Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000556347
Ethics application status
Approved
Date submitted
13/10/2008
Date registered
7/11/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting Healthy Ageing with Cognitive Exercise
Scientific title
A randomised trial of cognitive activity and measurement of cognitive functioning over time for older adults with mild cognitive impairment.
Universal Trial Number (UTN)
Trial acronym
PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild cognitive impairment 3824 0
cognitive decline 3825 0
Condition category
Condition code
Mental Health 4011 4011 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation in 2 x 90 minute cognitive activity sessions per week across 5 weeks. Sessions run with groups of participants (Approximately 8 people per group) with a facilitator running each session and pencil and paper activities completed. The pencil and paper activities include memory tasks, measures of attention, puzzles and word games.
Intervention code [1] 3546 0
Behaviour
Intervention code [2] 3547 0
Rehabilitation
Comparator / control treatment
Participation in 2 x 90 minute education (control) sessions per week across 5 weeks. Sessions run with groups of participants (Approximately 8 people per group) with a facilitator running each session covering topics relevant to healthy ageing. Topics include physical activity and nutrition, depression, ways to stay healthy in retirement.
Control group
Active

Outcomes
Primary outcome [1] 4911 0
Cambridge Cognitive Examination of the Elderly, Cognitive Scale Revised (CAMCOG-R). The primary outcome is change in CAMCOG-R scores from baseline.
Timepoint [1] 4911 0
Baseline, post intervention, 12 and 24 months.
Secondary outcome [1] 8294 0
California Verbal Learning Test - II (CVLT-II). This test measures memory.
Timepoint [1] 8294 0
Baseline, post intervention, 12 and 24 months.

Eligibility
Key inclusion criteria
- Diagnosis of Mild Cognitive Impairment (MCI)
- Willing to travel to study site
- Fluent in written and spoken English
- Mini Mental State Examination (MMSE) score >23
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis of dementia according to the International Classification of Diseases - Revision 10 (ICD-10);
- Diagnosis of current psychiatric disorder;
- Current history of hazardous alcohol consumption;
- Severe visual or hearing impairment

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were randomly allocated to either the cognitive activity or the education intervention according to a random list of numbers generated by computer. Randomisation is carried out and maintained by an independent academic not directly involved in the interventions or assessments.
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
Active, not recruiting
Date of first participant enrolment
Anticipated
18/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4005 0
Other Collaborative groups
Name [1] 4005 0
Centre for Excellence in Alzheimer's Disease Research and Care
Country [1] 4005 0
Australia
Funding source category [2] 4006 0
Government body
Name [2] 4006 0
National Health and Medical Research Council (NHMRC)
Country [2] 4006 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
M573, University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 3598 0
Other Collaborative groups
Name [1] 3598 0
Centre of Excellence for Alzheimer's Disease Research and Care
Address [1] 3598 0
Building 17
Edith Cowan University
270 Joondalup Drive
Joondalup
Western Australia 6027
Country [1] 3598 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6084 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 6084 0
Royal Perth Hospital
GPO Box: X2213
Perth, WA 6847
Ethics committee country [1] 6084 0
Australia
Date submitted for ethics approval [1] 6084 0
Approval date [1] 6084 0
09/11/2006
Ethics approval number [1] 6084 0
EC 2007/051

Summary
Brief summary
The primary focus of this research is to determine whether a structured program of cognitive activity (CA) can delay progression of cognitive decline amongst older adults with mild cognitive impairment (MCI). It is hypothesised that older adults with MCI randomised to an intervention of CA will experience less cognitive decline than older adults randomised to a non-specific educational program (as measured by the CAMCOG) over a twelve month follow-up period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29033 0
Address 29033 0
Country 29033 0
Phone 29033 0
Fax 29033 0
Email 29033 0
Contact person for public queries
Name 12190 0
Mandy Vidovich
Address 12190 0
WACHA
Level 6 Ainslie House
48 Murray Street
Perth WA 6009
Country 12190 0
Australia
Phone 12190 0
08 9224 2855
Fax 12190 0
08 9224 8009
Email 12190 0
[email protected]
Contact person for scientific queries
Name 3118 0
Mandy Vidovich
Address 3118 0
WACHA
Level 6 Ainslie House
48 Murray Street
Perth WA 6009
Country 3118 0
Australia
Phone 3118 0
08 9224 2855
Fax 3118 0
08 9224 8009
Email 3118 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.