Functional Constipation and Fall-Related Outcomes in Older Adults

NCT07630740 — Active not recruiting, 208 participants, Izmir Bakircay University

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

Registry	NCT07630740, acronym FC-FALLS
Status	Active not recruiting
Study type	Observational
Enrollment	208 (Actual)
Sponsor	Izmir Bakircay University (Other)
Conditions	Functional Constipation (FC), Accidental Falls, Physical Functional Performance
Dates	start 2026-05-15, primary completion 2026-09-15 (estimated), completion 2026-11-15 (estimated), first posted 2026-06-05, last updated 2026-06-05
Locations	1 site in Turkey (Türkiye)

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

Presence of Functional Constipation According to the Rome IV Criteria [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.

Secondary outcomes

Fall History Within the Last 12 Months [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.
Functional Capacity Assessed by the 6-Minute Walk Test [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.
Lower Extremity Functional Performance Assessed by the Five Times Sit-to-Stand Test [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
Physical Activity Level Assessed by the International Physical Activity Questionnaire [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.

+Eligibility

Sex: All, ages: 65 Years to 80 Years

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

+Locations (1)

Facility	City	Country	Status
zmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center	Izmir, İzmir	Turkey (Türkiye)