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Physical Activity and Health of Children With Cancer in Remission

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00839904
First Posted: February 10, 2009
Last Update Posted: July 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Israel Cancer Association
Information provided by (Responsible Party):
gal dubnov raz, Sheba Medical Center
February 8, 2009
February 10, 2009
July 30, 2013
February 2010
August 2012   (Final data collection date for primary outcome measure)
  • health-related quality of life [ Time Frame: 6months ]
  • mood [ Time Frame: 6months ]
  • cardiorespiratory fitness [ Time Frame: 6months ]
  • body fat percentage [ Time Frame: 6months ]
  • bone mineral density [ Time Frame: 6months ]
Same as current
Complete list of historical versions of study NCT00839904 on ClinicalTrials.gov Archive Site
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Physical Activity and Health of Children With Cancer in Remission
The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission
Physical activity is a well-known and powerful tool in medicine,having preventive, palliative, and curative properties. This has not been sufficiently examined in children in remission from cancer. In this study, children in remission from cancer will be divided into exercise and control groups. The interventional group will perform two supervised, 60-minute weekly exercise sessions. Outcome measures of the exercise intervention will be quality of life, mood, cardiorespiratory fitness, body composition and bone mineral density.
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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Children
  • Cancer
  • Exercise
Behavioral: exercise
two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day
  • Experimental: exercise
    two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day
    Intervention: Behavioral: exercise
  • No Intervention: control
    no intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 2012
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • children aged 6-16
  • remission from cancer
  • >6 months after completion of all therapy

Exclusion Criteria:

  • informed consent not given in writing
  • refusal of tests: blood, fitness, questionnaires or DEXA
  • locomotive handicaps
  • extreme fatigue, nausea, dyspnea
  • concurrent acute illness
  • recent (less than 3 months) hospitalization
  • documented (echocardiographic or nuclear medicine) decrease in cardiac function
  • abnormal blood tests: Hb < 10 gr/dl, neutropenia < 500/mm3, thrombocytopenia < 50,000/mm3
  • additional chronic health conditions unrelated to cancer (e.g. celiac disease, cerebral palsy, Down's syndrome)
Sexes Eligible for Study: All
6 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00839904
GDR2-HMO-CTIL
No
Not Provided
Not Provided
gal dubnov raz, Sheba Medical Center
Hadassah Medical Organization
Israel Cancer Association
Not Provided
Hadassah Medical Organization
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP