Physical Activity and Health of Children With Cancer in Remission

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. Identifier: NCT00839904
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : July 30, 2013
Israel Cancer Association
Information provided by (Responsible Party):
gal dubnov raz, Sheba Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Children Cancer Exercise Behavioral: exercise Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission
Study Start Date : February 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: exercise
two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day
Behavioral: exercise
two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day

No Intervention: control
no intervention

Primary Outcome Measures :
  1. health-related quality of life [ Time Frame: 6months ]
  2. mood [ Time Frame: 6months ]
  3. cardiorespiratory fitness [ Time Frame: 6months ]
  4. body fat percentage [ Time Frame: 6months ]
  5. bone mineral density [ Time Frame: 6months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Responsible Party: gal dubnov raz, Senior physician, Sheba Medical Center Identifier: NCT00839904     History of Changes
Other Study ID Numbers: GDR2-HMO-CTIL
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by gal dubnov raz, Sheba Medical Center:
body composition