- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06581601
Sjukgymnastikhantering hos kvinnor med urininkontinens
Sjukgymnastikhantering hos kvinnor med urininkontinens med hänsyn till postural stabilitet, posturalt mönster, bäckentyp, livskvalitet och sexuell aspekt
Main objective:
The primary aim of the study is to assess whether the author's exercise programme has an effect on reducing urinary incontinence and pelvic floor dysfunction after childbirth, considering vacuum extractor, forceps and caesarean section deliveries.
Secondary objective:
The secondary objective is to determine whether the duration of the author's exercise programme is sufficient to achieve positive changes in women.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The study will involve women with stress urinary incontinence, urge urinary incontinence, and mixed urinary incontinence. Participants will be women aged 20-80 years (meeting inclusion criteria: urinary incontinence, regular menstrual cycles, pre-and post menopausal period, natural childbirth or cesarean section, and deliveries using forceps and vacuum extractors; exclusion criteria: no urinary incontinence, irregular menstrual cycles, no childbirth, abdominal surgeries/procedures, active cancer, no gynecological check-up in the last 12 months, recurrent urogenital infections, joint hypermobility). A total of 300 women will be examined, including 100 women meeting the inclusion criteria, 100 women meeting the inclusion criteria but not interested in exercising, and 100 healthy women. Participants can withdraw from the study at any stage.Study Group Division
Based on the evaluation of posture type, pelvic pattern, and postural stability, participants will be divided into three groups:
- Women meeting inclusion criteria performing the author's exercise program - experimental group.
- Women meeting inclusion criteria but not interested in performing the author's exercise program - control group.
- Healthy women - control group. The experimental group will perform the author's pelvic floor muscle exercise program daily for six weeks, at a fixed time each day, under weekly physiotherapist supervision and independently on other days (after proper instruction by the physiotherapist).
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Małgorzata Wójck, PhD PT
- Telefonnummer: 121 +489572 79 100
- E-post: m.wojcik@awf-gorzow.edu.pl
Studieorter
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Poznan, Polen, 61-871
- Rekrytering
- 1Department of Physiotherapy, Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wlkp., 61-871 Poznan
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Kontakt:
- Małgorzata Wójcik, PhD
- E-post: m.wojcik@awf-gorzow.edu.pl
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Urinary incontinence
- Regular menstrual cycles
- Pre and post-menopausal period
- Natural childbirth or cesarean section
- Deliveries using forceps and vacuum extractors
Exclusion Criteria:
- No urinary incontinence
- Irregular menstrual cycles
- No childbirth
- Abdominal surgeries/procedures Active cancer No gynecological check-up in the last 12 months Recurrent urogenital infections Joint hypermobility
Contorl group will be healthy women
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Control group
1.Contorl group: healtyhy women. |
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Experimentell: Pre-menopausal group
2.Pre-menopasal group: experimental group - exercise's group |
An author's questionnaire will be used for participant selection, asking about the number and course of deliveries. Additionally, participants will log daily activities to calculate the physical activity level coefficient. Weight and height will be measured using a Tanita device to calculate BMI. The posture type and pelvic type will be assessed. Participants will be asked to complete the following questionnaires before and after the intervention: Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire Short Form (PFIQ-7 SF), Sexual Satisfaction Scale (SSS-W-R15), Neck Disability Pain Index, Revised Oswestry Low Back Pain Disability Scale, Migraine Disability Assessment (MIDAS), Hospital Anxiety and Depression Scale (HADS), Short Form McGill Pain Questionnaire, CRANIA (Integrated Approach to Cranio Mandibular Neuroscience) questionnaire, IPAQ (International Physical Activity Questionnaire). Modified 1-Hour Pad Test. Execution of the Author's Training Program.
Andra namn:
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Experimentell: Post-menopausal group
3.Post-menopausal group: experimental group - exercise's group |
An author's questionnaire will be used for participant selection, asking about the number and course of deliveries. Additionally, participants will log daily activities to calculate the physical activity level coefficient. Weight and height will be measured using a Tanita device to calculate BMI. The posture type and pelvic type will be assessed. Participants will be asked to complete the following questionnaires before and after the intervention: Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire Short Form (PFIQ-7 SF), Sexual Satisfaction Scale (SSS-W-R15), Neck Disability Pain Index, Revised Oswestry Low Back Pain Disability Scale, Migraine Disability Assessment (MIDAS), Hospital Anxiety and Depression Scale (HADS), Short Form McGill Pain Questionnaire, CRANIA (Integrated Approach to Cranio Mandibular Neuroscience) questionnaire, IPAQ (International Physical Activity Questionnaire). Modified 1-Hour Pad Test. Execution of the Author's Training Program.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Modified 1-Hour Pad Test, measurement in grams
Tidsram: before start exercises and after six week finish exercises
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Before starting the author's six-week exercise program and after its completion, a modified 1-hour PAD Test will be conducted, which involves checking the amount of urine lost, during strictly defined activities. The test follows the guidelines in the literature. The test subject puts on a pre-weighed pad and, after emptying the bladder, drinks 500ml of water over 15 minutes. The test subject then waits 30 minutes. After this time, the test begins with 15 minutes of walking and climbing stairs. The test subject then performs a special training program: 10 times she stands up and sits down on a chair, 10 times she coughs vigorously, 10 times she picks up a bottle of water from the ground, runs in place for 1 minute, and for 1 minute he holds his hands under running water. After the test is completed, the pad is weighed again and the amount of urine lost during the test is assessed. |
before start exercises and after six week finish exercises
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Floor Disability Index
Tidsram: before start exercises and after six week finish exercises
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Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score. |
before start exercises and after six week finish exercises
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Pelvic Floor Impact Questionnaire Short Form
Tidsram: before start exercises and after six week finish exercises
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Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score. |
before start exercises and after six week finish exercises
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Sexual Satisfaction Scale
Tidsram: before start exercises and after six week finish exercises
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Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score. |
before start exercises and after six week finish exercises
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Neck Disability Pain Index
Tidsram: before start exercises and after six week finish exercises
|
Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score. |
before start exercises and after six week finish exercises
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Revised Oswestry Low Back Pain Disability Scale
Tidsram: before start exercises and after six week finish exercises
|
Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score. |
before start exercises and after six week finish exercises
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Migraine Disability Assessment
Tidsram: before start exercises and after six week finish exercises
|
Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score. |
before start exercises and after six week finish exercises
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Hospital Anxiety and Depression Scale
Tidsram: before start exercises and after six week finish exercises
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Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score. |
before start exercises and after six week finish exercises
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Short Form McGill Pain Questionnaire
Tidsram: before start exercises and after six week finish exercises
|
Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score. |
before start exercises and after six week finish exercises
|
|
CRANIA (Integrated Approach to Cranio Mandibular Neuroscience) questionnaire
Tidsram: before start exercises and after six week finish exercises
|
Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The lower the value of the points received, the better the score. |
before start exercises and after six week finish exercises
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International Physical Activity Questionnaire
Tidsram: before start exercises and after six week finish exercises
|
Before the exercise begins and after it is completed, i.e. after 6 weeks, participants will fill out anonymously standardized questionnaires, in which they will have to mark the answer with an assigned score. The results will then be counted and scores will be assigned according to a key. The higher the value of the points received, the better the score. |
before start exercises and after six week finish exercises
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Posture type Assessment by Hall-Wernham-Littlejohn, The result based on the observation of the posture with the use of the vertical, there is no measure or unit here.
Tidsram: before start exercises
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Type I correct: The examinee stands sideways, the plumb line is applied to the mastoid process of the temporal bone, correctly the plumb line runs along the cervical segment, through the middle of the shoulder, knee joint. For the front type II, the measurement is taken as before but the head is extended forward, the vertical course.Anterior pelvic tilt is still observed. With the rear type III, measurement as before. The vertical does not go through the center of the shoulder and knee. A posterior tilt of the pelvis, a rounded back and a receding head are observed. |
before start exercises
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Pelvic Type Assessment, result based on the evaluation of the height of the hip plates relative to the L4/L5 vertebra, there is no measure or unit here.
Tidsram: before start exercises
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The subject is standing and the examiner must identify the fourth and fifth lumbar vertebrae. Pelvic assessment is carried out according to Lewitt. Pelvis normal: If the iliac crests are at the height of the fourth and fifth lumbar vertebrae.The pelvis is highly assimilated when the iliac crests fall above the fourth and fifth lumbar vertebrae.Pelvic overload when the iliac crests fall below the fourth and fifth lumbar vertebrae. |
before start exercises
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Postural stability assessment, measurement in the form of a number, the manufacturer does not provide measurement units.
Tidsram: before start exercises and after six week finish exercises
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Posturomed stablometric platform will be used to assess postural stability. Posturomed stablometric platform will be used to assess postural stability |
before start exercises and after six week finish exercises
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Agata Wojtczak, Student Research Centre Conocimiento, Faculty of Sport Sciences in Gorzow Wielkopolski
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Manliga urogenitala sjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urineringsstörningar
- Symtom i de nedre urinvägarna
- Urologiska manifestationer
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Urininkontinens
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Terapeutik
- Rehabilitering
- Utöva
- Fysioterapimetoder
Andra studie-ID-nummer
- 2024
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
- gathered groups.
- pre-exercise evaluation.
- exercises.
- post-exercise evaluation.
- Statistical compilation of data.
- Presentation of results at scientific conferences and in a scientific journal as a publication.
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