Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000172505
Ethics application status
Approved
Date submitted
20/01/2006
Date registered
12/05/2006
Date last updated
12/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Balance, strength and related falls risk factors in people with haemophilia and other bleeding disorders (PWH), and feasibility of a targeted home exercise program to improve balance.
Scientific title
Balance, strength and related falls risk factors in people with haemophilia and other bleeding disorders (PWH), and feasibility of a targeted home exercise program to improve balance.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemophilia and other bleeding disorders 1145 0
Condition category
Condition code
Blood 1225 1225 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two groups of participants will be recruited, a group of 30 adults with haemophilia and other bleeding disorders, and a goup of 30 age and gender matched controls. All participants will undergo a baseline assessment consisting of laboratory measures of balance, clinical measures of balance, falls history, falls risk, falls self efficacy, pain level, and disease severity. Following baseline assessments the haemophilia and other bleeding disorders group will be provided with an individualised, tailored balance and strengthening home exercise program. The balance and strengthening exercises will be selected from the Otago exercise program, and the exercises will be selected, by a qualified physiotherapist, based on results of the baseline assessment. Participants will undertake the exercise program for four months, with ongoing support from the physiotherapist. Following the exercise program intervention the participants from the haemophilia and other bleeding disorders group will have the baseline assessment measures repeated.
Intervention code [1] 851 0
None
Comparator / control treatment
No intervention is given to the controls.
Control group
Historical

Outcomes
Primary outcome [1] 1661 0
1. the falls and falls related history and balance and mobility as a risk factor for falls in people with haemophilia and other bleeding disorders
Timepoint [1] 1661 0
Measured at baseline
Primary outcome [2] 1662 0
2. whether an individualised tailored home exercise program targeting balance and strength in adults with haemophilia and other bleeding disorders will improve balance and strength in this population
Timepoint [2] 1662 0
Measured through the follow-up assessment at the conclusion of the exercise program
Secondary outcome [1] 2967 0
1. Which measures of balance performance (laboratory and clinical) are most useful in identifying balance impairment in people with haemophilia and other bleeding disorders.
Timepoint [1] 2967 0
Measured at baseline.
Secondary outcome [2] 2968 0
2. What the association is between balance performance and falls risk.
Timepoint [2] 2968 0
Measured at baseline.
Secondary outcome [3] 2969 0
3. What the association is between balance performance and falls efficacy.
Timepoint [3] 2969 0
Measured at baseline.
Secondary outcome [4] 2970 0
4. What the feasibility and effectiveness is of a tailored home exercise program in improving balance in adults with haemophilia and other bleeding disorders.
Timepoint [4] 2970 0
Measured at 4-month follow-up.

Eligibility
Key inclusion criteria
All participants must be willing and able to give informed consent. They must also be able to stand unsupported for greater than 30 seconds.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if there is presence of additional co-morbidities that confer risk of falls, or if they have had lower limb surgery within the previous two months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1337 0
Charities/Societies/Foundations
Name [1] 1337 0
Haemophilia Foundation of Australia
Country [1] 1337 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Haemophilia Foundation of Australia
Address
Country
Australia
Secondary sponsor category [1] 1180 0
None
Name [1] 1180 0
nil
Address [1] 1180 0
Country [1] 1180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2686 0
The Alfred Research and Ethics Committee
Ethics committee address [1] 2686 0
Ethics committee country [1] 2686 0
Australia
Date submitted for ethics approval [1] 2686 0
Approval date [1] 2686 0
27/10/2005
Ethics approval number [1] 2686 0
188/05

Summary
Brief summary
Health professionals working with people with haemophilia and other bleeding disorders (PWH) report a concern that patients appear to be at increased risk of falls and serious injuries from falls. However, to date there is no published research about falls risk in samples of adult haemophilia patients or any research quantifying the extent of balance dysfunction in PWH.

Therefore this project aims to:
- Determine which measures of balance performance are most useful in identifying balance impairment in PWH in comparison to healthy age and gender matched controls;
- Evaluate the association between balance performance and falls risk;
- Evaluate the association between balance performance and falls efficacy (confidence in mobility); and
- Evaluate the feasibility and effectiveness of a tailored home exercise program in improving balance and related outcomes for PWH.

Thirty adults with haemophilia or other bleeding disorders and 30 age and gender matched healthy adults will be recruited. All participants will undergo a baseline assessment of laboratory measures of balance, clinical measures of balance, falls risk, falls efficacy, activity level, pain, disease severity and health related quality of life.

Following the initial assessment the participants from the haemophilia group will be provided with an individually tailored balance and strengthening home exercise program from a physiotherapist, based on the results of the initial assessment. The participants will be required to undertake the home exercise program for four months, during which time they will receive two visits from the physiotherapist, who will review them and provide any support required.

At the end of the four month program the participants from the haemophilia group will undergo the baseline assessment again in order to evaluate their progress.

This pilot work will be useful to inform health care providers, and PWH, about the magnitude of the problem of balance dysfunction, what methods are most appropriate to identify this risk, and whether standard balance training exercises will be useful in this group. If successful, further studies will be required with a large sample to evaluate whether this approach can reduce falls in this group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36239 0
Address 36239 0
Country 36239 0
Phone 36239 0
Fax 36239 0
Email 36239 0
Contact person for public queries
Name 10040 0
Ms Marcia Fearn
Address 10040 0
National Ageing Research Institute
PO Box 31
Parkville VIC 3052
Country 10040 0
Australia
Phone 10040 0
+61 3 83872512
Fax 10040 0
+61 3 83872153
Email 10040 0
[email protected]
Contact person for scientific queries
Name 968 0
Associate Professor Keith Hill
Address 968 0
National Ageing Research Institute
PO Box 31
Parkville VIC 3052
Country 968 0
Australia
Phone 968 0
+61 3 83872639
Fax 968 0
+61 3 83872153
Email 968 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.