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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
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
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Scientific title
Does a 12 Week Exercise Program Improve Cognitive Function in Young Adults with Down Syndrome?: A randomised trial
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Secondary ID [1]
297421
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Nil
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Universal Trial Number (UTN)
U1111-1228-6656
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Down syndrome
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Condition category
Condition code
Physical Medicine / Rehabilitation
310222
310222
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0
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Other physical medicine / rehabilitation
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Human Genetics and Inherited Disorders
310811
310811
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0
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Down's syndrome
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
313676
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Executive functioning: planning using the Tower of London Drexel edition.
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Assessment method [1]
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Timepoint [1]
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Baseline, 13 weeks after intervention commencement (primary timepoint)
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Primary outcome [2]
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Executive functioning: attention shifting using the Dimensional Change Card Sort Test from the NIH toolbox.
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Assessment method [2]
319106
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Timepoint [2]
319106
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Baseline, 13 weeks after intervention commencement (primary timepoint)
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Primary outcome [3]
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Executive functioning: inhibition: inhibitory control using Sustained Attention to Response Task and the Flanker Inhibitory Control/Attention test from the NIH tollbox.
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Assessment method [3]
319518
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Timepoint [3]
319518
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Baseline. 13 weeks after intervention commencement (primary timepoint)
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Secondary outcome [1]
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Cognitive function will be assessed using the cognitive scale for Down syndrome
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Assessment method [1]
366990
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Timepoint [1]
366990
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Baseline, 13 weeks after intervention commencement
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Secondary outcome [2]
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Short term memory, assessed using the Paired Associates Learning Task from CANTAB (measuring visuospatial memory).
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Assessment method [2]
368558
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Timepoint [2]
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Baseline, 13 weeks after intervention commencement
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Secondary outcome [3]
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Information processing speed will be measured using the Modified inspection time task
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Assessment method [3]
368559
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Timepoint [3]
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Baseline, 13 weeks after intervention commencement
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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.
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Minimum age
15
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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;
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
COVID-19 - Gyms closed, unable to complete assessment etc.
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Date of first participant enrolment
Anticipated
23/08/2019
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Actual
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Date of last participant enrolment
Anticipated
30/09/2019
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Actual
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Date of last data collection
Anticipated
30/06/2020
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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La Trobe University
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Address [1]
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La Trobe University
Bundoora, VIC, 3086
AUSTRALIA
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Country [1]
301992
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
La Trobe University
Bundoora, VIC, 3086
AUSTRALIA
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
301771
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None
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Address [1]
301771
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Country [1]
301771
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302667
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La Trobe University Human Research Ethics Committee.
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Ethics committee address [1]
302667
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La Trobe University Bundoora, VIC, 3086 AUSTRALIA
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Ethics committee country [1]
302667
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Australia
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Date submitted for ethics approval [1]
302667
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16/11/2018
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Approval date [1]
302667
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11/02/2019
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Ethics approval number [1]
302667
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HEC18495
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Darren Hocking
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Address
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Developmental Neuromotor and Cognition Lab
Rm 119
Biological Sciences 2
La Trobe University
Bundoora
Victoria, 3086
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Country
90998
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Australia
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Phone
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+61 394795462
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Darren Hocking
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Address
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Developmental Neuromotor and Cognition Lab
Rm 119
Biological Sciences 2
La Trobe University
Bundoora
Victoria, 3086
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Country
90999
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Australia
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Phone
90999
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+61 394795462
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Fax
90999
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Email
90999
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[email protected]
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Contact person for scientific queries
Name
91000
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Darren Hocking
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Address
91000
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Developmental Neuromotor and Cognition Lab
Rm 119
Biological Sciences 2
La Trobe University
Bundoora
Victoria, 3086
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Country
91000
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Australia
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Phone
91000
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+61 394795462
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Fax
91000
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Email
91000
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
underlying published results only
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When will data be available (start and end dates)?
Immediately following publication ending 5 years following main results publication;
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Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
for IPD meta-analyses
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How or where can data be obtained?
Access subject to approvals by Principal Investigator, requirement to sign data access agreement
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
1373
Informed 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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No documents have been uploaded by study researchers.
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No additional documents have been identified.
Download to PDF