Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000224628
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
26/08/2005
Date last updated
26/08/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Aerobic Fitness, Strength and Quality of Life in Children with Haemophilia
Scientific title
The effect of an exercise intervention on quality of life, aerobic fitness and strength in children with haemophilia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemophilia 310 0
Condition category
Condition code
Human Genetics and Inherited Disorders 353 353 0 0
Other human genetics and inherited disorders
Blood 354 354 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a clinical trial of exercise for children with haemophilia. The treatment group will receive a general exercise program (aerobic exercise and resistance training) lasting 12 weeks. The effects of the control and exercise treatments will be measured at the beginning and end of the exercise program.
Intervention code [1] 248 0
Treatment: Other
Comparator / control treatment
In this study the control group will receive usual care.
Control group
Active

Outcomes
Primary outcome [1] 408 0
Quality of life
Timepoint [1] 408 0
Measured at baseline and immediately following the intervention
Primary outcome [2] 409 0
Strength
Timepoint [2] 409 0
Measured at baseline and immediately following the intervention
Primary outcome [3] 410 0
Cardio-vascular fitness (VO2 peak)
Timepoint [3] 410 0
Measured at baseline and immediately following the intervention
Secondary outcome [1] 883 0
1.Number of haemarthroses - self-reported throughout intervention
Timepoint [1] 883 0
Secondary outcome [2] 884 0
2.Lean tissue mass, body fat
Timepoint [2] 884 0
Measured at baseline and immediately following intervention.
Secondary outcome [3] 885 0
3. Adverse events (other than haemarthroses) associated with exercise or physical activity.
Timepoint [3] 885 0
These will be elicited by open-ended questioning during the intervention.

Eligibility
Key inclusion criteria
To participate in the study children must fulfill the following inclusion criteria: - Diagnosis of mild, moderate or severe haemophilia (A or B) or Von Willebrands disease- Patient/guardian and child agrees to accept randomisation to either intervention or control group.
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They have Factor VIII antibodies- They live outside the Sydney metropolitan region and therefore cannot attend for intervention- Any contraindication to aerobic or resistance training- They are involved in organised physical activity for more than 3 sessions (>1 hour) per week.

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)
sequentially numbered, sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated numbers in randomly permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 412 0
Hospital
Name [1] 412 0
Children's Hospital Institute of Sports Medicine
Country [1] 412 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 333 0
None
Name [1] 333 0
Nil
Address [1] 333 0
Country [1] 333 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36301 0
Address 36301 0
Country 36301 0
Phone 36301 0
Fax 36301 0
Email 36301 0
Contact person for public queries
Name 9437 0
Dr Carolyn Broderick
Address 9437 0
Children's Hospital Institute of Sports Medicine
Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 9437 0
Australia
Phone 9437 0
+61 2 98450761
Fax 9437 0
Email 9437 0
c.broderick@unsw.edu.au
Contact person for scientific queries
Name 365 0
Dr Carolyn Broderick
Address 365 0
Children's Hospital Institute of Sports Medicine
Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 365 0
Australia
Phone 365 0
+61 2 98450761
Fax 365 0
Email 365 0
c.broderick@unsw.edu.au

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.