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

Tracking Information
First Received Date ^ICMJE	February 8, 2009
Last Updated Date	February 7, 2010
Start Date ^ICMJE	February 2010
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00839904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Physical Activity and Health of Children With Cancer in Remission
Official Title ^ICMJE	The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Children Cancer Exercise
Intervention ^ICMJE	Behavioral: exercise two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	March 2011
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	6 Years to 16 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00839904
Other Study ID Numbers ^ICMJE	GDR2-HMO-CTIL
Has Data Monitoring Committee	No
Responsible Party	Gal Dubnov-Raz MD, Hadassah Medical Organization
Study Sponsor ^ICMJE	Hadassah Medical Organization
Collaborators ^ICMJE	Israel Cancer Association
Investigators ^ICMJE	Not Provided
Information Provided By	Hadassah Medical Organization
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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