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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Functional Performance; Accidental Falls; Functional Constipation (FC)

• Study Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Functional Constipation According to the Rome IV Criteria	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall History Within the Last 12 Months	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	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	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	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

Collaborators and Investigators

• Sponsor: Izmir Bakircay University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Rome IV Criteria; Functional Constipation; Five Times Sit-to-Stand Test; Older Adults, Fall History
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 2933

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No