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
Scientific
University Medical Centre Utrecht (UMCU)/WKZ
KB.02.056.0
Lundlaan 6
Utrecht
3584EA
Netherlands
| Phone | +31 (0)30 250 4030 |
|---|---|
| t.takken@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A 12 week aerobic and muscle strength training program (twice a week) compared with baseline training level |
| Secondary study design | Non randomised controlled trial |
| 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(s) |
Feasibility of the program. |
| Key secondary outcome measure(s) |
1. Peak oxygen uptake (VO2peak) |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
3584EA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.