Functional Constipation and Fall-Related Outcomes in Older Adults (FC-FALLS)
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.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
İzmir
-
Izmir, İzmir, Tyrkia (Türkiye), 35353
- zmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Presence of Functional Constipation According to the Rome IV Criteria
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fall History Within the Last 12 Months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2933
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .