Suspended

Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.

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What is being tested

Exercise training

+ Usual care

BehavioralProcedure
Who is being recruted

Urogenital Diseases+24

+ Genital Diseases

+ Behavior

From 18 to 80 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2015
See protocol details

Summary

Principal SponsorNorwegian University of Science and Technology
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2015

Actual date on which the first participant was enrolled.

Cancer treatments often cause acute toxicity during treatment, and late toxicity after treatments have ended. Bowel dysfunctions, incontinence (anal and urinary) and dysfunction are late side effects associated with cancer treatment in general, and patients treated for pelvic malignancies are at a higher risk. In Norway, the incidence of rectal cancer was 1329 in 2010. Advances in the treatment during the past few decades have led to fewer local recurrences and increased long-term survival, and today the relative survival is 66% for women and 64% for men. More patients are having sphincter-preserving surgery with low colorectal or ultralow coloanal anastomoses, and low anterior resection (LAR) is done in 70% of the patients with curative surgery. Unfortunately, many patients experience altered bowel function after LAR. Frequent bowel movements, urgency, evacuatory difficulties and fecal incontinence are common and distressing complications. These functional disturbances are seen in up to 50-60% of the patients, and most frequent when surgery is combined with neoadjuvant therapy. Urinary incontinence and decreased sexual function is also common in both men and women following rectal cancer treatment. In many surgical settings, patients with higher preoperative physical fitness rehabilitate more quickly and have fewer operative complications compared with patients who are less physically fit. Additionally, specific strength training of the pelvic floor muscles builds up muscle volume, elevates the location of the pelvic floor muscles and pelvic organs, and closes the levator hiatus thus providing improved structural support for the pelvic floor as well as more optimal automatic function. The aim of the present trial is to investigate whether exercise training including pelvic floor muscle training during preoperative radiotherapy can reduce symptoms of bowel, urinary and sexual dysfunction and affect the physiology of the anal sphincter muscle after LAR. In addition quality of life, cardiopulmonary parameters and postoperative complications will be studied.

Official TitleExercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.
NCT02538913
Principal SponsorNorwegian University of Science and Technology
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBehaviorDigestive System DiseasesDigestive System NeoplasmsFecal IncontinenceFemale Urogenital Diseases and Pregnancy ComplicationsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsMotor ActivityNeoplasmsNeoplasms by SiteRectal DiseasesRectal NeoplasmsSexual Dysfunction, PhysiologicalSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination DisordersUrologic DiseasesColorectal NeoplasmsUrological ManifestationsFemale Urogenital DiseasesMale Urogenital DiseasesLower Urinary Tract Symptoms

Criteria

4 inclusion criteria required to participate
Cancer recti

Planned curative LAR with preoperative radiotherapy

Cancer stadium I-III

Able to speak and understand Norwegian

3 exclusion criteria prevent from participating
Previous radiotherapy

Previous pelvic surgery

Diseases affecting the anal sphincter

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients randomized to the exercise training group will be individually instructed in correct pelvic floor muscle contractions and intensive pelvic floor muscle training to perform daily. In addition they will be encouraged to exercise regularly ≥3 days/week. The exercise program will be individualized and consisting of both aerobic and strength exercise training.

Group II

Active Comparator
Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Public Health and General Practice

Trondheim, NorwayOpen Department of Public Health and General Practice in Google Maps
SuspendedOne Study Center