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Trial registered on ANZCTR


Registration number
ACTRN12608000261314
Ethics application status
Approved
Date submitted
21/05/2008
Date registered
22/05/2008
Date last updated
14/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Is a peer-led strength training program beneficial for adolescents with Down syndrome?
Scientific title
A 10-week peer-led strength training program to improve the strength and physical function of adolescents with Down syndrome: a randomised controlled trial
Secondary ID [1] 288005 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescents with Down syndrome 3177 0
Condition category
Condition code
Human Genetics and Inherited Disorders 3336 3336 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental group intervention: Participants in the experimental group will complete a 10-week progressive resistance strength training program. They will be taught three exercises for the major muscle groups of the upper body (lat pull down, seated chest press, seated row) and three exercises for the major anti-gravity support muscles of the lower body (seated leg press, knee extension, seated calf raise). All exercises will be completed on weight machines in the local gymnasium. The training details will be based on recommendations of the American College of Sports Medicine (2002) and will consist of 3 sets of 10-12 repetitions of each exercise, at a training intensity of 10-12RM. The weight lifted in each exercise will be increased when 3 sets of 12 repetitions of an exercise can be completed. Two-minute rest periods will be given between each exercise set. The program will be conducted twice weekly for 10 consecutive weeks. Participants will complete the program with a peer mentor (undergraduate physiotherapy student).
Intervention code [1] 2909 0
Treatment: Other
Comparator / control treatment
Control group: Participants in the control group will continue with their typical daily activities, which may include leisure and sporting activities, but will not include a progressive resistance strength training program.
Control group
Active

Outcomes
Primary outcome [1] 4225 0
Muscle force generation (1RM)
Timepoint [1] 4225 0
At baseline and 1 week after the intervention has ceased
Secondary outcome [1] 7140 0
Timed up and down stairs test and grocery shelving task.
Timepoint [1] 7140 0
At baseline and 1 week after the intervention has ceased

Eligibility
Key inclusion criteria
(1) Ability to follow simple instructions in English, (2) fit and well enough to participate in a strength training program.
Minimum age
13 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If the adolescent has participated in a strength training program in the 6 months prior to the start of the study.

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
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3413 0
Charities/Societies/Foundations
Name [1] 3413 0
Windermere Foundation
Address [1] 3413 0
Windermere Foundation Ltd
GPO Box 4377
MELBOURNE VIC 3001
Country [1] 3413 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University,
Victoria 3086
Country
Australia
Secondary sponsor category [1] 3057 0
None
Name [1] 3057 0
Address [1] 3057 0
Country [1] 3057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293926 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 293926 0
Ethics committee country [1] 293926 0
Australia
Date submitted for ethics approval [1] 293926 0
Approval date [1] 293926 0
13/05/2008
Ethics approval number [1] 293926 0
08-024

Summary
Brief summary
This trial has now been completed and recruited 20 adoelcents with Dwon syndrome who were randomly allocation to either a progressive resistance training intervention group or a wait list control group.
Trial website
Trial related presentations / publications
Shields N, Taylor N. (2010). Effects of a student-led progressive resistance training program on muscle strength and physical function in adolescents with Down syndrome. Journal of Physiotherapy, 56, 187-193.

Shields N, Bruder A, Taylor N, Angelo T. (2011). An alternative clinical experience can positively change physiotherapy student attitudes. Disability & Rehabilitation, 33, 360-6.

Shields N, Bruder A, Taylor N, Angelo T (2013). Getting fit for practice: an innovative paediatric clinical placement provided physiotherapy students opportunities for skill development. Physiotherapy 99, 159–164.

Shields N, Taylor N (2010). Community based student mentored strength training programme for adolescents with Down syndrome. Developmental Medicine and Child Neurology, 52 (Suppl 2), 29

Shields N, Taylor N, Bruder A, Angelo T (2010). Getting fit for practice: Designing meaningful practice based education for undergraduate students. Higher Education Research and Development Society of Australasia International Conference, Melbourne, 6-9 July 2010.

Shields N, Taylor N (2010). Community based student mentored strength training programme for adolescents with Down syndrome. Australasian Academy of Cerebral Palsy and Developmental Medicine 5th Bi-Annual Conference, Christchurch, 4-6 March 2010.

Shields N, Taylor N (2009). A randomised controlled trial on the effects of a community-based exercise program for adolescents with Down syndrome. Australian Physiotherapy Association Conference Week, Sydney, 1-5 October 2009.

Shields N, Taylor N, Bruder A (2009). Learning outcomes for physiotherapy students who engaged in an alternate paediatric clinical experience. Australian Physiotherapy Association Conference Week, Sydney, 1-5 October 2009.
Public notes

Contacts
Principal investigator
Name 28606 0
Dr Nora Shields
Address 28606 0
School of Allied Health, La Trobe University, VIC 3086
Country 28606 0
Australia
Phone 28606 0
+61 3 9479 5852
Fax 28606 0
Email 28606 0
n.shields@latrobe.edu.au
Contact person for public queries
Name 11763 0
Dr Dr Nora Shields
Address 11763 0
School of Physiotherapy,
La Trobe University,
Victoria 3086
Country 11763 0
Australia
Phone 11763 0
+61 3 9479 5852
Fax 11763 0
Email 11763 0
N.Shields@latrobe.edu.au
Contact person for scientific queries
Name 2691 0
Dr Dr Nora Shields
Address 2691 0
School of Physiotherapy,
La Trobe University,
Victoria 3086
Country 2691 0
Australia
Phone 2691 0
+61 3 9479 5852
Fax 2691 0
Email 2691 0
N.Shields@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary