Rectal CancerNCT07732894
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
A study testing Exercise and guided imagery in people with Rectal Cancer and Fecal Incontinence and Constipation, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Low Anterior Resection Syndrome (LARS) is a common complication after sphincter-preserving rectal cancer surgery and may negatively affect bowel function and quality of life. Although exercise has been shown to improve physical function and well-being in cancer survivors, evidence regarding its effects on LARS… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rectal Cancer, Fecal Incontinence and Constipation, Aerobic Exercise
- What is being tested?
- Exercise and guided imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2025to 30 May 2027
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper-Middle-Lower Rectal Cancer
- Having undergone surgery with TMJ
- Having a protective ileostomy and a closed stoma
- Being tumor-free according to laboratory reports (carcinoembryonic antigen), endoscopic findings, and abdominal ultrasonography and/or computed tomography data
- Having at least minor LARS scores ("between 21" and "42") according to the -LARS scoring questionnaire
- Having the ability to perform voluntary perineal traction contractions with perineal palpation
- Being a volunteer with informed consent
Who cannot join
- History of incontinence or defecation disorder not related to rectal cancer
- Having another type of surgery for rectal cancer (Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgical resection, or sigmoid resection)
- Deterioration in general health, neurological disease and/or physical disability
- BMI > 30 kg/m2 (obese individuals)
- Inability to answer questions or make interventions due to mental disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zeynep Hoşbay, professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Memorial Bahçelievler Hospital
Istanbul
burçin özyürek, 05367149912, burcinozyurek@gmail.com
About this study
Official title: "The Effects of Aerobic Exercise and Guided Imagery on Low Anterior Resection Syndrome After Rectal Cancer Surgery: A Randomized Controlled Study"
Low Anterior Resection Syndrome (LARS) is a common complication after sphincter-preserving rectal cancer surgery and may negatively affect bowel function and quality of life. Although exercise has been shown to improve physical function and well-being in cancer survivors, evidence regarding its effects on LARS symptoms remains limited.
This randomized controlled, multicenter study aims to evaluate the effects of an aerobic exercise program combined with guided imagery on bowel symptoms, quality of life, physical activity level, functional capacity, and psychological well-being in patients with LARS after rectal cancer surgery. Participants will be randomly assigned to either an intervention group receiving aerobic exercise and guided imagery in addition to standard care or a control group receiving standard care alone. Outcomes will be assessed at baseline and after the intervention period using validated clinical and patient-reported outcome measures.
The findings of this study may contribute to the development of evidence-based rehabilitation strategies for improving bowel function and quality of life in patients with LARS following rectal cancer surgery.
- Conditions
- Rectal Cancer, Fecal Incontinence and Constipation, Aerobic Exercise, Guided Imagery Exercise, Pelvic Floor Physical Therapy, Pelvic Floor Muscle Training
- Being tested
- Exercise, guided imagery
- Keywords
- rectal cancer, low anterior resection syndrome, aerobic exercise, guided imagery, pelvic floor muscle training, pelvic floor rehabilitation, pelvic floor physical therapy
- Medical subject headings
- Rectal Neoplasms, Fecal Incontinence, Constipation, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called aerobic exercise
structured walking exercise, at the clinic and outside from the clinic for at least 3 days /week
guided imageryBehavioural
guided imagery for at least 3 days
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise and guided imagery group in addition to standart care | Experimental | Participants will receive an aerobic exercise program combined with guided imagery in addition to standard postoperative care. The intervention will be delivered according to the study protocol throughout the intervention period. Receives: Other: Exercise; Behavioral: guided imagery |
| standart care group | No intervention | Participants will receive standard postoperative care without the structured aerobic exercise or guided imagery during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Anterior Resection Sydrome scoring system
It measures the intensity of low anterior resection syndrome. The score varies between "0" and "42". Higher scores indicates more severe symptoms.
Measured: "From enrollment to the end of treatment at 8 weeks"
European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-30
It measures the quality of life in cancer patients. The scores range from 0 to 100. For the Global Health Status and Functional Scales, higher scores indicate better health-related quality of life and functioning, whereas for the Symptom Scales, higher scores indicate greater symptom burden.
Measured: 8 weeks from beginning the study
European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-29
It measures the quality of life in cancer patients. The EORTC QLQ-CR29 scores range from 0 to 100. Higher scores on the functional scales indicate better functioning, whereas higher scores on the symptom scales indicate greater symptom burden.
Measured: 8 weeks
6 minutes walking test
It measures the aerobic capacity within 6 minutes. The 6-Minute Walk Test (6MWT) assesses functional exercise capacity by measuring the total distance walked in meters over six minutes. There is no maximum value. Higher distances indicate better functional exercise capacity.
Measured: 8 weeks
Secondary outcomes (5)
colorectoanal distress inventory
It measures the intensity of anorectal symptoms. The score ranges from 0 to 100, with higher scores indicating greater colorectal and anal symptom distress.
Measured: 8 weeks
wexner questionnaire
It measures the intensity of fecal incontinence. The score ranges from 0 to 20, with higher scores indicating greater severity of fecal incontinence.
Measured: 8 weeks
International Physical Activity Questionnaire-short form
It measures the level of physical activity level. The questionnaire assesses physical activity levels in MET-minutes/week.Higher MET-minutes/week indicate greater physical activity.
Measured: 8 weeks
Hospital Anxiety and Depression Scale
It measures the level of depression and anxiety. The Hospital Anxiety and Depression Scale (HADS) consists of two subscales (anxiety and depression), each ranging from 0 to 21. Higher scores indicate greater symptoms of anxiety or depression.
Measured: 8 weeks
pelvic floor muscle function via biofeedback
It measures the strength of pelvic floor muscles. Pelvic floor muscle activity by using surface electromyography (sEMG) are reported in microvolts (µV). Therefore, there is no any min-max value. Higher EMG amplitudes indicate greater pelvic floor muscle activation.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start30 Dec 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep HOŞBAY, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732894
- Sponsor's protocol ID
- Biruni.
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effects of Aerobic Exercise and Guided Imagery on Low Anterior Resection Syndrome After Rectal Cancer Surgery: A Randomized Controlled Study"
- ClinicalTrials.gov ID
- NCT07732894
- Acronym / sponsor ID
- Biruni.
- Conditions
- Rectal Cancer, Fecal Incontinence and Constipation, Aerobic Exercise, Guided Imagery Exercise, Pelvic Floor Physical Therapy, Pelvic Floor Muscle Training
- Keywords
- rectal cancer, low anterior resection syndrome, aerobic exercise, guided imagery, pelvic floor muscle training, pelvic floor rehabilitation, pelvic floor physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 29 Jul 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.
Low Anterior Resection Syndrome (LARS) is a common complication after sphincter-preserving rectal cancer surgery and may negatively affect bowel function and quality of life. Although exercise has been shown to improve physical function and well-being in cancer survivors, evidence regarding its effects on LARS symptoms remains limited.
This randomized controlled, multicenter study aims to evaluate the effects of an aerobic exercise program combined with guided imagery on bowel symptoms, quality of life, physical activity level, functional capacity, and psychological well-being in patients with LARS after rectal cancer surgery. Participants will be randomly assigned to either an intervention group receiving aerobic exercise and guided imagery in addition to standard care or a control group receiving standard care alone. Outcomes will be assessed at baseline and after the intervention period using validated clinical and patient-reported outcome measures.
The findings of this study may contribute to the development of evidence-based rehabilitation strategies for improving bowel function and quality of life in patients with LARS following rectal cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise and guided imagery group in addition to standart care | Experimental | Other: Exercise, Behavioral: guided imageryParticipants will receive an aerobic exercise program combined with guided imagery in addition to standard postoperative care. The intervention will be delivered according to the study protocol throughout the intervention period. |
| standart care group | No intervention | –Participants will receive standard postoperative care without the structured aerobic exercise or guided imagery during the study period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Upper-Middle-Lower Rectal Cancer
- Having undergone surgery with TMJ
- Having a protective ileostomy and a closed stoma
- Being tumor-free according to laboratory reports (carcinoembryonic antigen), endoscopic findings, and abdominal ultrasonography and/or computed tomography data
- Having at least minor LARS scores ("between 21" and "42") according to the -LARS scoring questionnaire
Key exclusion criteria (5 listed)
- History of incontinence or defecation disorder not related to rectal cancer
- Having another type of surgery for rectal cancer (Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgical resection, or sigmoid resection)
- Deterioration in general health, neurological disease and/or physical disability
- BMI > 30 kg/m2 (obese individuals)
- Inability to answer questions or make interventions due to mental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: aerobic exercisestructured walking exercise, at the clinic and outside from the clinic for at least 3 days /week | Other | aerobic exercise and guided imagery group in addition to standart care |
| guided imageryguided imagery for at least 3 days | Behavioural | aerobic exercise and guided imagery group in addition to standart care |
Primary outcome
Low Anterior Resection Sydrome scoring system
Time frame: "From enrollment to the end of treatment at 8 weeks"
It measures the intensity of low anterior resection syndrome. The score varies between "0" and "42". Higher scores indicates more severe symptoms.
European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-30
Time frame: 8 weeks from beginning the study
It measures the quality of life in cancer patients. The scores range from 0 to 100. For the Global Health Status and Functional Scales, higher scores indicate better health-related quality of life and functioning, whereas for the Symptom Scales, higher scores indicate greater symptom burden.
European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire-29
Time frame: 8 weeks
It measures the quality of life in cancer patients. The EORTC QLQ-CR29 scores range from 0 to 100. Higher scores on the functional scales indicate better functioning, whereas higher scores on the symptom scales indicate greater symptom burden.
6 minutes walking test
Time frame: 8 weeks
It measures the aerobic capacity within 6 minutes. The 6-Minute Walk Test (6MWT) assesses functional exercise capacity by measuring the total distance walked in meters over six minutes. There is no maximum value. Higher distances indicate better functional exercise capacity.
5 secondary outcomes
colorectoanal distress inventory
Time frame: 8 weeks
wexner questionnaire
Time frame: 8 weeks
International Physical Activity Questionnaire-short form
Time frame: 8 weeks
Hospital Anxiety and Depression Scale
Time frame: 8 weeks
pelvic floor muscle function via biofeedback
Time frame: 8 weeks
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 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Zeynep Hoşbay, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and guided imagery in people with Rectal Cancer and Fecal Incontinence and Constipation, run by Biruni 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Jul 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?
Contact Burçin Özyürek, Master of Science (+905367149912, burcinozyurek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Anterior Resection Sydrome scoring system (time frame: "From enrollment to the end of treatment at 8 weeks"). The study lists 4 primary outcomes in all. 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 29 Jul 2026.