Trial registered on ANZCTR


Trial ID
ACTRN12605000136606
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
12/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised clinical trial of physical activity for the treatment of older adults with mild cognitive impairment
Scientific 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.
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment
224 0
Subjective Memory Complaints 225 0
Alzheimer's Disease 226 0
Condition category
Condition code
Neurological 254 254 0 0
Dementias
Neurological 255 255 0 0
Neurodegenerative diseases
Neurological 256 256 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active group receive a 6-month physical activity program.
Intervention code [1] 104 0
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.
Control group
Active

Outcomes
Primary outcome [1] 302 0
Cognitive decline.
Timepoint [1] 302 0
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] 662 0
For participants with Alzheimer's disease the secondary outcome: quality of life.
Timepoint [1] 662 0
Measured at 6 months after enrolment.
Secondary outcome [2] 663 0
For participants with Mild Cognitive impairment the secondary outcome: diagnosis of dementia and quality of life.
Timepoint [2] 663 0
Measured 18 months after enrolment.

Eligibility
Key inclusion criteria
Diagnosis of Mild Cognitive Impairment, subjective Memoery Complaints or mild to moderate Alzheimer's disease.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical history of stroke, unstable or life threatening illness.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes are used.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
22/04/2004
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
168
Actual sample size
Recruitment status
Closed: follow-up continuing
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 311 0
Government body
Name [1] 311 0
NHMRC
Address [1] 311 0
Country [1] 311 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 242 0
Charities/Societies/Foundations
Name [1] 242 0
Rotary Australia
Address [1] 242 0
Country [1] 242 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35457 0
Address 35457 0
Country 35457 0
Phone 35457 0
Fax 35457 0
Email 35457 0
Contact person for public queries
Name 9293 0
A/Prof N Lautenschlager
Address 9293 0
School of Psychiatry and Clinical Neurosciences
University of Western Australia
M 573
35 Stirling Highway
Crawley WA 6009
Country 9293 0
Australia
Phone 9293 0
+61 8 92242855
Fax 9293 0
Email 9293 0
nicolal@cyllene.uwa.edu.au
Contact person for scientific queries
Name 221 0
A/Prof N Lautenschlager
Address 221 0
School of Psychiatry and Clinical Neurosciences
University of Western Australia
M 573
35 Stirling Highway
Crawley WA 6009
Country 221 0
Australia
Phone 221 0
+61 8 92242855
Fax 221 0
Email 221 0
nicolal@cyllene.uwa.edu.au