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Active, Not Recruiting

NCT Number: NCT07630740

Functional Constipation and Fall-Related Outcomes in Older Adults

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Functional Constipation (FC) Accidental Falls Behavior Motor Activity Physical Functional Performance

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

zmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center

Izmir, İzmir, 35353, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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

  1. Fall History Within the Last 12 Months

    Time frame: 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.

  2. Functional Capacity Assessed by the 6-Minute Walk Test

    Time frame: 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.

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

    Time frame: 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

  4. Physical Activity Level Assessed by the International Physical Activity Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

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

Acronym: FC-FALLS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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