Physical Activity and Health of Children With Cancer in Remission

NCT ID: NCT00839904

Last Updated: 2013-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Children Cancer Exercise

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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exercise

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

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

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

control

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Israel Cancer Association

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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gal dubnov raz

Senior physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GDR2-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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