Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000766314
Ethics application status
Approved
Date submitted
17/05/2017
Date registered
24/05/2017
Date last updated
12/10/2022
Date data sharing statement initially provided
27/02/2020
Date results provided
12/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
FitSkills: a community-university partnership to increase exercise participation among youth with disability
Scientific title
FitSkills: a community-university partnership to increase exercise participation among youth with disability
Secondary ID [1] 291894 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disability 303185 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302627 302627 0 0
Physiotherapy
Musculoskeletal 302776 302776 0 0
Other muscular and skeletal disorders
Neurological 302777 302777 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an exercise program called FitSkills. The program matches a young person with disability with a mentor from their community and the pair exercise together at their local public gym (one-to-one), for an hour, twice a week for 12 weeks (24 sessions in total). The program comprises individually tailored exercise and plans for on-going participation in exercise.
The exercise content comprises weight and aerobic training, individually tailored to the young person with disability. The exercise program (including the intensity) will be prescribed by members of the research team according to international guidelines from the American College of Sports Medicine (ACSM). The exercise program will be planned with the young person with disability and their family through a telephone interview and incorporating details from their baseline assessment to help determine what their training goals are, their preferences for type of exercise and their impairment(s).

To assist participants to plan ongoing participation in exercise after FitSkills, they will be provided with a booklet with information about benefits of continuing to exercise, how they can participate in exercise and where they can participate in exercise. This booklet will be designed specifically for this study.

The mentor exercises with the young person with disability. The mentors will be students enrolled in Allied Health courses (any discipline, any year level) at two universities in Melbourne, Australia (La Trobe University and Australian Catholic University). Mentors are volunteers who are selected based on residential location and will hold a current police and working with children check. Mentors are matched with a young person with disability from the same locality. All mentors complete a 3-hour face-to-face group training session on program content and motivational strategies conducted at either the university campus or at the facilities of one of our partner organisations. The training will be delivered by a member of the research team. Mentors are provided with written materials that include information about disability, an outline of the exercise program and advice for how the program should be delivered.

As mentors may not have pre-existing knowledge of exercise training or disability, they will maintain fortnightly contact with a member of the research team to address issues that arise, and to ensure that the intervention is being carried our as per protocol (i.e. the team member will check that the program continues to be delivered according to the ACSM guidelines). To monitor intervention fidelity, participants and mentors will document their programs in an exercise logbook, including exercise type and dose, adverse events or missed sessions. The exercise logbooks will be collected at the end of the intervention and data about the program analysed by members of the research team (e.g. number of sessions attended or intensity progression for exercises performed). Analysis of the exercise logbook data will help identify any issues with intervention fidelity and this information will be used to maintain or improve fidelity at subsequent sites during roll-out of the program.
Intervention code [1] 298010 0
Rehabilitation
Intervention code [2] 298137 0
Lifestyle
Comparator / control treatment
The study design is a stepped wedge cohort design with 8 sites and 4 cluster groups. This design sequentially introduces the intervention to 8 gyms (sites) in random order. After an initial 3-month baseline period when no sites are exposed (control phase), at 3-month intervals sites are randomised to cross from control to intervention phase until all sites have implemented FitSkills. Each gym site represents a cluster unit. The trial design will comprise four cluster groups each containing two randomly allocated cluster units. One cluster group (2 sites) will commence the intervention every 3 months. A member of the research team who is not involved in recruitment, assessment or delivery of the intervention, will randomise the order of the 8 sites using web-based software.
Control group
Active

Outcomes
Primary outcome [1] 302034 0
Feasibility: will be measured: (1) using data from our partner organisations to map numbers of their constituents living close to FitSkills sites and comparing to the number of enrolments; (2) comparing numbers of enquiries with enrolments in FitSkills; (3) documenting wait-lists and mentor expressions of interest; (4) using data from exercise logbooks documenting attendance and involvement during FitSkills, intervention fidelity (including exercise intensity), and adverse events; (5) gaining perspectives of youth with disability, their families and mentors, and gym management and staff on FitSkills from semi-structured interviews; Data on the experience of youth with disability of the gym context will also be measured by the Self-reported Experiences of Activity Settings and Measure of Environmental Qualities of Activity Settings questionnaires; and (6) reviewing each site’s disability policy and procedures using National Information Communication Awareness Network (NICAN) guidelines.
Timepoint [1] 302034 0
(1) Mapping of the numbers of members from partner organisations living close to sites will occur prior to recruitment. These numbers will be and compared to the number of enrolments immediately before implementation of the intervention at each site.
(2) The number of enquiries will be compared with the numbers of enrolments in FitSkills immediately before implementation of the intervention at each site
(3) numbers of our wait-lists and mentor expressions of interest will be documented at 3-month intervals throughout the 2 year data collection period
(4) data from exercise logbooks documenting attendance, adherence (intervention fidelity) during FitSkills, and adverse events will be analysed at the end of each program.
(5) the perspectives of youth with disability, their families and mentors, and gym management and staff on FitSkills from semi-structured interviews will be collected immediately after the intervention. Questionnaires about the experience of youth with disability of the gym context will be measured immediately after the program also.
(6) a review of each site’s disability policy and procedures using National Information Communication Awareness Network (NICAN) guidelines will be performed prior to the implementation of FitSkills
Primary outcome [2] 302035 0
Participation has two essential components: attendance (being there) and involvement (experience of participation). Attendance (type, frequency) will be measured using Adolescent Physical Activity Recall, Adolescent Sedentary Activity and 16 physical activity items from Children’s Assessment of Participation and Enjoyment questionnaires.
Timepoint [2] 302035 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).
Primary outcome [3] 302187 0
Involvement (experience of participation) will be measured using youth self-report of the community section of the Participation and Environment Measure-Children and Youth.
Timepoint [3] 302187 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).
Secondary outcome [1] 334591 0
Health-related quality of life of the youth with disability will be measured using the 9-item Child Health Utility instrument. This is an additional primary outcome.
Timepoint [1] 334591 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).
Secondary outcome [2] 334592 0
Economic analysis (composite outcome), taking a societal perspective, will be completed. Data to inform the economic analysis will be collected from participants and their families on socioeconomic status (employment, income, carer requirement, leisure), attendance (time, travel, out-of-pocket expenses) and health service use if injured (hospital attendance, admission, consultations, investigations). Data will be collected from mentors to determine their participation (time, travel, out-of-pocket expenses). Mentor time will be costed at university rates. Annual cost of capital (equipment, space) at the sites will be costed according to the opportunity cost method. Reasonable rental equivalent will be used to cost space. Incremental cost effectiveness ratios (ICERs) expressed as cost per quality adjusted life years saved will be calculated comparing costs and health related quality of life outcomes between FitSkills and no intervention based on difference in costs and the health related quality of life utility index between the pre- and post-intervention periods.
Timepoint [2] 334592 0
Economic data will be collected from all youth with disability, their families and mentors before the intervention and for at least 6 months after the intervention.
Secondary outcome [3] 335129 0
Perception of wellbeing will be measured using the 20-item Life Satisfaction Scale.
Timepoint [3] 335129 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).
Secondary outcome [4] 335130 0
Physical activity will be measured as minutes spent doing moderate intensity activity with an activity monitor (Actigraph) worn for 8 consecutive days (one day familiarisation).
Timepoint [4] 335130 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).
Secondary outcome [5] 335131 0
Attitudes to exercise will be measured using the 9-item Exercise Outcomes Scale which assesses self-rated perceived benefits of exercise.
Timepoint [5] 335131 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).
Secondary outcome [6] 335132 0
Barriers to exercise will be assessed using the 18-item Exercise Barriers Scale which measures perceived motivational, knowledge, accessibility, cognitive and social barriers to exercise for people with disability.
Timepoint [6] 335132 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).
Secondary outcome [7] 335133 0
Exercise self-efficacy will be measured using the 5-item Self-Efficacy Measure which reports exercise performance self-efficacy pertaining to confidence in performing exercise.
Timepoint [7] 335133 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).
Secondary outcome [8] 335134 0
Walking capacity will be measured using the six-minute walk test using a modified technique that allows continuous encouragement.
Timepoint [8] 335134 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).
Secondary outcome [9] 335224 0
Attitudes to disability of student mentors will be measured using the 5-item Discomfort scale which indicates respondent’s level of discomfort when interacting with people with disability.
Timepoint [9] 335224 0
Measured every 3 months from participant enrolment in the trial until completion of the trial (24-months).

Eligibility
Key inclusion criteria
Youth with disability (including physical, intellectual, sensory disabilities) will be eligible for inclusion in the trial if: (1) they are 13-30 years, (2) can follow simple verbal instructions in English (as indicated by the Index of Social Competence) and (3) are medically fit to take part in a high intensity exercise program as determined by their responses to the Adult Pre-exercise Screening tool. If their responses to this questionnaire indicate a potential problem then they will be asked to get a medical clearance certificate to participate from their medical practitioner.
Minimum age
13 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they: (1) participated in a high-intensity exercise program within 3 months prior to the trial; (2) have an acute or concurrent medical condition rendering them unfit to take part (e.g. severe cardiac conditions, severe osteoarthritis, uncontrolled epilepsy); or (3) have a significant behavioural problem that would impact on participation (e.g. resistive behaviour or severe depression or severe anxiety).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Embedded in an implementation science framework, our stepped wedge cluster randomised trial, using a cohort design, will compare the effect of FitSkills with a control phase. This design sequentially introduces FitSkills to gymnasia (sites) in random order. After an initial period when no sites are exposed (control phase), at regular intervals sites are randomised to cross from control to intervention phase until all sites have implemented FitSkills
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative analyses will be conducted according to intention to treat analysis principles, unless otherwise specified. Continuous data and costs will be analysed using linear mixed effects models with random effects to account for correlation within individuals and for clustering within sites. A random slope effect will also be used for the treatment effect to allow for heterogeneity across clusters. Linear mixed effects models are the recommended approach to analysing stepped wedge cluster data. Ordinal data will be analysed using Generalized Estimating Equations accounting for correlation within sites. Analyses will be adjusted for relevant baseline measures, and seasonal effects will be considered. Sensitivity analysis for missing data will be carried out as per guidelines. Baseline characteristics associated with missingness will be included as covariates and the data modelled under the assumption of missing at random. Findings will be compared to results from other missing data strategies including multiple imputation and return-to-baseline. Bootstrapping will be used where costs show a skewed distribution.

The theoretical framework underpinning the qualitative data analysis is interpretive description. Audio-recorded participant interviews will be transcribed verbatim by a professional transcription service. Ideas that emerge in early interviews will be explored during later interviews to form a rich, nuanced understanding of the data. NVivo software (QSR International, Melbourne) will be used to manage the data analysis process. Analysis will commence with line-by-line coding of transcripts, by two researchers independently. After initial coding, the two researchers will meet to review the codes together. Inductive reasoning will be used to group the emergent codes into categories, subthemes and themes. Strategies to ensure credibility, transferability and dependability of the data will be used including triangulation of data with other sources (e.g. quantitative data, exercise logs) and using ‘rich thick description’, whereby direct verbatim quotations are included in reports. Coherent links between the data and reported findings will be established through member checking.

Economic analysis will take a societal perspective. Mentor time will be costed at university rates and participant time will be costed using Australian average adult wage. Annual cost of capital (equipment, space) at the sites will be costed according to the opportunity cost method. Reasonable rental equivalent will be used to cost space. Health services will be costed according to the actual service used from various sources including Commonwealth Medicare Benefits Schedule (http://www.mbsonline.gov.au), Independent Hospital Pricing Authority (https://www.ihpa.gov.au) and Transport Accident Commission for allied health services (http://www.tac.gov.au). Costs will be reported in 2019 AUD. Incremental cost effectiveness ratios (ICERs) expressed as cost per quality adjusted life years saved will be calculated comparing costs and health-related quality of life outcomes between FitSkills and no intervention based on difference in costs and health-related quality of life utility index between the pre- and post-intervention periods.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/10/2017
Actual
23/01/2018
Date of last participant enrolment
Anticipated
Actual
6/01/2019
Date of last data collection
Anticipated
1/05/2020
Actual
18/06/2020
Sample size
Target
160
Accrual to date
Final
163
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296390 0
Government body
Name [1] 296390 0
National Health and Medical Research Council
Country [1] 296390 0
Australia
Funding source category [2] 296391 0
Government body
Name [2] 296391 0
Victorian Department of Health and Human Services
Country [2] 296391 0
Australia
Funding source category [3] 296392 0
Charities/Societies/Foundations
Name [3] 296392 0
Disability Sport and Recreation
Country [3] 296392 0
Australia
Funding source category [4] 296393 0
Charities/Societies/Foundations
Name [4] 296393 0
YMCA VIctoria
Country [4] 296393 0
Australia
Funding source category [5] 296394 0
Charities/Societies/Foundations
Name [5] 296394 0
Cerebral Palsy Support Network
Country [5] 296394 0
Australia
Funding source category [6] 296395 0
Charities/Societies/Foundations
Name [6] 296395 0
Down Syndrome Victoria
Country [6] 296395 0
Australia
Funding source category [7] 296396 0
Charities/Societies/Foundations
Name [7] 296396 0
Joanne Tubb Foundation
Country [7] 296396 0
Australia
Funding source category [8] 296397 0
Government body
Name [8] 296397 0
Boroondara City Council
Country [8] 296397 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive,
Bundoora,
VIC 3086
Country
Australia
Secondary sponsor category [1] 295338 0
None
Name [1] 295338 0
Address [1] 295338 0
Country [1] 295338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297625 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 297625 0
Ethics committee country [1] 297625 0
Australia
Date submitted for ethics approval [1] 297625 0
Approval date [1] 297625 0
14/03/2017
Ethics approval number [1] 297625 0
HEC 17-012
Ethics committee name [2] 297626 0
Australian Catholic University
Ethics committee address [2] 297626 0
Ethics committee country [2] 297626 0
Australia
Date submitted for ethics approval [2] 297626 0
Approval date [2] 297626 0
27/03/2017
Ethics approval number [2] 297626 0
2017-63R
Ethics committee name [3] 300380 0
Deakin University
Ethics committee address [3] 300380 0
Ethics committee country [3] 300380 0
Australia
Date submitted for ethics approval [3] 300380 0
Approval date [3] 300380 0
10/08/2017
Ethics approval number [3] 300380 0
2017-206

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

Contacts
Principal investigator
Name 74634 0
Prof Nora Shields
Address 74634 0
Health Sciences Building 3,
School of Allied Health,
Kingsbury Drive,
La Trobe University,
Bundoora,
Victoria 3086
Country 74634 0
Australia
Phone 74634 0
+61 3 9479 5852
Fax 74634 0
Email 74634 0
[email protected]
Contact person for public queries
Name 74635 0
Nora Shields
Address 74635 0
Health Sciences Building 3,
School of Allied Health,
Kingsbury Drive,
La Trobe University,
Bundoora,
Victoria 3086
Country 74635 0
Australia
Phone 74635 0
+61 3 9479 5852
Fax 74635 0
Email 74635 0
[email protected]
Contact person for scientific queries
Name 74636 0
Nora Shields
Address 74636 0
Health Sciences Building 3,
School of Allied Health,
Kingsbury Drive,
La Trobe University,
Bundoora,
Victoria 3086
Country 74636 0
Australia
Phone 74636 0
+61 3 9479 5852
Fax 74636 0
Email 74636 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?
Data on the primary and secondary outcomes will be shared.
When will data be available (start and end dates)?
Data will be available after publication of the main trial outcomes (circa 2022 and no end date determined).
Available to whom?
Data will be available via open access.
Available for what types of analyses?
Secondary data analysis
How or where can data be obtained?
Data will be deposited in the La Trobe University library repository.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12844Study protocolShields N, Willis C, Imms C, Prendergast L, Watts J, van Dorsselaer B, McKenzie G, Bruder AM, Taylor NF. (2020). FitSkills: Protocol for a stepped wedge cluster randomised trial of a community-based exercise program to increase participation among young people with disability. BMJ Open 10:e037153.  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA 12-week exercise programme has a positive effect on everyday executive function in young people with Down syndrome: a pilot non-randomised controlled trial.2022https://dx.doi.org/10.1111/jir.12979
N.B. These documents automatically identified may not have been verified by the study sponsor.