Exercise Training for Rectal Cancer Patients

NCT02538913 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-11-17

No results posted yet for this study

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.

Conditions

  • Rectal Neoplasms

Interventions

BEHAVIORAL

Exercise training

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

PROCEDURE

Usual 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 & Collaborators

  • St. Olavs Hospital

    collaborator OTHER
  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Siri Forsmo, PhD, MD · Norwegian University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02538913 on ClinicalTrials.gov