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Exercise Training for Rectal Cancer Patients

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02538913
Enrollment
25
Registered
2015-09-02
Start date
2015-09-30
Completion date
2020-01-31
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neoplasms

Keywords

Exercise, Pelvic floor, Prehabilitation, Fecal incontinence, Urinary incontinence, Sexual dysfunction, physiological

Brief summary

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.

Interventions

BEHAVIORALExercise training

Daily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week.

PROCEDUREUsual care

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

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Cancer recti * Planned curative LAR with preoperative radiotherapy * Cancer stadium I-III * Able to speak and understand Norwegian

Exclusion criteria

* Previous radiotherapy * Previous pelvic surgery * Diseases affecting the anal sphincter

Design outcomes

Primary

MeasureTime frameDescription
Anal incontinence3 months post surgerySt. Marks score

Secondary

MeasureTime frameDescription
Urinary incontinence3 and 12 months post surgeryInternational Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF)
Bowel dysfunction3 and 12 months post surgeryLow anterior resection syndrome score (LARS)
Physiology of the anal sphincter3 and 12 months post surgeryAnal manometry
Sexual dysfunction3 and 12 months post surgeryThe International Index of Erectile Function (IIEF) for men and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) (PISQ-IR) for women
Anal incontinence12 months post surgerySt. Marks score
Maximal oxygen uptake (VO2max)On an average 1 week pre surgeryCardiopulmonary exercise test
Postoperative complicationsUp to five years post surgeryInternational Statistical Classification of Diseases and Related Health problems, 10th revision (ICD-10) diagnostic codes, from the patient records
Physical activity levelOn an average 1 week pre surgery and three months post surgeryActivity monitor (SenseWear) to measure level of daily physical activity
In-hospital timeUp to 12 months post surgeryNumber of days in hospital from the patient records
Quality of life3 and 12 months post surgeryThe European Organization for Research and Treatment of Cancer Quality of Life core questionnaire (EORTC QLQ-C30) and the colorectal cancer specific Quality of Life Questionnaire (QLQ-C38).

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026