Trial from ANZCTR


Trial ID ACTRN12605000136606
Trial Status: Registered
Date Submitted: 2/08/2005
Date Registered: 12/08/2005
Retrospectively registered

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Public title A randomised clinical trial of physical activity for the treatment of older adults with mild cognitive impairment
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomised clinical trial to evaluate the effect of physical activity on cognition and quality of life in the conditons subjective memory complaints, mild cognitive impairment and Alzheimer's disease.
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Mild Cognitive Impairment
224 0
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Subjective Memory Complaints 225 0
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Alzheimer's Disease 226 0
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Condition category: Condition code:
Neurological Dementias
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254 254 0 0
Neurological Neurodegenerative diseases
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Neurological Alzheimer's disease
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256 256 0 0

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Descriptions of intervention(s) / exposure The active group receive a 6-month physical activity program.
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Intervention Code:
None 104 0
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Comparator / control treatment The active and the control group receive educational material on cognitive impairment in older age and recommendations for a healthy lifestyle.
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Control group Active
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Primary Outcome: Cognitive decline. 302 0
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Timepoint: For participants with Alzheimer's disease the primary outcome will be measured 6 months after enrolment.
For participants with subjective memory complaints or mild cognitive impairment the primary outcome will be measured 18 months after enrolment.
302 0
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Secondary Outcome: For participants with Alzheimer's disease the secondary outcome: quality of life. 662 0
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Timepoint: Measured at 6 months after enrolment. 662 0
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Secondary Outcome: For participants with Mild Cognitive impairment the secondary outcome: diagnosis of dementia and quality of life. 663 0
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Timepoint: Measured 18 months after enrolment. 663 0
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Key inclusion criteria Diagnosis of Mild Cognitive Impairment, subjective Memoery Complaints or mild to moderate Alzheimer's disease.
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Minimum age Not stated
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Maximum age Not stated
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Clinical history of stroke, unstable or life threatening illness.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Sealed envelopes are used.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Randomisation occurred in blocks. Sequence generation was performed consecutively selecting one of the identical cards from the block.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 22/04/2004
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 168
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 311 0
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Name: NHMRC 311 0
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Address: 311 0
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Country: Australia 311 0
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Primary Sponsor Government body
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Name: NHMRC
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Country: Australia
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Secondary Sponsor: Charities/Societies/Foundations 242 0
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Name: Rotary Australia 242 0
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Address: 242 0
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Country: Australia 242 0
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Has the study received approval from at least one Ethics Committee? Yes
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Brief summary
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: A/Prof N Lautenschlager
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Address: School of Psychiatry and Clinical Neurosciences University of Western Australia M 573 35 Stirling Highway Crawley WA 6009
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Country: Australia
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Tel: +61 8 92242855
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Email: nicolal@cyllene.uwa.edu.au
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Contact person for scientific queries
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Name: A/Prof N Lautenschlager
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Address: School of Psychiatry and Clinical Neurosciences University of Western Australia M 573 35 Stirling Highway Crawley WA 6009
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Country: Australia
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Email: nicolal@cyllene.uwa.edu.au
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