ClinicalTrials.gg
RecruitingNCT07732894Updated Jul 29, 2026

Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome

An interventional study of Exercise and guided imagery in Rectal Cancer, Fecal Incontinence and Constipation and Aerobic Exercise, sponsored by Biruni University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Biruni University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Dec 2025, registered Jul 2026).
  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Rectal Neoplasms

2,400 studies on the registry are indexed under Rectal Neoplasms; 587 are open to participants now.

This study's planned enrollment of 50 is below the median of 65 across 1,751 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Biruni University is the lead sponsor of 180 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • > 30 kg/m2 (obese individuals)
  • Inability to answer questions or make interventions due to mental disorder
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    aerobic exercise and guided imagery group in addition to standart care

    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.

    Other: Exercise · Behavioral: guided imagery

  • No intervention
    standart care group

    Participants will receive standard postoperative care without the structured aerobic exercise or guided imagery during the study period.

Interventions

  • OtherExercise

    structured walking exercise, at the clinic and outside from the clinic for at least 3 days /week

    Also known as: aerobic exercise

  • Behavioralguided imagery

    guided imagery for at least 3 days

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: "From enrollment to the end of treatment at 8 weeks"

  2. 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.

    Time frame: 8 weeks from beginning the study

  3. 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.

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

  5. 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.

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.

Of 329 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 78. This study's planned 12 months is below that.

Counting every sponsor, half of 336 studies reached it within 51 months; a quarter within 23 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2026
First posted
Jul 29, 2026
StartActual
Dec 30, 2025
Primary completionEst.
Dec 30, 2026
CompletionEst.
May 30, 2027
Last update
Jul 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07732894
Lead sponsor
Biruni University
Responsible party
Zeynep HOŞBAY (professor, Biruni University) — Principal investigator
First posted
Jul 29, 2026
Start date
Dec 30, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
May 30, 2027 (estimated)
Last update
Jul 29, 2026

Study contacts

Burçin Özyürek, Master of Science
Contact
burcinozyurek@gmail.com
+905367149912
Zeynep Hoşbay, professor
Contact
zhosbay@biruni.edu.tr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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