPSS for participant data after interventions