Condition category
Cancer
Date applied
05/09/2007
Date assigned
05/09/2007
Last edited
04/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr T. Takken

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)/WKZ
KB.02.056.0
Lundlaan 6
Utrecht
3584EA
Netherlands
+31 (0)30 250 4030
t.takken@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The feasibility of an exercise program for children who survived cancer: the FITStrong study

Acronym

FITstrong

Study hypothesis

Exercise training is a feasible method to improve fitness (peak oxygen uptake), muscle strength and fatigue in children who survived cancer.

Feasibility will be studied according to the number of performed training sessions and a structured interview with patients and training about their opinion on the training program.

Ethics approval

Ethics approval received from University Medical Center Utrecht (The Netherlands) on the 2nd April 2007 (ref: 06/303).

Study design

A 12 week aerobic and muscle strength training program (twice a week) compared with baseline training level

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Exercise in children who survived cancer

Intervention

Two times a week exercise training (45 minutes) starting with warm up, followed by muscle strength components and aerobic components and ended with a cool down. The participants have to perform home exercise two times per week, and at increasing muscle strength/endurance.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Feasibility of the program.

Timepoints:
t=0: baseline
t=1: after 12 weeks of training
t=2: 12 weeks follow-up

Secondary outcome measures

1. Peak oxygen uptake (VO2peak)
2. Muscle strength

Timepoints:
t=0: baseline
t=1: after 12 weeks of training
t=2: 12 weeks follow-up

Overall trial start date

01/05/2007

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. 6 - 18 years of age
2. Between 0.5 and 1.5 years since final chemotherapy

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

15

Participant exclusion criteria

Severe cardiomyopathy.

Recruitment start date

01/05/2007

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)/WKZ
Utrecht
3584EA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

Wilhelmina Children's Hospital (WKZ)
Department Pediatric Fysiotherapy
Lundlaan 6
Amsterdam
3584 EA
Netherlands
+31 (0)30 250 4030
p.j.m.helders@umcutrecht.nl

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

University/education

Funder name

Scientific College of Physiotherapy (Wetenschappelijk College Fysiotherapie [WCF]) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

RoPaRun Foundation (Stichting RoPaRun) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes