Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000938202
Ethics application status
Approved
Date submitted
2/11/2009
Date registered
2/11/2009
Date last updated
14/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A community based weight training program to improve work task performance in young adults with Down syndrome
Scientific title
A community based progressive resistance training program to improve work task performance in young adults with Down syndrome
Secondary ID [1] 283770 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Young people with Down syndrome 252092 0
Condition category
Condition code
Human Genetics and Inherited Disorders 252299 252299 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the experimental group will complete a 10-week progressive resistance training program. They will be taught 7 exercises: three exercises for the upper limbs, three exercises for the lower limbs and one exercise for the trunk. All exercises will be completed on weight machines in a local gymnasium. The training program is based on the recommendations of the American College of Sports medicine and will comprise 3 sets of 12 repetitions of each exercise at a training intensity of 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 physiotherapy student mentor.
Intervention code [1] 241484 0
Other interventions
Comparator / control treatment
Participants in the control group will complete a 10-weeks art and social program. The program will comprise art and recreational activities that would not be expected to have a fitness or training effect, such as painting, printing, music or social activities that do not incorporate a physical activity component. The program will be conducted once a week for 10 consecutive weeks. Each session will run for 90 minutes, approximately equal to the time spent in the 2 gymnasium sessions each week in the intervention group. Participants will complete the program with a physiotherapy student mentor.
Control group
Active

Outcomes
Primary outcome [1] 253172 0
Work task performance (repetitive weighted box stacking and weighted pail carry)
Timepoint [1] 253172 0
At baseline (week 0), immediately after the intervention has ceased (week 11) and 3 months after the intervention has ceased (week 24)
Secondary outcome [1] 262075 0
Muscle force generation (1 repetition maximum)
Timepoint [1] 262075 0
At baseline (week 0), immediately after the intervention has ceased (week 11) and 3 months after the intervention has ceased (week 24)
Secondary outcome [2] 262076 0
7-day Physical activity levels measured using accelerometry
Timepoint [2] 262076 0
At baseline (week 0), immediately after the intervention has ceased (week 11) and 3 months after the intervention has ceased (week 24)

Eligibility
Key inclusion criteria
(i) Adolescents and young adults with Down syndrome
(ii) Mild to moderate intellectual disability
(iii) Ability to follow simple verbal instructions in English.
(iv) Fit and well enough to participate in a high intensity progressive resistance training program.
Minimum age
14 Years
Maximum age
22 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) Participation in a progressive resistance training program in the 3 months prior to their participation in the trial.
(ii) A concurrent medical condition in addition to a diagnosis of Down syndrome that might impact on their ability to participate in an exercise program.

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
1/02/2010
Actual
17/07/2010
Date of last participant enrolment
Anticipated
Actual
19/05/2012
Date of last data collection
Anticipated
Actual
30/11/2012
Sample size
Target
70
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243951 0
Government body
Name [1] 243951 0
National Health and Medical Research Council (NHMRC)
Country [1] 243951 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University,
Victoria 3086
Country
Australia
Secondary sponsor category [1] 251307 0
None
Name [1] 251307 0
Address [1] 251307 0
Country [1] 251307 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244064 0
Ethics committee address [1] 244064 0
Ethics committee country [1] 244064 0
Date submitted for ethics approval [1] 244064 0
06/11/2009
Approval date [1] 244064 0
02/03/2010
Ethics approval number [1] 244064 0

Summary
Brief summary
This randomised controlled trial will compare the outcomes of a 10 week, twice a week community based exercise programme for young people with Down syndrome aged 14-22 years. It will establish if a student mentored intervention can improve the work performance, muscle strength and level of physical activity undertaken by young people with Down syndrome.
Trial website
Trial related presentations / publications
Shields N, Taylor N, Fernhall B. (2010). A study protocol of a randomised controlled trial to investigate if a community based strength training program improves work task performance in young adults with Down syndrome. BMC Pediatrics, 10, 17.

Shields N, Taylor N, Wee E, Wollersheim D, O’Shea S, Fernhall B (2013). A community-based strength training programme increases muscle strength and physical activity in young people with Down syndrome: A randomised controlled trial. Research in Developmental Disabilities 34, 4385–4394.

Shields N, Taylor N, Wee E, Wollersheim D, O’Shea S, Fernhall B (2013). Effects of student-mentored progressive resistance exercise training on work task performance and muscle strength in young people with Down syndrome: a randomized controlled trial. Developmental Medicine and Child Neurology, 55 (Supplement s3), 7. Presentation at the 2013 American Academy of Cerebral Palsy and Developmental Medicine
Public notes

Contacts
Principal investigator
Name 30444 0
Dr Nora Shields
Address 30444 0
Department of Physiotherapy,
La Trobe University,
Victoria 3086
Country 30444 0
Australia
Phone 30444 0
+61 3 9479 5852
Fax 30444 0
Email 30444 0
[email protected]
Contact person for public queries
Name 13691 0
Dr Dr Nora Shields
Address 13691 0
School of Physiotherapy,
La Trobe University,
Victoria 3086
Country 13691 0
Australia
Phone 13691 0
+61 3 9479 5852
Fax 13691 0
Email 13691 0
[email protected]
Contact person for scientific queries
Name 4619 0
Dr Dr Nora Shields
Address 4619 0
School of Physiotherapy,
La Trobe University,
Victoria 3086
Country 4619 0
Australia
Phone 4619 0
+61 3 9479 5852
Fax 4619 0
Email 4619 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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