- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05339516
The Association Between Urinary Incontinence, Physical Performance, Physical Activity Levels in Women With Low Back Pain
The Association Between Urinary Incontinence, Physical Performance and Physical Activity Level in Women With Low Back Pain a Cross-Sectional Study
Studienübersicht
Status
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Pinar Yasar, MSc
- Telefonnummer: +905350145340
- E-Mail: pinarergoz@gmail.com
Studienorte
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Isparta, Truthahn, 32100
- Rekrutierung
- Faculty of Health Sciences
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Kontakt:
- Pınar Yasar, MSc
- Telefonnummer: +905350145340
- E-Mail: pinarergoz@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria For Healthy Group:
- 30-65 years women
- Agreeing to involve in the study
Inclusion Criteria For Women With Low Back Pain Group:
- 30-65 years women
- Having low back pain for at least 3 months
- Scoring pain at least 1 in Visual Analog Scale(VAS)
- Agreeing to involve in the study
Exclusion Criteria:
- Any kind of surgery history in low back area
- Surgery history in lower limbs
- Acute low back pain
- Having a neurological disease
- Having sensory deficists
- The ones with rheumatological diseases which can cause low back pain
- Being pregnant
- Having a disc hernia pressuring to sacral nerves
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Querschnitt
Kohorten und Interventionen
Gruppe / Kohorte |
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Gesunde Gruppe
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Women with low back pain
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Visual Analog Scale(VAS)
Zeitfenster: Baseline
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Visual Analogue Scale (VAS) will be used to evaluate the severity of low back pain.
The back pain they feel during activity and rest will be questioned separately from the participants.
For this assessment, patients will be asked to mark their pain intensity on a 10-centimeter line.
Pain intensity will be determined by measuring the distance of the marked point to the "0" point with a tape measure.
Scoring is made between 0-10 and "0 means no pain"- "10 means the most severe pain imaginable".
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Baseline
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International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Zeitfenster: Baseline
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The six-question form allows evaluation of the frequency of urinary incontinence and during which activities it occurs.
The validity and reliability study of the Turkish version of the test was done by Çetinel et al. made by Scoring is done with frequency, amount and degree of impact questions, a total score between 0-21 is obtained.
A low score indicates that urinary incontinence affects the quality of life less, and a high score indicates that the involvement is high.
For the ICIQ-SF, a score of 8 and above was determined as the most appropriate cut-off value for irritating urine leakage.
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Baseline
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International Physical Activity Questionnaire(IPAQ)
Zeitfenster: Baseline
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The physical activity level of the participants will be evaluated with the International Physical Activity Questionnaire (IPAQ).
The survey consists of a total of 5 sections and 27 questions.
Information is obtained about the light, moderate and vigorous activities that the person has done in the last week and the sitting time.
For physical activities performed for at least 10 minutes, the MET value (metabolic equivalent) is multiplied by the number of days and minutes to obtain the MET-min/week score.
Classification according to the energy level spent in METs is made as no physical activity (MET=<600), insufficient activity (MET=600-3000), and adequate activity level (MET= >3000).
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Baseline
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Muscle Strength Testing
Zeitfenster: Baseline
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The muscle strength of the participants will be determined by the Manual Muscle Test.
The person is asked to move against gravity by taking the appropriate position for the muscle to be evaluated.
If the movement can be done up to the desired part (3) it is scored as medium, if it receives minimal resistance (3+) if it gets a little good from the middle, if it can get moderate resistance (4) good, if it can get full resistance (5) it is normal.
Muscle strength of the shoulder and elbow flexors in the upper extremity and hip flexors in the lower extremities will be evaluated.
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Baseline
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Endurance Testing
Zeitfenster: Baseline
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Trunk Flexor Endurance test and Wall-Sit-Hold Test will be used to evaluate trunk and lower extremity endurance. Wall-Sit- Hold Test: The participant leans his back against the wall, spreads his feet shoulder-width apart and squats by bringing his knees to 90 degrees of flexion. The time during which the position can be held is recorded |
Baseline
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Agility Testing
Zeitfenster: Baseline
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Burpee Agility Test will be used for the agility evaluation of the participants.
The test consists of 4 stages.
Initially, the standing participant moves into a half-squat position, then into a stance on the floor with hands and feet close together.
Then the participant takes the plank position with the arms fully extended by throwing his legs back and then returning to the previous position.
He then stands up and returns to the starting position and claps his hands above his head once.
The standard test duration is 3 minutes, but a modified version of 1 minute will be used in order to be applicable to individuals with low physical activity.
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Baseline
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Flexibility Testing
Zeitfenster: Baseline
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Flexibility will be assessed with the sit and reach test.
The person sits in a long sitting position with his legs straight, the soles of the feet are in contact with the 31 cm high evaluation table.
The participant is then asked to reach forward as far as he can, keeping his knees straight, with one hand on the other.
Starting position and the farthest point that the middle finger can reach at the end of the movement is measured and the difference is recorded.
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Baseline
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 72867572-050.01.04-
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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