Exercise Training for Rectal Cancer Patients

NCT ID: NCT02538913

Last Updated: 2020-11-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2020-01-31

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.

Conditions

Rectal Neoplasms

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Exercise training

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 Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

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

Usual care

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: PROCEDURE

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

Interventions

Exercise training

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

Intervention Type: BEHAVIORAL

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siri Forsmo, PhD, MD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

Department of Public Health and General Practice

Trondheim, , Norway

Countries

Norway

Other Identifiers

2014/2284

Identifier Type: -

Identifier Source: org_study_id