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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list