Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001926224
Ethics application status
Approved
Date submitted
20/11/2018
Date registered
28/11/2018
Date last updated
22/11/2019
Date data sharing statement initially provided
28/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can aquatic physiotherapy improve aerobic capacity in adolescents with cerebral palsy?
Scientific title
A pilot randomised controlled trial: Can a water based exercise program improve aerobic capacity in adolescents with cerebral palsy
Secondary ID [1] 289243 0
nil known
Universal Trial Number (UTN)
Trial acronym
CPHydro
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 298816 0
Pain 302807 0
Cardiometabolic health 310527 0
Condition category
Condition code
Neurological 298870 298870 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 309237 309237 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 10 week aquatic training program performed in a dedicated paediatric tertiary hospital hydrotherapy pool at Perth Children's Hospital (PCH). The program is based on high intensity interval training. The properties of water will add resistance to fast paced movement providing simultaneous aerobic and strength training. Participants will participate in a supervised group setting. This program will be offered 3 days/week with participants expected to attend 2 days/week for 10 weeks duration. Adherence to the program will be monitored through the weekly attendance sheets where participants will be asked to report any additional exercise.

The program to improve aerobic capacity and muscle mass will follow previously published parameters utilised in land based exercise training. The 40 - 50 min class will include a warm up; High Intensity Interval Training (HIIT); a cool down and stretches.

During the HIIT phase, participants will exercise at two different intensities. Participants will have an individualised heart rate (HR) goal set by their HR at peak uptake of oxygen (VO2 peak) recorded during a maximal cycle cardiopulmonary exercise test. High intensity will be defined as between 80-95% of VO2 peak HR. Rest is defined as minimal activity. Rate of perceived exertion (RPE) will be recorded. HR will be continuously monitored through a water resistant heart rate device which will be paired to an external monitoring device. Intervals of 60 seconds high intensity activity will be followed by rest of a similar time duration and will be repeated 10 times. Participants will rotate through a circuit of activities each interval. These will be individually adapted to enable the participant to participate within their movement capabilities. Activities include water running, jumping, lower limb kicking and upper limb weights under water.
Intervention code [1] 294782 0
Treatment: Other
Comparator / control treatment
Following assessment and randomisation, the control group will be asked to continue with their same care and normal activities of daily living without advice or interaction from the research team. Following a 10 week period, they will be reassessed. Changes in exercise routines during this time will be reported. The control group will be offered exercise prescription advice after the study based on their individual results and the opportunity to participate in an aquatic physiotherapy class post final assessment to assist in exercise knowledge.
Control group
Active

Outcomes
Primary outcome [1] 301711 0
Variables related to feasibility of progressing this protocol to a large scale RCT will be reported. Specifically data will be reported relating to:
Recruitment fraction: of those who were invited to participate, the percentage who agreed to participate
Completion of baseline (pre-intervention) assessment: Of those who agreed to participate, the percentage who completed all baseline assessments
Adherence fraction to intervention: Of those randomised to intervention, the number who attended and participated in their nominated classes
Training intensity (in the intervention group only): The percentage who reached their target heart rate during the high intensity intervals, expressed as a percentage of the total number of high intensity intervals completed during the classes
Completion fraction: Of those who agreed to participate, the percentage who completed all aspects of the study
Timepoint [1] 301711 0
After the completion of assessments post intervention.
Secondary outcome [1] 333653 0
Peak rate of oxygen uptake measured during a CPET, undertaken on an electronically braked cycle ergometer. Secondary outcome measures will not be used to evaluate the effectiveness of the intervention, but the feasibility in collecting these measures.
Timepoint [1] 333653 0
Baseline and re assessment after 10 weeks intervention
Secondary outcome [2] 333654 0
Lean muscle mass, measured using Dual Energy X-ray Absorptiometry (DXA).
Timepoint [2] 333654 0
Baseline and re assessment after 10 weeks intervention
Secondary outcome [3] 333655 0
Pain measured using the Modified Brief Pain Inventory
Timepoint [3] 333655 0
Baseline and re assessment after 10 weeks intervention
Secondary outcome [4] 354240 0
Pain, activity participation and social interaction measured using the Canadian Occupational Performance Measure (COPM)
Timepoint [4] 354240 0
Baseline and re assessment after 10 weeks intervention
Secondary outcome [5] 354241 0
Pain, activity participation and social interaction measured using PedsQL TM
Timepoint [5] 354241 0
Baseline and re assessment after 10 weeks intervention

Eligibility
Key inclusion criteria
(i) a diagnosis of CP and classification as GMFCS Level II,
(ii) aged 12-17 years,
(iii) born at not less than 28 weeks gestation and discharged from hospital without an oxygen requirement,
(iv) have no absolute or relative contraindications to a cardiopulmonary exercise testing
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) concomitant medical conditions that limit exercise performance or preclude participation in a high intensity exercise program (e.g. unstable seizures),
(ii) participation in any intervention that may decrease the capacity to exercise during the study period (e.g. orthopaedic surgery)
(iii) unsuited to the hydrotherapy pool (e.g. open wounds, skin infections).

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)
Allocation will be concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be determined using a computer based random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, no inferential statistics will be conducted. The results of the study will be reported using descriptive statistics such as means and standard deviations (parametric data) or medians and interquartile ranges (non-parametric or ordinal data). Categorical data will be reported as frequencies and proportions. A sample size was determined to result in an acceptable level of precision around the point estimate for two outcomes related to feasibility (recruitment fraction and completion fraction). Specifically, it was estimated that a recruitment fraction for this study would be equal to 90% for this protocol to be feasible, without amendment, as a large scale definitive RCT. A sample size of 20 will produce an 80% CI around this estimate that spans from 81% to 99%. Similarly, it was estimated that the completion fraction for this study would be 75% for this protocol to be feasible, without amendment, as a large scale definitive RCT. A sample size of 20 will produce an 80% CI around this estimate that spans from 63% to 87%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/03/2019
Actual
4/04/2019
Date of last participant enrolment
Anticipated
30/04/2019
Actual
29/04/2019
Date of last data collection
Anticipated
4/08/2019
Actual
4/08/2019
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7815 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 15748 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 296154 0
Charities/Societies/Foundations
Name [1] 296154 0
Perth Children's Hospital Foundation
Country [1] 296154 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
Hospital Avenue, Nedlands, 6009. Perth WA
Country
Australia
Secondary sponsor category [1] 295447 0
None
Name [1] 295447 0
Address [1] 295447 0
Country [1] 295447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297400 0
Perth Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 297400 0
Ethics committee country [1] 297400 0
Australia
Date submitted for ethics approval [1] 297400 0
19/05/2016
Approval date [1] 297400 0
23/08/2016
Ethics approval number [1] 297400 0
2016048EP
Ethics committee name [2] 297401 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 297401 0
Ethics committee country [2] 297401 0
Australia
Date submitted for ethics approval [2] 297401 0
14/03/2017
Approval date [2] 297401 0
18/05/2017
Ethics approval number [2] 297401 0
HRE2017-0282

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

Contacts
Principal investigator
Name 65942 0
Ms Julie Depiazzi
Address 65942 0
Physiotherapy Department
Perth Children's Hospital
Hospital Avenue
Nedlands, Perth WA
6009
Country 65942 0
Australia
Phone 65942 0
+61 412019018
Fax 65942 0
Email 65942 0
[email protected]
Contact person for public queries
Name 65943 0
Julie Depiazzi
Address 65943 0
Physiotherapy Department
Perth Children's Hospital
Hospital Avenue
Nedlands, Perth WA
6009
Country 65943 0
Australia
Phone 65943 0
+61 412019018
Fax 65943 0
Email 65943 0
[email protected]
Contact person for scientific queries
Name 65944 0
Julie Depiazzi
Address 65944 0
Physiotherapy Department
Perth Children's Hospital
Hospital Avenue
Nedlands, Perth WA
6009
Country 65944 0
Australia
Phone 65944 0
+61 412019018
Fax 65944 0
Email 65944 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 2 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator


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
No additional documents have been identified.