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

ISRCTN ISRCTN08454156
DOI https://doi.org/10.1186/ISRCTN08454156
Protocol serial number N/A
Sponsor University Medical Centre Utrecht (UMCU) (The Netherlands)
Funders Scientific College of Physiotherapy (Wetenschappelijk College Fysiotherapie [WCF]) (The Netherlands), RoPaRun Foundation (Stichting RoPaRun) (The Netherlands)
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

Primary study designInterventional
Study designA 12 week aerobic and muscle strength training program (twice a week) compared with baseline training level
Secondary study designNon randomised controlled trial
Scientific titleThe feasibility of an exercise program for children who survived cancer: the FITStrong study
Study acronymFITstrong
Study objectivesExercise 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) studiedExercise in children who survived cancer
InterventionTwo 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 typeOther
Primary outcome measure(s)

Feasibility of the program.

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

Key secondary outcome measure(s)

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

Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Years
Upper age limit18 Years
SexAll
Target sample size at registration15
Total final enrolment16
Key inclusion criteria1. 6 - 18 years of age
2. Between 0.5 and 1.5 years since final chemotherapy
Key exclusion criteriaSevere cardiomyopathy.
Date of first enrolment01/05/2007
Date of final enrolment01/01/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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.