Condition category
Nervous System Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
07/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.netchild.nl

Contact information

Type

Scientific

Primary contact

Dr Olaf Verschuren

ORCID ID

Contact details

Revalidatiecentrum De Hoogstraat
Rembrandtkade 10
Utrecht
3583 TM
Netherlands
+31 (0)30 2561211
o.verschuren@dehoogstraat.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05-092

Study information

Scientific title

Acronym

FITPRO-CP

Study hypothesis

Children with cerebral palsy will benefit from functional fitness training.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, single blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cerebral parese (cerebral palsy)

Intervention

Fitness programme that consists of functional exercises. 45 minutes fitness training twice a week for 8 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Aerobic capacity.

Secondary outcome measures

1. Activities of daily life
2. Participation
3. Competence
4. Quality of life

Overall trial start date

15/10/2005

Overall trial end date

15/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Cerebral palsy
2. Gross Motor Function Classification System (GMFCS) I or II
3. Age 7 - 20 years
4. Informed consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

100

Participant exclusion criteria

1. Cardiac or respiratory conditions that may be affected by exercise
2. Surgical or orthopaedic procedures during or up to three months prior to the study

Recruitment start date

15/10/2005

Recruitment end date

15/06/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Revalidatiecentrum De Hoogstraat
Utrecht
3583 TM
Netherlands

Sponsor information

Organisation

University Medical Center Utrecht (The Netherlands)

Sponsor details

WKZ
Department of Pediatric Physiotherapy
Lundlaan 6
Amsterdam
3584 EA
Netherlands
+31 (0)30 2504030
p.j.m.helders@umcutrecht.nl

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Charity

Funder name

Dr WM Phelps-Stichting Voor Spastici (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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17984410

Publication citations

  1. Results

    Verschuren O, Ketelaar M, Gorter JW, Helders PJ, Uiterwaal CS, Takken T, Exercise training program in children and adolescents with cerebral palsy: a randomized controlled trial., Arch Pediatr Adolesc Med, 2007, 161, 11, 1075-1081, doi: 10.1001/archpedi.161.11.1075.

Additional files

Editorial Notes