Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000040369
Ethics application status
Approved
Date submitted
22/01/2008
Date registered
23/01/2008
Date last updated
4/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Balance dysfunction and falls risk in early dementia-Magnitude of the problem, and effectiveness of balance training program.
Scientific title
In people with early diagnosed Alzheimer's disease, will a home based balance exercise programme be effective in improving balance performance and quality of life of the patients and their caregivers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia (mild to moderate) 2740 0
Balance dysfunction 2741 0
Condition category
Condition code
Neurological 2865 2865 0 0
Dementias
Physical Medicine / Rehabilitation 2866 2866 0 0
Physiotherapy
Injuries and Accidents 2867 2867 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will participate in a home based balance exercise programme, provided at home by an experienced physiotherapist. This exercise programme is modified from an existing home exercise programme “Otaogo programme” to suit people with memory difficulties, and will be tailored to the results of the balance and mobility assessments. The Otago programme has been shown in a number of studies of older people to reduce falls. The exercise programme will be structured to be performed at least 5 times each week, and will have a focus on standing balance and strengthening exercise, as well as a graduated walking programme. The physiotherapist will provide six home visits over the six month period, to monitor, advise, and modify the programme as required. The frequency of home visits in this study is slightly increased on the successful Otago programme (4 visits), aiming to maximise safety with increased visits particularly in the first 6-8 weeks of the programme. An exercise booklet will be provided by the physiotherapist to each pariticipant to give illustrations and instructions for the participant to continue the exercise programme at home. In between visit, the physiotherapist will contact participant by telephone.
Intervention code [1] 2480 0
Rehabilitation
Comparator / control treatment
There will be 3 sub-groups of participants. One intervention group (107 patients with recently diagnosed Alzheimer's dementia) will be provided with a home based balance exercise program. A futher 107 patients with recently diagnosed Alzheimer's dementia will receive a home occupational therapy programme involving six home visits for the six month duration by an experienced Occupational Therapist, to provide an information / education programme focusing on a mixture of social activities, psychological support, and maintenance of Activities of Daily Living advice. This programme will be based on a programme for people with dementia by Graff et al (2007). These Occupational Therapy (OT) home visit sessions will avoid any messages encouraging change in activity.
Control group
Active

Outcomes
Primary outcome [1] 3749 0
Laboratory measures of balance (NeuroCom Balance Master: long plate). e.g. Modified Clinical Test of Sensory Interaction on Balance, composite score.
Timepoint [1] 3749 0
At baseline and at 6, 12, 24 months after randomisation
Primary outcome [2] 3750 0
Clinical measures of balance and mobility, e.g. Step Test, number of steps in 15 seconds (worst leg).
Timepoint [2] 3750 0
At baseline and at 6, 12, 24 months after randomisation
Primary outcome [3] 3751 0
Falls and falls risk measure by FROP-community assessment and the Lord's abbreviated Physiological Profile Assesment
Timepoint [3] 3751 0
At baseline and at 6, 12, 24 months after randomisation
Secondary outcome [1] 6335 0
Carer burden measured by the Zarit Carer Burden Scale
Timepoint [1] 6335 0
At baseline and at 6, 12, 24 months after randomisation
Secondary outcome [2] 6336 0
Quality of life measured by the Assessment of Quality of Life (AQoL)
Timepoint [2] 6336 0
At baseline and at 6, 12, 24 months after randomisation

Eligibility
Key inclusion criteria
Older people with recent diagnosis of Alzheimer's disease, of mild to moderate severity, independent mobility, no other serious neurological or othopaedic history that impacts on balance and mobility performance.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-dementia diagnosis or dementia diagnosis other than Alzheimer's disease, Alzheimer's disease more than 12 months or severe dementia, limited mobility.

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)
Participants will be informed about the study by a geriatrician at the CDAMS Clinic at the time or shortly after the time a patient is diagnosed with Alzheimer's disease. They will obtain permission from the participant or the person responsible for the research team to contact them about the research project. Following contact by the research team, and agreement to participate, participants who finish the baseline assessment will be allocated to one of the two intervention groups by a research assistant who is independent of the assessors. She will communicate with the participants and their caregivers and advise them which group they are in and the next phases of the project. Allocation was concealed by using numbered opaque envelopes, the next consecutive one opened for each consecutive participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers table generated by a computer software to determine group allocation for each participant ID number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
264
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 738 0
3021
Recruitment postcode(s) [2] 739 0
3052

Funding & Sponsors
Funding source category [1] 3010 0
Self funded/Unfunded
Name [1] 3010 0
National Ageing Research Institute
Country [1] 3010 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute (NARI)
Address
34-54 Poplar Road, PO Box 31
Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 2703 0
None
Name [1] 2703 0
Address [1] 2703 0
Country [1] 2703 0
Other collaborator category [1] 166 0
Hospital
Name [1] 166 0
Royal Melbourne Hospital (Royal Park Campus)
Address [1] 166 0
34-54 Poplar Road, Parkville, Victoria 3052
Country [1] 166 0
Australia
Other collaborator category [2] 167 0
Hospital
Name [2] 167 0
The Sunshine Hospital (Western Health)
Address [2] 167 0
Furlong Road, St Albans, Victoria 3021
Country [2] 167 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4955 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 4955 0
PO Royal Melbourne Hospital, Parkville, VIC, 3050
Ethics committee country [1] 4955 0
Australia
Date submitted for ethics approval [1] 4955 0
25/01/2008
Approval date [1] 4955 0
16/04/2008
Ethics approval number [1] 4955 0
HREC 2008.004

Summary
Brief summary
Two hundred and fourteen participants with mild to moderate severity of Alzheimer’s disease will be recruited for the randomised controlled trial. Sixty-four age and gender matched (to first 64 people with Alzheimer’s dementia in the control group) healthy participants will be recruited for the longitudinal study. A series of laboratory and clinical measures will be used to investigate balance and mobility performances. All participants will undergo a full assessment process as the baseline, and will then be randomized to a control or an intervention group. The participants in the intervention group will undertake an individually tailored balance training at home programme of 6 months duration. This exercise programme will be based on the results of the balance assessment and conducted under the guidelines which is modified from the established “Otago” programme by a physiotherapist. For the control group, the participants will be provided six home visits by an occupational therapist. Both intervention group and control group will continue with their “usual care” programme as recommended by the Cognitive, Dementia and Memory Services (CDAMS). All participants will be re-assessed at the completion of the programme (after 6 months), and again in a further six months. Additionally, the first 64 participants of the control group with mild to moderate severity Alzheimer’s disease, and 64 age and gender matched healthy controls will be re-assessed on all measures again after 24 months to determine the longitudinal changes in balance performance and magnitude of balance dysfunction. This study will give improved understanding of the changes in balance performance associated with the progression of dementia and the degree of effectiveness of home based balance training in early stages of the disease on balance performance, risks of falls and quality of life in people with Alzheimer’s disease and their families.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28315 0
Address 28315 0
Country 28315 0
Phone 28315 0
Fax 28315 0
Email 28315 0
Contact person for public queries
Name 11472 0
Plaiwan Suttanon
Address 11472 0
Preventive and public health division, National Ageing Research Institute (NARI), 34-54 Poplar Rd, PO Box 31, Parkville Victoria 3052
Country 11472 0
Australia
Phone 11472 0
+61 3 8387 2383
Fax 11472 0
+61 3 8387 2153
Email 11472 0
p.suttanon@nari.unimelb.edu.au
Contact person for scientific queries
Name 2400 0
Keith Hill
Address 2400 0
Preventive and public health division, National Ageing Research Institute (NARI), 34-54 Poplar Rd, PO Box 31, Parkville Victoria 3052
Country 2400 0
Australia
Phone 2400 0
+61 3 8387 2626
Fax 2400 0
+61 3 8387 2153
Email 2400 0
k.hill@nari.unimelb.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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