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Clinical Trials/NCT00839904
NCT00839904CompletedNot Applicable

The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission

Hadassah Medical Organization0 sites22 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Primary Endpoint
health-related quality of life

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 16 Years (Child)
Sex
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)

Arms & Interventions

exercise

Experimental

two supervised, 60-minute weekly exercise sessions + instructions to perform additional physical activities throughout the day

Intervention: exercise (Behavioral)

control

No Intervention

no intervention

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

gal dubnov raz

Senior physician

Sheba Medical Center

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