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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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19 February 2015 |
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Main ID: |
NCT00111865 |
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Date of registration:
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26/05/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Healthy Exercise for Lymphoma Patients (HELP)
HELP |
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Scientific title:
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Randomized Controlled Trial of Exercise in Lymphoma Patients |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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122 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00111865 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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Contacts
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Name:
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Kerry S Courneya, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Non-hodgkin's lymphoma (including chronic lymphocytic leukemia) or Hodgkin's disease
- Approval of the treating oncologist
- Scheduled to receive no chemotherapy or chemotherapy for at least 8 weeks
- Able to understand and provide written informed consent in English
- 18+ years of age
- No uncontrolled hypertension, cardiac illness, psychiatric condition
- No contraindication to exercise as determined by a fitness test
Exclusion Criteria:
- Pregnant.
- Transplant candidate.
- Unwilling to accept randomization.
- Any medical condition that would be a contraindication to exercise. The clinicians
will make this decision.
- Unwilling to travel to/participate in the exercise program as defined by the
protocol.
- Planned/known absence of greater than 2 weeks during the intended study period
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphoma
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Intervention(s)
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Behavioral: Aerobic Exercise Training
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Primary Outcome(s)
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Change in QoL between baseline and postintervention.
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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treatment completion rates
[Time Frame: 12 weeks]
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Changes in cardiopulmonary fitness
[Time Frame: 12 weeks]
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psychosocial outcomes
[Time Frame: 12 weeks]
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body composition
[Time Frame: 12 weeks]
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Secondary ID(s)
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04 Courneya
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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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