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Trial registered on ANZCTR


Registration number
ACTRN12606000515594
Ethics application status
Approved
Date submitted
11/12/2006
Date registered
12/12/2006
Date last updated
14/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is a 10-week community-based strength training program beneficial for adults with Down syndrome?
Scientific title
A 10-week community-based strength training program to improve the strength and physical function of adults with Down syndrome: a randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adults with Down syndrome 1492 0
Condition category
Condition code
Human Genetics and Inherited Disorders 1589 1589 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 2 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 2 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 for twice weekly for 10 consecutive weeks. Participants will complete the program as a group, supervised by trainers with experience in teaching strengthening programs. Each trainer will supervise the training of a sub-group of four participants.
Intervention code [1] 1500 0
Treatment: Other
Comparator / control treatment
Control group: Participants in the control group will continue with their typical daily activities, which may include employment, leisure and sporting activities, but will not include a progressive resistance strength training program.
Control group
Active

Outcomes
Primary outcome [1] 2193 0
Muscle force generation (1RM)
Timepoint [1] 2193 0
At baseline and 1 day after the intervention has ceased
Secondary outcome [1] 3823 0
Gross motor function measurement, timed up and down stairs test and grocery shelving task.
Timepoint [1] 3823 0
Baseline and 1 day 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
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the person 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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random numbers table from a statistics book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors will be blinded
Phase
Type of endpoint(s)
Safety/efficacy
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] 1734 0
University
Name [1] 1734 0
Faculty of Health Sciences, La Trobe University
Address [1] 1734 0
Faculty of Health Sciences,
La Trobe University,
Victoria 3086.
Country [1] 1734 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Faculty of Health Sciences
La Trobe University
VIC 3086
Country
Australia
Secondary sponsor category [1] 1528 0
None
Name [1] 1528 0
Nil
Address [1] 1528 0
Country [1] 1528 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3205 0
La Trobe University Faculty of Health Sciences Human Ethics Committee
Ethics committee address [1] 3205 0
Ethics committee country [1] 3205 0
Australia
Date submitted for ethics approval [1] 3205 0
Approval date [1] 3205 0
03/08/2006
Ethics approval number [1] 3205 0
FHEC06/94

Summary
Brief summary
This study will compare the effects of a gymnasium-based strength training program to usual care in people with Down syndrome.
Trial website
Trial related presentations / publications
Shields N, Taylor NF, Dodd KJ (2008). Effects of a community-based progressive resistance strength training program on muscle performance and physical function in adults with Down syndrome. a randomised controlled trial. Developmental Medicine and Child Neurology, 50 (Suppl 113), 39.

Shields N, Taylor N, Dodd KJ. (2008). Effects of a community-based progressive resistance strength training program on muscle performance and physical function in adults with Down syndrome: a randomized controlled trial. Archives of Physical Medicine and Rehabilitation, 89, 1215-1220.
Public notes

Contacts
Principal investigator
Name 27434 0
Address 27434 0
Country 27434 0
Phone 27434 0
Fax 27434 0
Email 27434 0
Contact person for public queries
Name 10689 0
Dr Nora Shields
Address 10689 0
School of Physiotherapy
La Trobe University
VIC 3086
Country 10689 0
Australia
Phone 10689 0
+61 3 94795852
Fax 10689 0
Email 10689 0
N.Shields@latrobe.edu.au
Contact person for scientific queries
Name 1617 0
Dr Nora Shields
Address 1617 0
School of Physiotherapy
La Trobe University
VIC 3086
Country 1617 0
Australia
Phone 1617 0
+61 3 94795852
Fax 1617 0
Email 1617 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