Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001217695
Ethics application status
Approved
Date submitted
11/11/2014
Date registered
19/11/2014
Date last updated
1/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of strength training combined with functional skills training on muscle structure and function in young adults with cerebral palsy.
Scientific title
A randomised controlled trial of the efficacy of combined functional anaerobic and strength training on muscle properties and mechanical gait deficiencies in adolescents and young adults with spastic type Cerebral Palsy.
Secondary ID [1] 284775 0
Nil known.
Universal Trial Number (UTN)
U1111-1157-9252
Trial acronym
FAST CP.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 292550 0
Condition category
Condition code
Neurological 292856 292856 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 293804 293804 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will undertake 75 minutes of combined heavy progressive resistance training (PRT) and functional anaerobic training at a tertiary gymnasium, 3 times per week for 12 weeks, targeting the Gastrocnemii, Soleus, and Tibialis Anterior muscles. The heavy PRT will be performed first in each session and consist of 5 resistance exercises targeting the Gastrocnemii, Soleus, and Tibialis Anterior muscles. The PRT program will be periodised, comprising 3-4 sets of 6-12 repetitions of each exercise. Target intensity for the PRT component will be 60% 12 Repetition Maximum (12RM) in weeks 1-2; 80% 12RM in weeks 3-4; 100% 10RM in weeks 5-6; 100% 8RM in weeks 7-8, and 100% 6RM in weeks 9-12. 2-3 functional anaerobic exercises will be performed following the heavy PRT component of each session. These exercises will be performed at maximal intensity, comprising multiple all-out efforts lasting between 20s and 30s. Examples of the anaerobic exercises to be performed include step-ups, 5-metre shuttle runs, stair climbing, cornering, jumping, and agility shuttle runs. Correct technique will be strictly monitored at all exercise stations and individual feedback, instruction and demonstration will be provided by tertiary qualified exercise trainers. Each participant will complete a training diary in conjunction with the trainer throughout the intervention duration to document their progress, report injuries and fatigue levels, and provide intrinsic motivation to progress their training intensity. Participants will train in small groups up to a maximum of 6 people per training session.
Intervention code [1] 289872 0
Rehabilitation
Comparator / control treatment
The control group will continue usual care during the 12 weeks between baseline assessment and post-intervention testing. Participants allocated to the control group will not be allowed to partake in any progressive resistance training, however they may continue with their usual recreation.
Control group
Active

Outcomes
Primary outcome [1] 292731 0
Gastrocnemii, Soleus (SOL), and Tibialis Anterior (TA) muscle volume as assessed by Magnetic Resonance Imaging (MRI)
Timepoint [1] 292731 0
All outcome measures will be taken at baseline (pre-training), immediately following training (12 weeks), and 12 weeks following the cessation of training (24 weeks).
Primary outcome [2] 292732 0
Neuromechanical properties of the Medial Gastrocnemius (MG) muscle:
Passive and active mechanical properties of the MG muscle will be assessed using 2-dimensional B-mode ultrasound and a Biodex isokinetic dynamometer. Neural properties of the MG muscle will be measured using EMG data recorded from surface electrodes placed over the muscle bellies of the MG, Lateral Gastrocnemius (LG), SOL and TA. The level of voluntary activation of the MG muscle will be assessed using the interpolated twitch technique.


Timepoint [2] 292732 0
All outcome measures will be taken at baseline (pre-training), immediately following training (12 weeks), and 12 weeks following the cessation of training (24 weeks).
Secondary outcome [1] 309564 0
Isometric muscle strength:
The isometric muscle strength of the plantarflexor and dorsiflexor muscles will be measured with a Biodex isokinetic dynamometer.
Timepoint [1] 309564 0
All outcome measures will be taken at baseline (pre-training), immediately following training (12 weeks), and 12 weeks following the cessation of training (24 weeks).
Secondary outcome [2] 309565 0
Anaerobic power:
Assessed using the Muscle Power Sprint Test. Participants will be required to complete six 15m runs as quickly as possible with 10s rest between sprints.
Timepoint [2] 309565 0
All outcome measures will be taken at baseline (pre-training), immediately following training (12 weeks), and 12 weeks following the cessation of training (24 weeks).
Secondary outcome [3] 309566 0
Agility:
Assessed using the 10 x 5m Sprint Test. Participants will be asked to perform 10 five metre sprints continuously between two sets of cones on an indoor, non-slippery surface.
Timepoint [3] 309566 0
All outcome measures will be taken at baseline (pre-training), immediately following training (12 weeks), and 12 weeks following the cessation of training (24 weeks).
Secondary outcome [4] 309567 0
Functional strength:
A 30s repetition maximum (RM) test will be used as a functional strength assessment involving components of balance, speed, endurance and muscular strength. Participants will complete as many repetitions as possible in 30s of the following exercises: (1) lateral step up (performed unilaterally), (2) sit to stand (performed bilaterally), and (3) stand from half kneel (performed unilaterally).
Timepoint [4] 309567 0
All outcome measures will be taken at baseline (pre-training), immediately following training (12 weeks), and 12 weeks following the cessation of training (24 weeks).
Secondary outcome [5] 309568 0
Walking ability:
Assessed using the Six minute walk test; a timed up and down stairs test; and 3-Dimensional kinematics and kinetics from treadmill walking.
Timepoint [5] 309568 0
All outcome measures will be taken at baseline (pre-training), immediately following training (12 weeks), and 12 weeks following the cessation of training (24 weeks).
Secondary outcome [6] 309569 0
In vivo muscle mechanics during walking:
Medial gastrocnemius muscle fascicle behaviour during treadmill walking assessed using 2D B-mode ultrasound.
Timepoint [6] 309569 0
All outcome measures will be taken at baseline (pre-training), immediately following training (12 weeks), and 12 weeks following the cessation of training (24 weeks).
Secondary outcome [7] 309570 0
Participation:
The Assessment of Life Habits 3.0 Questionnaire will be used to assess an individual’s perception of participation related to daily activities and social roles. Six domains will be evaluated in this study including fitness, mobility, recreation, community life, and education and employment.
Timepoint [7] 309570 0
All outcome measures will be taken at baseline (pre-training), immediately following training (12 weeks), and 12 weeks following the cessation of training (24 weeks).

Eligibility
Key inclusion criteria
a) Aged between 15 and 30 years
b) Have a confirmed diagnosis of spastic hemiplegia or diplegia type CP
c) Can walk independently
d) Are Gross Motor Function Classification System (GMFCS) levels I or II
e) Who have maximum passive ankle dorsiflexion range of motion of <5 degrees (knee fully extended).
Minimum age
15 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Have had previous lower limb surgery in the last 2 years and/or Botulinum toxin-A injections to the lower extremities within the last 6 months
b) Cannot provide sufficient cooperation and cognitive understanding to participate in the intervention exercises
c) Have undertaken lower limb resistance training within the last 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed matched-pairs randomisation method. Participants will be matched in pairs according to age and sex, to minimise group differences at baseline, then randomised within pairs to the treatment or control group. Treatment allocation will be recorded by non-study personnel on a folded piece of paper and placed into sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated sequence of random numbers will be used to allocate a number “1” or “2” to each member of the pair. As each pair is randomised, they will be allocated the next consecutive envelope opened by non-study personnel until all participants have been allocated into the intervention or control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size for the overall trial is based on the study’s primary hypothesis comparison between the effects of function anaerobic and strength training to usual care immediately post-intervention (12 weeks) on muscle volume assessed. As there are no RCTs that have measured muscle volume as an outcome following resistance training in young adults with CP, we based our sample size off prospective cohort data with an observed effect size of d=0.49 reported for MG muscle volume change after lower limb strength training in children with CP, with a power of 0.80 and an alpha of 0.05. To allow for an estimated 20% dropout rate during the intervention, 34 participants will need to be recruited.

Group differences at baseline will be evaluated using the Student’s t-test for continuous data and Chi-square tests for dichotomous and ordinal data. Non-parametric tests (e.g. Mann-Whitney U test) will be used for data that is not normally distributed. Generalised estimating equations (GEE) for longitudinal analysis will be used to evaluate differences in continuous data between groups for the two post-baseline assessments on an intention-to-treat basis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/01/2015
Actual
23/01/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
28/12/2016
Date of last data collection
Anticipated
30/09/2017
Actual
12/04/2017
Sample size
Target
34
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4064 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 8871 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 290191 0
Government body
Name [1] 290191 0
National Health and Medical Research Council (NHMRC) Postgraduate Scholarship
Country [1] 290191 0
Australia
Funding source category [2] 290192 0
Charities/Societies/Foundations
Name [2] 290192 0
Australian Rotary Health Postgraduate Top-up Scholarship
Country [2] 290192 0
Australia
Primary sponsor type
University
Name
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland
Address
Level 7, Block 6, Royal Brisbane and Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 288902 0
University
Name [1] 288902 0
The University of Queensland
Address [1] 288902 0
School of Human Movement Studies
Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country [1] 288902 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291903 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 291903 0
Ethics committee country [1] 291903 0
Australia
Date submitted for ethics approval [1] 291903 0
Approval date [1] 291903 0
28/02/2014
Ethics approval number [1] 291903 0
2014000066
Ethics committee name [2] 295430 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [2] 295430 0
Ethics committee country [2] 295430 0
Australia
Date submitted for ethics approval [2] 295430 0
02/03/2015
Approval date [2] 295430 0
22/04/2015
Ethics approval number [2] 295430 0
HREC/15/QRCH/30
Ethics committee name [3] 297998 0
CPL Human Research Ethics Committee
Ethics committee address [3] 297998 0
Ethics committee country [3] 297998 0
Australia
Date submitted for ethics approval [3] 297998 0
14/06/2016
Approval date [3] 297998 0
14/07/2016
Ethics approval number [3] 297998 0
CPL-2016-001

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49118 0
Mr Jarred Gillett
Address 49118 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 6, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Country 49118 0
Australia
Phone 49118 0
+61418554853
Fax 49118 0
Email 49118 0
[email protected]
Contact person for public queries
Name 49119 0
Jarred Gillett
Address 49119 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 6, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Country 49119 0
Australia
Phone 49119 0
+61418554853
Fax 49119 0
Email 49119 0
[email protected]
Contact person for scientific queries
Name 49120 0
Jarred Gillett
Address 49120 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 6, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Country 49120 0
Australia
Phone 49120 0
+61418554853
Fax 49120 0
Email 49120 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFAST CP: Protocol of a randomised controlled trial of the efficacy of a 12-week combined Functional Anaerobic and Strength Training programme on muscle properties and mechanical gait deficiencies in adolescents and young adults with spastic-type cerebral palsy.2015https://dx.doi.org/10.1136/bmjopen-2015-008059
EmbaseThe effect of combined functional anaerobic and strength training on treadmill gait kinematics and kinetics in ambulatory young adults with cerebral palsy.2019https://dx.doi.org/10.1016/j.gaitpost.2019.03.023
N.B. These documents automatically identified may not have been verified by the study sponsor.