Condition category
Nervous System Diseases
Date applied
19/03/2012
Date assigned
18/04/2012
Last edited
25/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cerebral palsy (CP) is a condition that affects a person's muscle control leading to problems with movement, posture and coordination. It is caused by abnormal brain development or damage to the brain either before birth or in early childhood. The severity of the condition and any associated ailments (such as problems with vision, hearing, learning, etc) depend on the extent and location of this damage. Although there is no change to the brain abnormality throughout a person's life, the implication to the way they move and function physically in day-to-day life will change as they develop and age. Therapies such as physiotherapy can help maximize a patient's physical abilities and help them become more independent. Traditionally the focus of therapies and research for people with CP has been on children. When they are school aged they tend to receive comprehensive health care and well structured physiotherapy, but when they turn about 16-18 years old they are discharged from paediatric services. Health care for adults with CP tends to be much less complete, and often doesn't include treatments like physiotherapy. It is common for patients with CP to have big declines in their physical ability in early adulthood. This can have negative impacts on their independence, social life, emotional health and overall well-being. We will all experience a decline in our physical function as we get older, but people with CP seem to experience this at a much younger age (in their 20's or 30's) than people without a disability. For these reasons we think that adolescence and early adulthood is a very important time for patients with CP. They should be taking steps to help manage their disability on their own and hopefully put off this physical decline. To accomplish this, the strategy we are proposing in this research study is to get young people with CP into their local gym to exercise. We will provide them with a combined aerobic and strength training programme and show them how to complete it. Then we will measure how it impacts their physical function and quality of life. The goal is to help reduce any physical declines or even improve physical function when compared to peers with CP who aren't taking part in the programme.

Who can participate?
To take part you need to have cerebral palsy, be between 16 and 25 years old, and live in Lothian or Fife, Scotland.

What does the study involve?
If you take part in the study you will be randomly assigned to either a group that will be taking part in an exercise program or a control group. If you are in the exercise group you will take part in an 18-week exercise training programme. The exercise programme will take place at your local community leisure centre and will include strength exercises as well as aerobic exercises. An experienced physiotherapist will introduce you to the programme showing you how to do the different exercises. The physiotherapist will return for about 3 or 4 other sessions throughout the 18 weeks to check in and adapt the exercises as needed. For the other sessions a fitness instructor from the leisure centre will be available to help you out. For the first 6 weeks you will be expected to attend 3 supervised sessions per week. During weeks 7-12 you will attend 2 supervised sessions per week and will be encouraged to complete 1 more session on your own per week. In the last 6 weeks (13-18) there is no set number of sessions but you will be encouraged to complete 3 sessions per week on your own. We will provide you with a logbook describing the different exercises and ask you to record what you are doing and any comments you have. If you are put in the control group you will not take part in the exercise programme. You'll just continue to do what you would normally be doing. At the end of the 18 weeks when the study is complete you will be given free leisure centre access for 6 months. Regardless of which group you are in, everyone who participates in the study will be asked to also come to Queen Margaret University four times to have your physical function tested. Each assessment will take about 2.5 to 3 hours to complete. These will be done at the beginning of the study, and after 6, 12, and 18 weeks. During the assessment a number of different measures will be recorded. You will complete some questionnaires and be asked to perform activities such as walking, standing from a seat, and going up stairs. Your muscle strength will be measured for a number of muscles in your legs. The flexibility of your ankle, knee and hip will be recorded. Your physical fitness will be tested by having you do a 10 m shuttle run/walk test which is designed specifically for people with CP. We will also do gait analysis. For this, reflective balls (called markers) will be stuck to your legs and hips and you will be asked to walk back and forth in the lab. The markers will allow us to analyse your movement patterns during walking. You will also be given a small (about the size of a matchbook) activity monitor that we will ask you to wear for one week. This will record information on how much you walk, sit and stand throughout a day.

What are the possible benefits and risks of participating?
By taking part in this study you will be given 6 months of free access to your local leisure centre and hopefully some motivation to use it to get/stay fit. There are also indirect benefits for other young adults with CP. This study will help to develop an exercise program to assist young adults in their transition from childhood to adult healthcare and hopefully help improve their quality of life. The assessment procedure involved is a safe and common clinical assessment. However, there exist minimal risks such as the possibility to fall, trip etc. There is a risk of injury during any fitness program. This will be minimized because the physiotherapist will work with you to make sure the exercises are appropriate and a fitness instructor will be available at the leisure centre to help you out and make sure you are doing the exercises properly.

Where is the study run from?
The study is being run at Queen Margaret University, Edinburgh, Scotland. We are working with Edinburgh Leisure, West Lothian Leisure, and East Lothian Leisure to provide you with a facility close to home where you can exercise.

When is the study starting and how long is it expected to run for?
The study is currently underway and we will continue to recruit participants until April 2016.

Who is funding the study?
The study is funded by two charities:
1. The James and Grace Anderson Trust
2. La Fondation Motrice

Who is the main contact?
Marietta van der Linden
mvanderlinden@qmu.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marietta van der Linden

ORCID ID

Contact details

Queen Margaret University
Physiotherapy Department
Queen Margaret University Drive
Musselburgh
East Lothian
EH21 6UU
United Kingdom
+44 (0)131 474 0000
mvanderlinden@qmu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effects of a pragmatic community-based exercise therapy intervention on physical fitness, habitual physical activity, self-esteem and quality of life on adolescents and young adults with cerebral palsy: a pilot study

Acronym

Study hypothesis

Patients who undergo a community-based individualized exercise therapy program will show improvements in muscle strength, function, and quality of life with respect to baseline measures as compared to peers who do not take part in the exercise program.

On 25/08/2015 the overall trial end date was changed from 31/12/2012 to 01/12/2016.

Ethics approval

1. Lothian NHS Board South East Scotland Research Ethics Committee, 09/03/2011, ref: 11/AL/0044
2. NHS Fife Operational division, 19/04/2011, ref: 11-015 NRA11/NE39 11/AL/0044

Study design

Prospective single-blind parallel-group randomized control trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cerebral palsy

Intervention

Participants will be randomized to either an exercise group or a control group.

Those in the exercise group will be asked to complete an 18-week exercise programme taking place at their local leisure centre. The programme will consist of a combination of aerobic, strength and flexibility exercises. The exercise program will involve three supervised sessions per week during weeks 1-6, two supervised sessions with encouragement to complete a third unsupervised session per week during weeks 7-12, and encouragement to complete three unsupervised sessions per week during weeks 13-28. The control group will continue with their usual activities. All participants will be assessed at baseline and at 6, 12 and 18 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The change in Gross Motor Function Measure (GMFM) for dimensions D and E from baseline to 6, 12 and 18 weeks.
The Gross Motor Function Measure was developed to assess children with cerebral palsy. It uses a 4-point scale to rate participants on their ability to complete a motor task.

Secondary outcome measures

1. Body function & structures
1.1. Aerobic fitness based on a 10 m shuttle run/walk
1.2. Maximal isometric muscle strength
1.3. Range of motion at the ankle, knee, and hip.
2. Activity
2.1. Timed up and go (TUG) test - time for a participant to rise from a chair, walk 3 m, return to the chair and sit down again
2.2. Gait Profile Score (GPS) - determined from computerized three-dimensional movement analysis
3. Participation
3.1. Daily physical activity level
3.2. Quality of life, and function in activities of daily living
3.3. Functional Assessment Questionnaire (FAQ)
3.4. Canadian Occupational Performance Measure (COPM)

Measures for the function & structures and activity components will be recorded during all four assessments (baseline and at 6, 12, 18 weeks) while outcomes for the participation component will only be measured twice (baseline and 12 weeks). A Rosenberg Self-Esteem Scale will also be completed, but only at baseline and after completion of the training program.

A small activity monitor (ActivPAL, PAL Technologies Limited, Glasgow, UK) attached to the front of the thigh will be used to assess the amount of physical activity the participants engage in over a 7-day period. The device will record the number of steps, sit-to-stand and stand-to-sit transitions and the time spent walking, standing, or sitting and lying. Quality of life for each participant will be measured using the Short Form 12, a self report survey. The third and forth outcome measures are a self-report survey (FAQ) and a scored patient interview (COPM) respectively, used to assess function during activities of daily living.

Overall trial start date

01/03/2011

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with spastic cerebral palsy
2. Aged 16 - 25 years
3. Living in Lothian or Fife
4. Discharged from the paediatric service within the last 6 years
5. Able to ambulate with or without aids

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Participating or participated in a gym based exercise training program within the last 2 months
2. Receiving regular physiotherapy (more often than 1 session every 4 weeks)
3. Insufficient cognitive ability to give informed consent
4. Medical issues with participating in an exercise program
5. Received Orthopaedic surgery or Botox injections within the last 6 months

Recruitment start date

01/03/2011

Recruitment end date

01/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Margaret University
East Lothian
EH21 6UU
United Kingdom

Sponsor information

Organisation

Queen Margaret University (UK)

Sponsor details

Queen Margaret University Drive
Musselburgh
East Lothian
EH21 6UU
United Kingdom

Sponsor type

University/education

Website

http://www.qmu.ac.uk/

Funders

Funder type

Charity

Funder name

The James and Grace Anderson Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

La Fondation Motrice (France)

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

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes