Effectiveness and feasibility of intensive short-term graded exercise programmes
| ISRCTN | ISRCTN81214142 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81214142 |
| Secondary identifying numbers | 6817 |
- Submission date
- 18/06/2010
- Registration date
- 18/06/2010
- Last edited
- 29/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Terry Pountney
Scientific
Scientific
Chailey Heritage Clinical Services
Research Department
Beggars Wood Road
North Chailey
Lewes
BN8 4JN
United Kingdom
| terry.pountney@southdowns.nhs.uk |
Study information
| Study design | Multicentre randomised interventional process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effectiveness and feasibility of intensive short-term graded exercise programmes, using either treadmill or static exercise bicycle for non-ambulant children and young people with cerebral palsy in improving functional motor ability and quality of life |
| Study acronym | STATbiTR |
| Study objectives | Effectiveness and feasibility of intensive short-term graded exercise programmes, using either treadmill or static exercise bicycle for non-ambulant children and young people with cerebral palsy in improving functional motor ability and quality of life. |
| Ethics approval(s) | Brighton West Research Ethics Committee approved on the 20th June 2008 (ref: 08/H1111/30) |
| Health condition(s) or problem(s) studied | Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics |
| Intervention | A mixed methodology comprising the following two sub-studies: 1. Parallel arm randomised controlled trial evaluating programme effectiveness 2. A focus group-based qualitative study evaluating programme acceptability and feasibility 1. Parallel arm randomised controlled trial: Primary outcome measure: Gross Motor Function Measure (GMFM)-88E Secondary outcome measures: GMFM-88D, GMFM-66, Kidscreen-52 Quality of Life Health Questionnaire for Children and Young People Outline of measures: The GMFM-88D and GMFM-88E measure functional activity in children with CP. It is a standardised measure for use in children between the ages of 5 months and 16 years old. The GMFM-66 is a shorter version of the GMFM-88 and provides facility to convert scores to an interval scale. However, it can be insensitive at low levels and hence both measures will be administered. KIDSCREEN-52 A quality of life questionnaire will be completed by each child before and after the study. This Health-Related Quality of Life Measure is one of the 4 questionnaires, highly evaluated in the Asqme report and has been shown to provide valid results for health status, functional limitations and well-being. Young people taking part in the focus groups are likely to use alternative and/or augmentative communication and this will require novel approaches to facilitate the groups and the use of pictures and models to aid discussion. The child's Speech & Language Therapist will be consulted regarding his/her form of communication. Advocates who know a child will be used to help children communicate if they wish. Eligible children/young people who consent to participate will be randomised to receive either: 1.1. Continuation of individuals standard physiotherapy programme (control arm). 1.2. 6 week intensive graded exercise programme using a static bicycle 1.3. 6 week intensive graded exercise programme using a treadmill Assessment of all outcome measures will be taken at baseline, immediately post-intervention, 6 and 12 weeks post-intervention, by a researcher blinded to the study arm allocations. All assessments and interventions will be carried out in physiotherapy departments at participating sites, to minimise costs and inconvenience to participants. |
| Intervention type | Other |
| Primary outcome measure | 1. Gross Motor Function Measure-66, 88D and 88E 2. Kidscreen 27 (quality of life measure) |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/10/2008 |
| Completion date | 31/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 36 |
| Key inclusion criteria | 1. Children and young people cerebral palsy at Gross Motor Function Classification System (GMFCS) levels IV and V as this is the population for which exercise to be used 2. Aged 8 to 17 years - 8 years as tall enough to use trike and 17 years as research is taking place largely in schools and this would be upper limit to complete the study 3. Ability to pedal on a static bicycle and take steps on the treadmill when given additional postural support 4. Ability to follow the instructions needed for different aspects of graded exercise |
| Key exclusion criteria | 1. History of fracture to legs - may be vulnerable to further fracture 2. Cardiovascular disease - risk of heart/respiratory problems |
| Date of first enrolment | 01/10/2008 |
| Date of final enrolment | 31/08/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Chailey Heritage Clinical Services
Lewes
BN8 4JN
United Kingdom
BN8 4JN
United Kingdom
Sponsor information
Sussex NHS Research Consortium (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Department
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
England
United Kingdom
| Website | http://www.sxrc.nhs.uk/ |
|---|
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme
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 | results | 01/02/2013 | Yes | No |
