Exercise Training for Rectal Cancer Patients

NCT02538913 | Terminated

• 1 other identifier: 2014/2284
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Anal incontinence

  St. Marks score

  3 months post surgery

Secondary Outcomes (10)

• Anal incontinence

  12 months post surgery

• Urinary incontinence

  3 and 12 months post surgery

• Bowel dysfunction

  3 and 12 months post surgery

• Physiology of the anal sphincter

  3 and 12 months post surgery

• Sexual dysfunction

  3 and 12 months post surgery

Study Arms (2)

Exercise training

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.

Behavioral: Exercise training; Procedure: Usual care

Usual care

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

Procedure: Usual care

Interventions

Exercise training BEHAVIORAL

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

Exercise training

Usual care PROCEDURE

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

Exercise training; Usual care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Department of Public Health and General Practice

Trondheim, 7489, Norway

Location

MeSH Terms

Conditions

Rectal Neoplasms; Motor Activity; Fecal Incontinence; Urinary Incontinence; Sexual Dysfunction, Physiological

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Behavior; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Siri Forsmo, PhD, MD

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

NO (1)