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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02403024 |
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Date of registration:
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24/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Feasibility and Efficacy of Interval Walking in Patients With Colorectal Cancer
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Scientific title:
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I-Walk-CRC - Feasibility and Efficacy of Interval Walking in Patients With Colorectal Cancer |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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39 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02403024 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Jesper F Christensen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a verified stage I-III CRC diagnosis who has
- All surgical and oncological treatments must be terminated
Exclusion Criteria:
- Any major surgical procedure planned within 6 months after inclusion
- Pregnancy
- Ongoing treatment for any known current malignancy
- Performance status > 1
- Inability to read and understand Danish
- Physically active for more than 150 minutes (moderate intensity) per week thus
adhering to the current recommendations
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Behavioral: InterWalk
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Behavioral: Waiting list control
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Primary Outcome(s)
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Change in VO2peak
[Time Frame: Baseline to week 12]
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Secondary Outcome(s)
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Change in Body composition
[Time Frame: Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24]
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Change in VO2peak (secondary comparisons)
[Time Frame: baseline-to-week24, week 12-to-week 24]
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Changes in bloodbiochemistry from fasting blood samples
[Time Frame: Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24]
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Changes in insulin sensityvity by measure of Oral Glucose Tolerance Test (OGTT)
[Time Frame: Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24]
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Changes in patient-reported Quality of Life
[Time Frame: Baseline-to-week 12; baseline-to-week 24; week 12-to-week 24]
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Secondary ID(s)
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I-Walk-CRC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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