|- candidate number||2657|
|- NTR Number||NTR1017|
|- Date ISRCTN created||5-sep-2007|
|- date ISRCTN requested||31-aug-2007|
|- Date Registered NTR||9-jul-2007|
|- Secondary IDs|| |
|- Public Title||FITstrong: The feasibility of an exercise program for children who survived cancer|
|- Scientific Title||The feasibility of an exercise program for children who survived cancer: the 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 opioning about the trainign program|
|- Healt Condition(s) or Problem(s) studied||Cancer, Children, Exercise|
|- Inclusion criteria||1. 6-18 years of age;
2. Between 0,5 and 1,5 years since final chemotherapy|
|- Exclusion criteria||Severe cardiomyopathy|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-mei-2007|
|- planned closingdate||1-jan-2008|
|- Target number of participants||15|
|- Interventions||Two times 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 2 times per week, and at increasing muscle strength/endurance.
|- Primary outcome||Feasibility of the program|
|- Secondary outcome||1. VO2peak
2. Muscle strength|
|- Trial web site||none|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. T. Takken|
|- CONTACT for SCIENTIFIC QUERIES||Dr. T. Takken|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ), Department Pediatric Fysiotherapy|
(Source(s) of Monetary or Material Support)
|Wetenschappelijk College Fysiotherapie (WCF), Stichting ROPArun|
|- Brief summary||Background: Fatigue and impaired exercise tolerance are well documented symptoms in cancer survivors and have a detrimental effect on quality of life outcome. Recent findings in adult cancer treatment show beneficial effects of exercise training.
Objective of the study:
To determine the feasibility of an exercise program in childhood cancer survivors in the primary health care system
A 12 week aerobic & muscle strength training program (2x/week) will be evaluated with immediate exercise testing and evaluation of habitual activities after the training period and this will be compared with a base line level that has been measured at the start of the program.
Fifteen children between 6 -16 yrs of age with after successful treatment for childhood cancer.
Two times 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 2 times per week, and at increasing muscle strength/endurance.
Primary study parameters/outcome of the study:
Compliance and adherence during the program
Secondary study parameters/outcome of the study (if applicable):
Pre program and post program levels of exercise tolerance, muscle strength and habitual physical activity.
|- Main changes (audit trail)|
|- RECORD||9-jul-2007 - 24-sep-2007|