Trials / Terminated
TerminatedNCT02538913
Exercise Training for Rectal Cancer Patients
Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Norwegian University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2020-01-01
- Completion
- 2020-01-01
- First posted
- 2015-09-02
- Last updated
- 2020-11-17
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT02538913. Inclusion in this directory is not an endorsement.