Effectiveness and feasibility of intensive short-term graded exercise programmes

ISRCTN	ISRCTN81214142
DOI	https://doi.org/10.1186/ISRCTN81214142
Protocol serial number	6817
Sponsor	Sussex NHS Research Consortium (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme

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

Chailey Heritage Clinical Services
Research Department
Beggars Wood Road
North Chailey
Lewes
BN8 4JN
United Kingdom

Email	terry.pountney@southdowns.nhs.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised interventional process of care trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Gross Motor Function Measure-66, 88D and 88E 2. Kidscreen 27 (quality of life measure)
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/08/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Chailey Heritage Clinical Services

Lewes
BN8 4JN
United Kingdom

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	results	01/02/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes