Functional Constipation and Fall-Related Outcomes in Older Adults

NCT07630740 | Active Not Recruiting

• 1 other identifier: 2933
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Constipation (FC); Accidental Falls; Physical Functional Performance

Keywords

Rome IV Criteria; Functional Constipation; Five Times Sit-to-Stand Test; Physical Activity; Older Adults, Fall History

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Fall History Within the Last 12 Months

  At routine clinical assessment between April 2024 and April 2026

• Functional Capacity Assessed by the 6-Minute Walk Test

  At routine clinical assessment between April 2024 and April 2026

• Lower Extremity Functional Performance Assessed by the Five Times Sit-to-Stand Test

  At routine clinical assessment between April 2024 and April 2026

• Physical Activity Level Assessed by the International Physical Activity Questionnaire

  At routine clinical assessment between April 2024 and April 2026

Study Arms (2)

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.

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

zmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center

Izmir, İzmir, 35353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor / Principal Investigator

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)