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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02538913
Date of registration:	26/08/2015
Prospective Registration:	Yes
Primary sponsor:	Norwegian University of Science and Technology
Public title:	Exercise Training for Rectal Cancer Patients
Scientific title:	Exercise Training for Rectal Cancer Patients. A Randomized Controlled Trial.
Date of first enrolment:	September 2015
Target sample size:	25
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT02538913
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
Phase:	N/A

Countries of recruitment
Norway

Contacts

Name:	Siri Forsmo, PhD, MD
Address:
Telephone:
Email:
Affiliation:	Norwegian University of Science and Technology

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rectal Neoplasms

Intervention(s)

Procedure: Usual care

Behavioral: Exercise training

Primary Outcome(s)

Anal incontinence [Time Frame: 3 months post surgery]

Secondary Outcome(s)

In-hospital time [Time Frame: Up to 12 months post surgery]

Postoperative complications [Time Frame: Up to five years post surgery]

Urinary incontinence [Time Frame: 3 and 12 months post surgery]

Anal incontinence [Time Frame: 12 months post surgery]

Sexual dysfunction [Time Frame: 3 and 12 months post surgery]

Bowel dysfunction [Time Frame: 3 and 12 months post surgery]

Physical activity level [Time Frame: On an average 1 week pre surgery and three months post surgery]

Quality of life [Time Frame: 3 and 12 months post surgery]

Physiology of the anal sphincter [Time Frame: 3 and 12 months post surgery]

Maximal oxygen uptake (VO2max) [Time Frame: On an average 1 week pre surgery]

Secondary ID(s)

2014/2284

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Olavs Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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