- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04036604
Investigation of The Effect of Pelvic Floor Exercise Programme in Elderly.
Investigation of The Effect of Pelvic Floor Exercise Programme Related to Sexual Dysfunction, Incontinence, Physical Activity Level and Quality of Life in Elderly.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Antalya, Kalkun, 07070
- Akdeniz University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Group of pelvic floor 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.
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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.
Andre navne:
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Ingen indgriben: Group of pelvic floor education
Group 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Female Sexual Dysfunction Index
Tidsramme: 8 weeks
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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.
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8 weeks
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International Index of Erectile Function Questionnaire
Tidsramme: 8 weeks
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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.
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8 weeks
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International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)
Tidsramme: 8 weeks
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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.
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8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
SEAPI-QMM
Tidsramme: 8 weeks
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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.
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8 weeks
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Physical Activity Scale for the Elderly (PASE)
Tidsramme: 8 weeks
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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 |
8 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Mehmet Sakıncı, Assos.Prof., Akdeniz University
Publikationer og nyttige links
Generelle publikationer
- 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.
- Serati 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Adfærdsmæssige symptomer
- Psykiske lidelser
- Patologiske processer
- Sygdomme i nervesystemet
- Urologiske sygdomme
- Nedre urinvejssymptomer
- Urologiske manifestationer
- Neurologiske manifestationer
- Muskuloskeletale sygdomme
- Muskelsygdomme
- Vandladningsforstyrrelser
- Neuromuskulære manifestationer
- Eliminationsforstyrrelser
- Ufrivillig vandladning
- Muskelsvaghed
- Enuresis
Andre undersøgelses-id-numre
- 2012-KAEK-20
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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