FITstrong: The feasibility of an exercise program for children who survived cancer

ISRCTN	ISRCTN08454156
DOI	https://doi.org/10.1186/ISRCTN08454156
Secondary identifying numbers	N/A

Submission date: 05/09/2007
Registration date: 05/09/2007
Last edited: 10/06/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr T. Takken
Scientific

University Medical Centre Utrecht (UMCU)/WKZ
KB.02.056.0
Lundlaan 6
Utrecht
3584EA
Netherlands

Phone	+31 (0)30 250 4030
Email	t.takken@umcutrecht.nl

Study information

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
Study setting(s)	Not specified
Study type	Quality of life
Scientific title	The feasibility of an exercise program for children who survived cancer: the FITStrong study
Study acronym	FITstrong
Study objectives	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(s)	Ethics approval received from University Medical Center Utrecht (The Netherlands) on the 2nd April 2007 (ref: 06/303).
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2007
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	15
Total final enrolment	16
Key inclusion criteria	1. 6 - 18 years of age 2. Between 0.5 and 1.5 years since final chemotherapy
Key exclusion criteria	Severe cardiomyopathy.
Date of first enrolment	01/05/2007
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Utrecht (UMCU)/WKZ

Utrecht
3584EA
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre

Wilhelmina Children's Hospital (WKZ)
Department Pediatric Fysiotherapy
Lundlaan 6
Amsterdam
3584 EA
Netherlands

Phone	+31 (0)30 250 4030
Email	p.j.m.helders@umcutrecht.nl
Website	http://www.umcutrecht.nl/zorg/
"ROR"	https://ror.org/04pp8hn57

Funders

Funder type

University/education

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

No information available

RoPaRun Foundation (Stichting RoPaRun) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/04/2009	10/06/2021	Yes	No

Editorial Notes

10/06/2021: Publication reference and total final enrolment added.