Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000565145
Ethics application status
Approved
Date submitted
4/04/2019
Date registered
10/04/2019
Date last updated
16/07/2021
Date data sharing statement initially provided
10/04/2019
Date results information initially provided
4/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a 12­ Week Exercise Program Improve Cognitive Function in Young Adults with Down Syndrome?: A randomised feasibility trial
Scientific title
Does a 12­ Week Exercise Program Improve Cognitive Function in Young Adults with Down Syndrome?: A randomised trial
Secondary ID [1] 297421 0
Nil
Universal Trial Number (UTN)
U1111-1228-6656
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Down syndrome 311595 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310222 310222 0 0
Other physical medicine / rehabilitation
Human Genetics and Inherited Disorders 310811 310811 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise program will match participants with Down syndrome (DS) with a student mentor from their community to exercise together, one­-on­-one at their local gym. The program will be a 12­ week program, with two, one hour sessions per week (24 sessions in total). The exercise program will comprise progressive resistance training (weight training). Programs will be prescribed by a physiotherapist from the research team, according to international best practice guidelines from the American College of Sports Medicine. Participants and mentors will document programs and notes in an exercise logbook. Mentors will be recruited from Allied Health students at La Trobe University Bundoora (any discipline and any year). All mentors are paid employees, based on residential location and will hold a current police check and working with children's check.

An Experimental group will complete the 12-­week exercise program twice a week and will log the exercises performed and the intensity at which they are performed (e.g. weight/ resistance used, number of repetitions). A control group will continue with their usual activities for 12 weeks and receive the exercise intervention after their second assessment.
Intervention code [1] 313676 0
Treatment: Other
Comparator / control treatment
A wait list group to receive intervention at a later date (control group).
The wait list group will be offered the intervention after their second assessment at week 13.
Control group
Active

Outcomes
Primary outcome [1] 319105 0
Executive functioning: planning using the Tower of London Drexel edition.
Timepoint [1] 319105 0
Baseline, 13 weeks after intervention commencement (primary timepoint)
Primary outcome [2] 319106 0
Executive functioning: attention shifting using the Dimensional Change Card Sort Test from the NIH toolbox.
Timepoint [2] 319106 0
Baseline, 13 weeks after intervention commencement (primary timepoint)
Primary outcome [3] 319518 0
Executive functioning: inhibition: inhibitory control using Sustained Attention to Response Task and the Flanker Inhibitory Control/Attention test from the NIH tollbox.
Timepoint [3] 319518 0
Baseline. 13 weeks after intervention commencement (primary timepoint)
Secondary outcome [1] 366990 0
Cognitive function will be assessed using the cognitive scale for Down syndrome
Timepoint [1] 366990 0
Baseline, 13 weeks after intervention commencement
Secondary outcome [2] 368558 0
Short term memory, assessed using the Paired Associates Learning Task from CANTAB (measuring visuospatial memory).
Timepoint [2] 368558 0
Baseline, 13 weeks after intervention commencement
Secondary outcome [3] 368559 0
Information processing speed will be measured using the Modified inspection time task
Timepoint [3] 368559 0
Baseline, 13 weeks after intervention commencement

Eligibility
Key inclusion criteria
(1) Diagnosed with Down syndrome
(2) can respond verbally to, and follow simple verbal instructions in English
(3) are medically fit to participate in an exercise program.
Minimum age
15 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they: .
(1) participate in a structured exercise program within three months prior to the trial;
(2) have an acute or concurrent medical condition rendering them unfit to take part (e.g. severe osteoarthritis, severe cardiac conditions); or
(3) have a significant behavioural problem that would impact on participation (e.g. 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)
Participants will be randomly assigned using sequentially numbered sealed opaque envelopes prepared by an independent researcher with no role in recruitment or assessment;

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned using a permuted block design created by a computer random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 30 participants will be recruited for this phase I feasibility trial. A sample size of n=30 would be sufficient detect a large effect of 0.55 at power of 0.8 and alpha level of 0.05. However, for this type of intervention it is not expected likely that a large effect of 0.55 favouring the intervention group will be found. However, a sample size of n=30 will enable estimates of the standardised mean difference to inform design of a phase II trial.
Data will be analysed depending on allocation (intention to treat analysis) using Analysis of Covariance (ANCOVA) with baseline values as co­variate. If more than 5% of data is missing, a multiple imputation process will be used, leading to the assumption that data are missing at random is met.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID-19 - Gyms closed, unable to complete assessment etc.
Date of first participant enrolment
Anticipated
23/08/2019
Actual
Date of last participant enrolment
Anticipated
30/09/2019
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301992 0
University
Name [1] 301992 0
La Trobe University
Country [1] 301992 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Bundoora, VIC, 3086
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 301771 0
None
Name [1] 301771 0
None
Address [1] 301771 0
Country [1] 301771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302667 0
La Trobe University Human Research Ethics Committee.
Ethics committee address [1] 302667 0
La Trobe University
Bundoora, VIC, 3086
AUSTRALIA
Ethics committee country [1] 302667 0
Australia
Date submitted for ethics approval [1] 302667 0
16/11/2018
Approval date [1] 302667 0
11/02/2019
Ethics approval number [1] 302667 0
HEC18495

Summary
Brief summary
We want to determine the effect of regular exercise on cognitive functioning in young adults with Down syndrome. We will compare the effect of a 12-­week exercise intervention on cognitive function against a wait list control group.
Participants will complete a weight training program with a mentor to assist them, at a local gym. Exercise sessions will run for one hour, twice a week for 12 weeks.
We will recruit a 30 participants aged 15-35 years old with Down syndrome. Baseline data on Executive functioning, Short ­term Memory, Information processing speed and Intellectual ability will be collected at baseline (week 0). Executive functioning, Short ­term Memory and Information processing speed will be measured again during follow­-up (week 13) after having either completed the exercise program or doing their usual activities. We will also collect data on participant demographics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90998 0
Dr Darren Hocking
Address 90998 0
Developmental Neuromotor and Cognition Lab
Rm 119
Biological Sciences 2
La Trobe University
Bundoora
Victoria, 3086
Country 90998 0
Australia
Phone 90998 0
+61 394795462
Fax 90998 0
Email 90998 0
[email protected]
Contact person for public queries
Name 90999 0
Dr Darren Hocking
Address 90999 0
Developmental Neuromotor and Cognition Lab
Rm 119
Biological Sciences 2
La Trobe University
Bundoora
Victoria, 3086
Country 90999 0
Australia
Phone 90999 0
+61 394795462
Fax 90999 0
Email 90999 0
[email protected]
Contact person for scientific queries
Name 91000 0
Dr Darren Hocking
Address 91000 0
Developmental Neuromotor and Cognition Lab
Rm 119
Biological Sciences 2
La Trobe University
Bundoora
Victoria, 3086
Country 91000 0
Australia
Phone 91000 0
+61 394795462
Fax 91000 0
Email 91000 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?
underlying published results only
When will data be available (start and end dates)?
Immediately following publication ending 5 years following main results publication;
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator, requirement to sign data access agreement


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1373Informed consent form    376985-(Uploaded-15-02-2019-11-38-10)-Study-related document.docx



Results publications and other study-related documents

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