Physical Activity and Health of Children With Cancer in Remission

July 29, 2013 updated by: gal dubnov raz, Hadassah Medical Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
no intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
health-related quality of life
Time Frame: 6months
6months
mood
Time Frame: 6months
6months
cardiorespiratory fitness
Time Frame: 6months
6months
body fat percentage
Time Frame: 6months
6months
bone mineral density
Time Frame: 6months
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Israel Cancer Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 8, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GDR2-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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