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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
000112
ACTR Number:
ACTRN12605000136606
Trial Status:
Registered
Date Submitted:
2/08/2005
Date Registered:
12/08/2005
Page 1
Public title:
A randomised clinical trial of physical activity for the treatment of older adults with mild cognitive impairment
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Reason:
ANZCTR registration title:
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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Secondary ID:
UTN:
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Trial acronym:
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Page 2
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment
Subjective Memory Complaints
Alzheimer's Disease
Condition category:
Condition code:
Neurological
Dementias
Neurological
Neurodegenerative diseases
Neurological
Alzheimer's disease
Page 3
Description of intervention(s) / exposure:
The active group receive a 6-month physical activity program.
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Intervention code:
None
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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Page 4
Primary outcome:
Cognitive decline.
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.
Secondary outcome 1:
For participants with Alzheimer's disease the secondary outcome: quality of life.
Timepoint:
Measured at 6 months after enrolment.
Secondary outcome 2:
For participants with Mild Cognitive impairment the secondary outcome: diagnosis of dementia and quality of life.
Timepoint:
Measured 18 months after enrolment.
Page 5
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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Page 6
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:
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Assignment:
Parallel
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Other design features (specify):
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Type of endpoint(s):
Efficacy
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Page 7
Phase
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Anticipated or actual date of first participant enrolement:
22/04/2004
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Target sample size:
168
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Recruitment status:
Closed: follow-up continuing
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Page 8
Funding source:
Government funding body e.g. Australian Research Council
Name:
NHMRC
Address:
Country:
Australia
Primary sponsor:
Government funding body e.g. Department of Health
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Name:
NHMRC
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Address:
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Country:
Australia
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Secondary sponsor:
Charities/Societies/Foundations
Name:
Rotary Australia
Address:
Country:
Australia
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
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Ethics Committee:
Countries of recruitment:
Australia
Brief summary:
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Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
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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Fax:
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Email:
nicolal@cyllene.uwa.edu.au
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Contact person for scientific queries
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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+61 8 92242855
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Email:
nicolal@cyllene.uwa.edu.au
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