- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07630740
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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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İzmir
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Izmir, İzmir, Turquía (Türkiye), 35353
- zmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Presence of Functional Constipation According to the Rome IV Criteria
Periodo de tiempo: At routine clinical assessment between April 2024 and April 2026
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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.
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At routine clinical assessment between April 2024 and April 2026
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fall History Within the Last 12 Months
Periodo de tiempo: At routine clinical assessment between April 2024 and April 2026
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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.
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At routine clinical assessment between April 2024 and April 2026
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Functional Capacity Assessed by the 6-Minute Walk Test
Periodo de tiempo: At routine clinical assessment between April 2024 and April 2026
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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.
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At routine clinical assessment between April 2024 and April 2026
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Lower Extremity Functional Performance Assessed by the Five Times Sit-to-Stand Test
Periodo de tiempo: At routine clinical assessment between April 2024 and April 2026
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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
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At routine clinical assessment between April 2024 and April 2026
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Physical Activity Level Assessed by the International Physical Activity Questionnaire
Periodo de tiempo: At routine clinical assessment between April 2024 and April 2026
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Physical activity level will be evaluated retrospectively using available International Physical Activity Questionnaire data recorded during routine clinical assessment.
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At routine clinical assessment between April 2024 and April 2026
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2933
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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