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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
25
Daily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week.
Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training
Department of Public Health and General Practice
Trondheim, Norway
Anal incontinence
St. Marks score
Time frame: 3 months post surgery
Anal incontinence
St. Marks score
Time frame: 12 months post surgery
Urinary incontinence
International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI/SF)
Time frame: 3 and 12 months post surgery
Bowel dysfunction
Low anterior resection syndrome score (LARS)
Time frame: 3 and 12 months post surgery
Physiology of the anal sphincter
Anal manometry
Time frame: 3 and 12 months post surgery
Sexual dysfunction
The International Index of Erectile Function (IIEF) for men and the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) (PISQ-IR) for women
Time frame: 3 and 12 months post surgery
Quality of life
The 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).
Time frame: 3 and 12 months post surgery
Maximal oxygen uptake (VO2max)
Cardiopulmonary exercise test
Time frame: On an average 1 week pre surgery
Postoperative complications
International Statistical Classification of Diseases and Related Health problems, 10th revision (ICD-10) diagnostic codes, from the patient records
Time frame: Up to five years post surgery
Physical activity level
Activity monitor (SenseWear) to measure level of daily physical activity
Time frame: On an average 1 week pre surgery and three months post surgery
In-hospital time
Number of days in hospital from the patient records
Time frame: Up to 12 months post surgery
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