Functional Constipation (FC)FC-FALLSNCT07630740
Functional Constipation and Fall-Related Outcomes in Older Adults
An observational study of Functional Constipation (FC) and Accidental Falls, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Functional Constipation (FC), Accidental Falls, Physical Functional Performance
- Type of treatment
- Injection or infusion
- How many people
- 208 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
zmir Bakircay University Physiotherapy and Rehabilitation Application and Research Center
Izmir, İzmir, 35353
About this study
Official 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
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.
Read more
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.
- Keywords
- Rome IV Criteria, Functional Constipation, Five Times Sit-to-Stand Test, Physical Activity, Older Adults, Fall History
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At routine clinical assessment between April 2024 and April 2026
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At routine clinical assessment between April 2024 and April 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start15 May 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYŞE KAYALI VATANSEVER, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630740
- Sponsor's protocol ID
- 2933
- Acronym
- FC-FALLS
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07630740
- Acronym / sponsor ID
- FC-FALLS / 2933
- Keywords
- Rome IV Criteria, Functional Constipation, Five Times Sit-to-Stand Test, Physical Activity, Older Adults, Fall History
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Fall History Within the Last 12 Months
Time frame: At routine clinical assessment between April 2024 and April 2026
Functional Capacity Assessed by the 6-Minute Walk Test
Time frame: At routine clinical assessment between April 2024 and April 2026
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
Physical Activity Level Assessed by the International Physical Activity Questionnaire
Time frame: At routine clinical assessment between April 2024 and April 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Constipation (FC) and Accidental Falls, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Functional Constipation According to the Rome IV Criteria (time frame: At routine clinical assessment between April 2024 and April 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.