NCT00839904

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

2.5 years

First QC Date

February 8, 2009

Last Update Submit

July 29, 2013

Conditions

Keywords

childrencancerexercisefitnessbody composition

Outcome Measures

Primary Outcomes (5)

  • health-related quality of life

    6months

  • mood

    6months

  • cardiorespiratory fitness

    6months

  • body fat percentage

    6months

  • bone mineral density

    6months

Study Arms (2)

exercise

EXPERIMENTAL

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

Behavioral: exercise

control

NO INTERVENTION

no intervention

Interventions

exerciseBEHAVIORAL

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

exercise

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged 6-16
  • remission from cancer
  • \>6 months after completion of all therapy

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior physician

Study Record Dates

First Submitted

February 8, 2009

First Posted

February 10, 2009

Study Start

February 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 30, 2013

Record last verified: 2013-07