Physical Activity and Health of Children With Cancer in Remission

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839904
• Other study ID #: GDR2-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: February 8, 2009
• Last updated: July 29, 2013
• Start date: February 2010
• Est. completion date: August 2012

Study information

• Verified date: July 2013
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Children
• Exercise

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Israel Cancer Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health-related quality of life		6months	No
Primary	mood		6months	No
Primary	cardiorespiratory fitness		6months	No
Primary	body fat percentage		6months	No
Primary	bone mineral density		6months	No