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Functional Constipation and Fall-Related Outcomes in Older Adults (FC-FALLS)

2 juni 2026 bijgewerkt door: AYŞE KAYALI VATANSEVER, Izmir Bakircay University

The Relationship Between Rome IV Functional Constipation and Fall History, Functional Capacity, and Physical Activity in Older Adults: A Retrospective Cross-Sectional Analytical Study

This retrospective cross-sectional observational study aims to examine the relationship between Rome IV functional constipation and fall history, functional capacity, and physical activity in older adults.

The study will use routinely recorded clinical data from older adults aged 65 to 80 years who attended the Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center between April 2024 and April 2026. No new intervention, treatment, exercise program, drug, or device will be applied as part of this study.

Functional constipation will be evaluated using bowel habit data recorded in patient files and classified according to the Rome IV criteria. Fall history within the last 12 months will be obtained from routine clinical records. Functional capacity will be assessed using recorded results from the 6-Minute Walk Test and the Five Times Sit-to-Stand Test. Physical activity level will be evaluated using available International Physical Activity Questionnaire data.

The study will include data from 208 eligible older adults. The main purpose is to determine whether older adults with Rome IV functional constipation differ from those without functional constipation in terms of fall history, walking capacity, lower extremity functional performance, and physical activity level. The findings may help clarify whether functional constipation in older adults is associated not only with bowel habits but also with broader geriatric and rehabilitation-related outcomes.

Studie Overzicht

Studietype

Observationeel

Inschrijving (Werkelijk)

208

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • İzmir
      • Izmir, İzmir, Turkije (Türkiye), 35353
        • zmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population will consist of older adults aged 65 to 80 years who attended the Izmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center between April 2024 and April 2026 and whose routinely recorded clinical data meet the study eligibility criteria. Participants will be identified retrospectively from patient files and standard clinical assessment records. All eligible consecutive cases with sufficient data on bowel habits, fall history, functional capacity, and physical activity will be included.

Beschrijving

Inclusion Criteria:

Being between 65 and 80 years of age Having routinely recorded bowel habit data sufficient to evaluate Rome IV functional constipation criteria Having routinely recorded data on fall history, functional capacity, and physical activity in patient records

Exclusion Criteria:

Having missing data at a level that prevents analysis of the main study variables Having an active cancer diagnosis or attending the center for reasons related to cancer treatment Having undergone major surgery within the last 12 months Having received regular physiotherapy or rehabilitation services for any reason within the last 12 months

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Older Adults With Rome IV Functional Constipation
Older adults aged 65 to 80 years whose routinely recorded bowel habit data meet the Rome IV criteria for functional constipation. No intervention will be administered. Retrospective clinical records will be used to evaluate fall history, functional capacity, and physical activity.
Older Adults Without Rome IV Functional Constipation
Older adults aged 65 to 80 years whose routinely recorded bowel habit data do not meet the Rome IV criteria for functional constipation. No intervention will be administered. Retrospective clinical records will be used to evaluate fall history, functional capacity, and physical activity.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Presence of Functional Constipation According to the Rome IV Criteria
Tijdsspanne: At routine clinical assessment between April 2024 and April 2026
Functional constipation status will be determined retrospectively using routinely recorded bowel habit data from patient files. Participants will be classified as having or not having functional constipation according to the Rome IV criteria, including recorded data on straining, hard or lumpy stools, sensation of incomplete evacuation, sensation of anorectal blockage, need for manual maneuvers, fewer than three spontaneous bowel movements per week, rarity of loose stools without laxatives, insufficient criteria for irritable bowel syndrome, and symptom duration criteria.
At routine clinical assessment between April 2024 and April 2026

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fall History Within the Last 12 Months
Tijdsspanne: At routine clinical assessment between April 2024 and April 2026
Fall history will be obtained retrospectively from routine clinical records. Falls will be recorded as the presence or absence of at least one fall within the last 12 months.
At routine clinical assessment between April 2024 and April 2026
Functional Capacity Assessed by the 6-Minute Walk Test
Tijdsspanne: At routine clinical assessment between April 2024 and April 2026
Functional capacity will be evaluated using retrospectively recorded 6-Minute Walk Test results. The total walking distance completed in 6 minutes will be recorded in meters.
At routine clinical assessment between April 2024 and April 2026
Lower Extremity Functional Performance Assessed by the Five Times Sit-to-Stand Test
Tijdsspanne: At routine clinical assessment between April 2024 and April 2026
Lower extremity functional performance will be evaluated using retrospectively recorded Five Times Sit-to-Stand Test results. The time required to complete five consecutive sit-to-stand repetitions will be recorded in seconds. Use of hand support during the test will also be recorded if available
At routine clinical assessment between April 2024 and April 2026
Physical Activity Level Assessed by the International Physical Activity Questionnaire
Tijdsspanne: At routine clinical assessment between April 2024 and April 2026
Physical activity level will be evaluated retrospectively using available International Physical Activity Questionnaire data recorded during routine clinical assessment.
At routine clinical assessment between April 2024 and April 2026

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 mei 2026

Primaire voltooiing (Geschat)

15 september 2026

Studie voltooiing (Geschat)

15 november 2026

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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