Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001293651p
Ethics application status
Submitted, not yet approved
Date submitted
16/11/2023
Date registered
12/12/2023
Date last updated
12/12/2023
Date data sharing statement initially provided
12/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of FitSkills for Young Adults with cerebral palsy who use wheeled mobility.
Scientific title
Feasibility of FitSkills for Young Adults with cerebral palsy who use wheeled mobility to access the community.
Secondary ID [1] 310855 0
2023-3251HC
Universal Trial Number (UTN)
U1111-1299-6095
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 331891 0
Functional decline 331892 0
mobility impairment 331893 0
Condition category
Condition code
Neurological 328622 328622 0 0
Other neurological disorders
Musculoskeletal 328915 328915 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12-week intervention program is designed for young adults aged 18 to 40 with cerebral palsy (CP) who utilise wheeled mobility devices. The intervention involves a screening process using the PAR-Q+ questionnaire to assess the participant's readiness for exercise. Medical clearance is sought if indicated by the screening results. Upon clearance, participants will be paired with student peer mentors studying nursing, occupational therapy, or health science at a regional University Campus in Warrnambool. These mentors will not be functioning as personal trainers or health specialists will exercise alongside the adults with CP, following a tailored exercise regime created by a physiotherapist.

The intervention consists of two 1-hour sessions per week for 12 weeks, incorporating progressive resistance and aerobic exercises. Intensity will be prescribed at a moderate intensity, and assessed using RPE for cardiovascular exercise and repetition range of 10 to 12 repetitions for progressive strength training. Exercise sessions will be monitored via PhysiTrack, an online exercise prescription, delivery and monitoring tool. Exercises may consist of an arm ergometer for upper limb cardiovascular training and pin loaded machines, bands and cables for progressive strength training, aiming for a repetition range of 10 - 12. Before participation, mentors undergo 2-3 hours of in-person training covering program content, manual handling, and strategies to motivate and support individuals with complex CP. Participants also meet with the principal investigator (PI) for customisation of exercise prescriptions aligned with their goals, preferences, and abilities. Safety instructions on equipment use will be provided in the first week provided, with the PI supervising the initial two gym sessions and conducting weekly check-ins with each exercising pair separately.

The intervention will operate within a local council community gym, The intervention PI will be supported by collaborations with physiotherapists and researchers specialising in CP from St Vincent's Hospital and Murdoch Children's Research Institute. Participants will receive a gym membership for the 12-week duration and undergo interviews using semi-structured schedules at the program's conclusion. Outcome measures include validated tools assessing participation, quality of life, and physical fitness data collected and analysed from program logs.

Acknowledging inherent risks in physical activity, the program mitigates these risks through thorough screening, medical clearance, and supervised sessions. Previous research has indicated the safety of gym-based exercise sessions for adults with CP utilising wheeled mobility devices.
Intervention code [1] 327272 0
Rehabilitation
Intervention code [2] 327273 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336609 0
Primary - Feasibility - Safety / Practicality, which will be assessed as a composite of primary outcome.
Timepoint [1] 336609 0
Safety data collected throughout 12-weeks of intervention
Primary outcome [2] 336610 0
Primary - Feasibility - Acceptability
Timepoint [2] 336610 0
Interviews will be completed 1-week post-intervention (12-weeks + 1-week).
Primary outcome [3] 336611 0
Primary - Feasibility - Adaption
Timepoint [3] 336611 0
Adaptation log data will be collected throughout 12-weeks of intervention.
Interviews will be completed 1-week post-intervention (12-weeks + 1-week).
Secondary outcome [1] 428964 0
Limited-efficacy Participation
Timepoint [1] 428964 0
Both outcome measures GAS and Y- PEM will be assessed at 0, 6, 12-weeks and follow-up at 24-weeks.
Secondary outcome [2] 429474 0
Limited-efficacy Quality of Life.
Timepoint [2] 429474 0
Quality of Life - PROMIS Scale will be assessed at 0, 6, 12-weeks and follow-up at 24-weeks.

Eligibility
Key inclusion criteria
Group 1: Adults with CP
1. Has cerebral palsy or other childhood onset neurodevelopmental disability.
2. Use wheeled mobility for long distances such as to access the community.
3. Can follow simple instructions delivered using their preferred method of communication (e.g., verbal, written or gestured).
4. Are able to provide their own consent (written, spoken, gestured).
5. Ability to participate in a moderate-to-high intensity exercise program as determined by the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+), and, if indicated by the screening tool , received clearance from a general practitioner to participate at the expense of the participant

Group 2: Student Peer Mentor
1. University student - any year level – from Deakin University School of Nursing, Occupational Therapy or Health Science.
2. Hold current police checks, or willing to obtain prior to commencement of study.
3. Not explicit inclusion criteria but preference for similar age and interests to adult with CP.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Group 1: Adults with CP
1. Have participated in a gym-based program within the past three months.
2. Have an unstable, or acute medical condition and have been deemed unsafe to participate by their doctor or health professional (i.e., epilepsy, cardiac condition).
3. Neurological conditions which are degenerative (i.e., muscular dystrophy).
4. A significant psychological or behavioural disorder that would impact their participation (e.g., resistive behaviour, severe depression, or severe anxiety) as reported by the participant or observed during recruitment and project onboarding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
There are several key components to the analysis of the data. As a first step, demographic data (age, gender, health, description of CP and associated impairments) will be described at the case level ensuring that no participant will be able to be identified.
Quantitative data will be collected and discussed at the individual level using descriptive statistics.
The qualitative data collected from interviews will be analysed using a qualitative description methodology.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
3/05/2024
Actual
Date of last data collection
Anticipated
11/10/2024
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 41694 0
3280 - Warrnambool
Recruitment postcode(s) [2] 41695 0
3280 - Dennington
Recruitment postcode(s) [3] 41696 0
3280 - Warrnambool East
Recruitment postcode(s) [4] 41697 0
3280 - Warrnambool West

Funding & Sponsors
Funding source category [1] 315112 0
Government body
Name [1] 315112 0
Department of Education:The Australian Government Research Training Program Scholarship (RTP)
Country [1] 315112 0
Australia
Funding source category [2] 315243 0
University
Name [2] 315243 0
Australian Catholic University Postgraduate Research Student Support Scheme (PRSSS)
Country [2] 315243 0
Australia
Funding source category [3] 315244 0
Government body
Name [3] 315244 0
NHMRC-funded Centre for Research Excellence CP-Achieve (GNT1171758).
Country [3] 315244 0
Australia
Primary sponsor type
Other
Name
NHMRC-funded Centre for Research Excellence CP-Achieve (GNT1171758).
Address
Murdoch Children's Research Institute, 50 Flemington Road, Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 317274 0
University
Name [1] 317274 0
Australian Catholic University Postgraduate Research Student Support Scheme (PRSSS)
Address [1] 317274 0
115 Victoria Parade Fitzroy, Melbourne
Country [1] 317274 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314050 0
Australian Catholic University's Human Research Ethics Committee (HREC)
Ethics committee address [1] 314050 0
Ethics committee country [1] 314050 0
Australia
Date submitted for ethics approval [1] 314050 0
10/10/2023
Approval date [1] 314050 0
Ethics approval number [1] 314050 0

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

Contacts
Principal investigator
Name 130238 0
Mr James Czencz
Address 130238 0
Australian Catholic University 115 Victoria Parade, Fitzroy VIC 3065
Country 130238 0
Australia
Phone 130238 0
+61 407632363
Fax 130238 0
Email 130238 0
[email protected]
Contact person for public queries
Name 130239 0
James Czencz
Address 130239 0
Australian Catholic University, 115 Victoria Parade, Fitzroy VIC 3065
Country 130239 0
Australia
Phone 130239 0
+61 407632363
Fax 130239 0
Email 130239 0
[email protected]
Contact person for scientific queries
Name 130240 0
James Czencz
Address 130240 0
Australian Catholic University, 115 Victoria Parade, Fitzroy VIC 3065
Country 130240 0
Australia
Phone 130240 0
+61 407632363
Fax 130240 0
Email 130240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not applicable for feasibility study, or interview data to protect participant identity.


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.