Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000808943
Ethics application status
Approved
Date submitted
30/07/2011
Date registered
2/08/2011
Date last updated
2/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical Activity Benefits of Learning to Ride a Two- Wheel Bicycle for Children with Down Syndrome: A Randomized Trial
Scientific title
Physical Activity Benefits of Learning to Ride a Two- Wheel Bicycle for Children with Down Syndrome: A Randomized Trial
Secondary ID [1] 262746 0
Nil known
Universal Trial Number (UTN)
U1111-1123-2957
Trial acronym
PABDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity and Down syndrome 270455 0
Subcutaneous fat and Down syndrome 270456 0
Condition category
Condition code
Public Health 270608 270608 0 0
Health promotion/education
Human Genetics and Inherited Disorders 270623 270623 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individualized bicycle training via Lose the Training Wheels protocol is implemented on a one-on-one basis for 75 minutes per day for 5 consecutive days. The total duration of training is 5 days. The primary focus is on maximizing the amount of time the rider is on the bicycle practicing within the 75 minute session. The training begins with an adapted bicycle that has a series of 8 different roller wheels rather than a standard wheel on the back. As the roller wheels go from 1-8, the rollers become more tapered on the ends requiring better control of the bicycle. There is also a bicycle training handle attached to the back of the bicycle to afford the trainer with a system of prompting the rider to lean into the turns and to stop the rider from falling or running into stationary objects. Eight riders participant with their trainer in each 75 minute training session and then go home until the next day of training. Riders begin to transition onto a standard two wheel bicycle once they demonstate good control of the training bicycle and learn to stop using hand breaks. Initial training occurs indoors until they transition to a two wheel bicycle at which time they move out of doors with their trainer. Those riders who succeed in making a transition onto a two wheel bicycle are encouraged to bring their own bicycle the last day of training.
Intervention code [1] 267091 0
Lifestyle
Comparator / control treatment
Control group waited 12 months to receive intervention. Assignment to groups was random.
Control group
Active

Outcomes
Primary outcome [1] 269341 0
Average minutes per day in sedentary activity. Level of activity and time spent per day in sedentary, moderate and vigorous activity was objectively measured using an Actical activity monitor worn on the right hip for a minimum of 10 hours per day for 7 consecutive days at each of the 3 time points.
Timepoint [1] 269341 0
Preintervention, 3 months post intervention (Post 1), 12 months post intervention (Post 2)
Secondary outcome [1] 279413 0
sum of subcutaneous fat measured via skinfold calipers
Timepoint [1] 279413 0
Preintervention, 12 months post intervention (Post 1)

Eligibility
Key inclusion criteria
Diagnosed with Down syndrome, age 8-15 years, healthy
Minimum age
8 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any medical conditions that would preclude involvement in moderate levels of physical activity (eg, uncontrolled seizures).

Study design
Purpose of the study
Educational / counselling / training
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
15/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 3760 0
United States of America
State/province [1] 3760 0

Funding & Sponsors
Funding source category [1] 267561 0
Charities/Societies/Foundations
Name [1] 267561 0
National Down Syndrome Society
Country [1] 267561 0
United States of America
Primary sponsor type
University
Name
University of Michigan
Address
1402 Washington Heights
Ann Arbor, MI 48109-2013
Country
United States of America
Secondary sponsor category [1] 266603 0
Charities/Societies/Foundations
Name [1] 266603 0
Lyle Foundation
Address [1] 266603 0
350 East 79th St
# 37A
New York, NY 10021
Country [1] 266603 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269524 0
Institutional Review Board Health Sciences
Ethics committee address [1] 269524 0
540 East Liberty
Suite 202
Ann Arbor, MI 48104-2210
Ethics committee country [1] 269524 0
United States of America
Date submitted for ethics approval [1] 269524 0
Approval date [1] 269524 0
17/03/2005
Ethics approval number [1] 269524 0
H05-00008264

Summary
Brief summary
The primary purpose of the study was to determine the rate of success in learning how to ride a two wheel bicycle in youth with Down syndrome and to evaluate if those participants who learned to ride, decreased their average amount of sedentary activity and subcutaneous body fat compared to the control group over a 12 month period. Our hypothesis was that those participants who learned to ride a two wheel bicycle would benefit more than those participants in the control group over the 12 month period following the treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32956 0
Address 32956 0
Country 32956 0
Phone 32956 0
Fax 32956 0
Email 32956 0
Contact person for public queries
Name 16203 0
Dale A Ulrich
Address 16203 0
1402 Washington Heights
University of Michigan
Ann Arbor, MI 48109-2013
Country 16203 0
United States of America
Phone 16203 0
1-734-615-1904
Fax 16203 0
Email 16203 0
[email protected]
Contact person for scientific queries
Name 7131 0
Dale A Ulrich
Address 7131 0
1402 Washington Heights
University of Michigan
Ann Arbor, MI 48109-2013
Country 7131 0
United States of America
Phone 7131 0
1-734-615-1904
Fax 7131 0
Email 7131 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.