Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000245695
Ethics application status
Approved
Date submitted
31/01/2023
Date registered
8/03/2023
Date last updated
8/03/2023
Date data sharing statement initially provided
8/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of individualised strength and conditioning versus games-based training on health-related components of fitness in young people with intellectual disability
Scientific title
The influence of individualised strength and conditioning versus games-based training on health-related components of fitness in young people with intellectual disability: An RCT
Secondary ID [1] 307653 0
None
Universal Trial Number (UTN)
U1111-1280-8966
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intellectual disability 327161 0
Condition category
Condition code
Physical Medicine / Rehabilitation 325854 325854 0 0
Other physical medicine / rehabilitation
Mental Health 326137 326137 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Individualised strength and conditioning (IS&C). Participants allocated to the IS&C group will complete one-on-one exercise training comprised of aerobic, resistance and flexibility training under the supervision of an exercise professional (30-45 minute sessions). Circuit training and interval training will be used for resistance and aerobic training, respectively. The exercise will be tailored to the participants physical abilities in terms of workload, complexity of exercises (single/double joint, functional, etc.). Training sessions will be performed at light to high intensity training according to a modified Borg RPE (/10) and percentage of heart rate max. Training will be performed at twice a week for 8 weeks.

Arm 2: Games-based training (GBT). Participants allocated to the GBT group will complete individual and small team-based games promoting physical activity and exercise. The training sessions will involve several short (5 to 10-min) games selected to provide different training stimuli (e.g. aerobic fitness, anaerobic fitness, coordination, strength, etc.) and will be time-matched to the IS&C group (30-45 minute sessions).
An example of an individual game is 'ten-pin bowling', where the remaining pins are counted and exercises are prescribed based on a pre-assigned number (e.g. 1 = 10 push ups, 2 = 15 sit to stands, etc.). An example of a team based game is 'rob the nest'. Teams of 3-5 are assigned hula hoops approximately 15 m from a basket full of bean bags. The teams are instructed to perform different exercises prior to running to retrieve a bean bag and bringing it back to their hula hoop for safe keeping. There are many variations to this team-based game but this is an example.
The GBT will include games performed at light to high intensity according to a modified Borg RPE (/10) and percentage of heart rate max. Training will be performed at twice a week for 8 weeks.

Arm 3: Wait-list control. Individuals in the wait-list control will not receive a treatment (i.e. physical exercise training) during the intervention period (8 week period).

Training intensity (% heart rate max) and workloads will be monitored using accelerometers and heart rate monitors. Session adherence will be monitored by an attendance checklist. The exercise training will be supervised and facilitated (in person) by exercise professionals, which will be conducted at the University of Southern Queensland Ipswich Campus (Ipswich, Queensland, Australia).
Intervention code [1] 324107 0
Lifestyle
Intervention code [2] 324108 0
Rehabilitation
Comparator / control treatment
No-exercise (no treatment) wait-list controls. The wait-list controls will be given a choice of completing one of the two treatments (IS&C or GBT) after the 8 week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 332112 0
Predicted peak oxygen uptake assessed from an incremental treadmill test to volitional exhaustion (cardiorespiratory fitness). Heart rate (via a chest strap and bluetooth watch) will be monitored throughout the test.

The treadmill protocol is as follows:
The treadmill speed is set to a comfortable walking pace (e.g. 3.2 to 5.6 kph).
4 minutes at 0%
4 minutes at 2.5%
4 minutes at 5%
4 minutes at 7.5%
2 minutes at 10%
2 minutes at 12.5%
The speed is then increased by 0.8 kph every 2 minutes until completion.
Timepoint [1] 332112 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention - primary endpoint) and 16-weeks (8-week follow up)
Secondary outcome [1] 412241 0
Seated, resting systolic blood pressure measured using an electronic blood pressure device
Timepoint [1] 412241 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [2] 412242 0
Seated, resting diastolic blood pressure measured using an electronic blood pressure device
Timepoint [2] 412242 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [3] 412243 0
Fat mass assessed by the InBody (BIA) Body Scanner.
Timepoint [3] 412243 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [4] 412244 0
Lean mass assessed by the InBody (BIA) Body Scanner.
Timepoint [4] 412244 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [5] 412245 0
Fat free mass assessed by the InBody (BIA) Body Scanner.
Timepoint [5] 412245 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [6] 412247 0
Bone mineral content assessed by the InBody (BIA) Body Scanner.
Timepoint [6] 412247 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [7] 412250 0
AFL agility test
Timepoint [7] 412250 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [8] 412253 0
10 meter timed heel to toe walk (dynamic balance).
Timepoint [8] 412253 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [9] 412260 0
Grip strength measured with a hand-held dynamometer.
Timepoint [9] 412260 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [10] 412263 0
Lower limb function assessed by a 30-second sit to stand test
Timepoint [10] 412263 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [11] 419066 0
Anaerobic power assessed by a Wingate (stationary cycle ergometer) test
Timepoint [11] 419066 0
Measured at baseline, 4-weeks (mid-intervention), 8-weeks (after the intervention) and 16-weeks (8-week follow up)
Secondary outcome [12] 419067 0
The Generic Children's Quality of Life Measure (GCQ) (boys' and girls' item booklets)
Timepoint [12] 419067 0
Measured at baseline, 8-weeks (after the intervention) and 16-weeks (8-week follow up)

Eligibility
Key inclusion criteria
Children and adolescents from 12 to 17 years of age;
Diagnosed with an intellectual disability (an intellectual quotient <70);
Free from cardiovascular disease and cancer;
Free from any musculoskeletal impairments that would limit their ability to participate in exercise training (ambulant/able-bodied);
Able to follow verbal instructions related to exercise testing and training.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children younger than 12 years and adults (18 years and older);
Children and adolescents with a profound intellectual disability according to the DSM-5 criteria;
Children and adolescents with behavioural problems that inhibit the successful completion of exercise testing or training;
Children and adolescents currently taking medication for cardiovascular diseases, type 2 diabetes or cancer.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to either Arm 1, Arm 2 or the control cohort (Arm 3) by drawing numbered balls (labelled 1, 2 and 3, respectively) from an opaque canister that is shaken between draws.
Once 12 participants have been assigned to each of the three arms of the study, participants will be stratified by sex to ensure balance between the three cohorts. This will be done prior to participant enrolment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomised controlled trial with two groups that will perform different types of exercise (individualised strength and conditioning or games-based training) and a non-exercise control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A one-way ANOVA will determine statistically significant differences in characteristics between the three cohorts at baseline.
A mixed model, repeated measures ANOVA will be conducted to determine statistically significant changes in the primary and secondary outcomes (e.g. 3 [groups] x 4 [time-points]).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/04/2023
Actual
Date of last participant enrolment
Anticipated
21/04/2023
Actual
Date of last data collection
Anticipated
5/01/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 38169 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 311915 0
University
Name [1] 311915 0
University of Southern Queensland
Country [1] 311915 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
University of Southern Queensland, 11 Salisbury Road, Ipswich, 4305, Queensland, Australia
Country
Australia
Secondary sponsor category [1] 313402 0
None
Name [1] 313402 0
Address [1] 313402 0
Country [1] 313402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311351 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [1] 311351 0
Ethics committee country [1] 311351 0
Australia
Date submitted for ethics approval [1] 311351 0
09/08/2022
Approval date [1] 311351 0
18/11/2022
Ethics approval number [1] 311351 0
H22REA254

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

Contacts
Principal investigator
Name 120810 0
Dr Joshua Denham
Address 120810 0
University of Southern Queensland, Ipswich Campus, 11 Salisbury Road, Ipswich, 4305, Queensland, Australia
Country 120810 0
Australia
Phone 120810 0
+61 7 3812 6347
Fax 120810 0
Email 120810 0
[email protected]
Contact person for public queries
Name 120811 0
Josh Denham
Address 120811 0
University of Southern Queensland, Ipswich Campus, 11 Salisbury Road, Ipswich, 4305, Queensland, Australia
Country 120811 0
Australia
Phone 120811 0
+61 7 3812 6347
Fax 120811 0
Email 120811 0
[email protected]
Contact person for scientific queries
Name 120812 0
Josh Denham
Address 120812 0
University of Southern Queensland, Ipswich Campus, 11 Salisbury Road, Ipswich, 4305, Queensland, Australia
Country 120812 0
Australia
Phone 120812 0
+61 7 3812 6347
Fax 120812 0
Email 120812 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 data from participants will be available on reasonable request to the principal investigator.
When will data be available (start and end dates)?
Immediately following the completion of the study and ending 5 years later.
Available to whom?
case-by-case basis at the discretion of principal investigator.
Available for what types of analyses?
To achieve the aims in the approved proposal or for meta-analyses.
How or where can data be obtained?
access subject to approvals by Principal Investigator: Dr Joshua Denham - [email protected]


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.