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Physical Activity and Health of Children With Cancer in Remission

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Israel Cancer Association
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00839904
First received: February 8, 2009
Last updated: February 7, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention
Children
Cancer
Exercise
 Behavioral: exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • health-related quality of life [ Time Frame: 6months ] [ Designated as safety issue: No ]
  • mood [ Time Frame: 6months ] [ Designated as safety issue: No ]
  • cardiorespiratory fitness [ Time Frame: 6months ] [ Designated as safety issue: No ]
  • body fat percentage [ Time Frame: 6months ] [ Designated as safety issue: No ]
  • bone mineral density [ Time Frame: 6months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Gal Dubnov-Raz MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00839904     History of Changes
Other Study ID Numbers: GDR2-HMO-CTIL
Study First Received: February 8, 2009
Last Updated: February 7, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
children
cancer
exercise
fitness
body composition

ClinicalTrials.gov processed this record on May 16, 2013