Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000151437
Ethics application status
Approved
Date submitted
28/02/2007
Date registered
1/03/2007
Date last updated
1/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fit Bodies, Fine Minds: Physical activity and cognitive training for cognition in older adults
Scientific title
The role of physical activity and cognitive training in improving the cognitive performance and functional abilities of older adults
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Memory 1646 0
Executive functioning 1647 0
Mental speed 1648 0
Aerobic fitness 1649 0
Functional strength 1650 0
Psychological well-being 1651 0
Condition category
Condition code
Mental Health 1757 1757 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise, Exercise + Cognitive Training, No-treatment Control. Non-demented, community-dwelling older adults.

Exercise: 16 week program, 3 (60min) sessions per week, aerobic and strength training.

Exercise + Cognitive Training: 16 week program, 2 (60min) exercise sessions per week including aerobic and strength training, 1 (60min) cognitive training session per week covering memory, executive functioning, and mental speed.
Intervention code [1] 1625 0
Treatment: Other
Comparator / control treatment
Control: no treatment.
Control group
Active

Outcomes
Primary outcome [1] 2451 0
Memory: Logical Memory, Digit Span.
Timepoint [1] 2451 0
Baseline, Post-test (16-weeks), 6-month follow-up
Primary outcome [2] 2452 0
Executive Functioning: Matrix Reasoning, D-KEFS Sorting Test, Californian Older Adults Stroop Test.
Timepoint [2] 2452 0
Baseline, Post-test (16-weeks), 6-month follow-up.
Primary outcome [3] 2453 0
Mental Speed: Symbol Digit Modalities Test, Simple Reaction Time, Choice Reaction Time.
Timepoint [3] 2453 0
Baseline, Post-test (16-weeks), 6-month follow-up.
Primary outcome [4] 2454 0
Fitness: Six-Minute Walk test, Submax, Chair Stand, Arm Curl.
Timepoint [4] 2454 0
Baseline, post-test (16-weeks), 6-month follow-up
Secondary outcome [1] 4217 0
Psychological Well-being: Memory Complaint Questionnaire, SF-36, Health-Related Hardiness Scale, Goldberg Anxiety & Depression Scale.
Timepoint [1] 4217 0
Baseline, Post-test (16-weeks), 6-month follow-up.
Secondary outcome [2] 4218 0
Feasability measures: adherence (recorded at each training session), compliance (recorded at each training session), satisfaction with program (qualitative - assessed at 16-weeks).
Timepoint [2] 4218 0

Eligibility
Key inclusion criteria
Current physical activity: less than 60 minutes per weekAvailability: living within 10km of the University of Queensland and available during the dayGender: men and women.
Minimum age
65 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia Screening: score less than 21 on Telephone Interview of Cognitive Status (TICS)Health: Major health problem impeding physical activity and no permission from General Practitioner.

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)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
29/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1908 0
Government body
Name [1] 1908 0
Australian Postgraduate Award
Country [1] 1908 0
Australia
Funding source category [2] 1909 0
Government body
Name [2] 1909 0
NHMRC program grant in physical activity and health
Country [2] 1909 0
Australia
Funding source category [3] 1910 0
University
Name [3] 1910 0
University of Queensland, School of Human Movement Studies (Owen, Bauman and Brown; #301200).
Country [3] 1910 0
Australia
Primary sponsor type
Individual
Name
Siobhan O'Dwyer
Address
Country
Secondary sponsor category [1] 1722 0
Individual
Name [1] 1722 0
Professor Wendy Brown
Address [1] 1722 0
Country [1] 1722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3554 0
School of Human Movement Studies,University of Queensland
Ethics committee address [1] 3554 0
Ethics committee country [1] 3554 0
Australia
Date submitted for ethics approval [1] 3554 0
Approval date [1] 3554 0
23/03/2006
Ethics approval number [1] 3554 0
HMS06/2303

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

Contacts
Principal investigator
Name 27559 0
Address 27559 0
Country 27559 0
Phone 27559 0
Fax 27559 0
Email 27559 0
Contact person for public queries
Name 10814 0
Siobhan O'Dwyer
Address 10814 0
School of Human Movement Studies
University of Queensland
Brisbane 4072
Country 10814 0
Australia
Phone 10814 0
+61 7 33656103
Fax 10814 0
Email 10814 0
sodwyer@hms.uq.edu.au
Contact person for scientific queries
Name 1742 0
Siobhan O'Dwyer
Address 1742 0
School of Human Movement Studies
University of Queensland
Brisbane 4072
Country 1742 0
Australia
Phone 1742 0
+61 7 33656103
Fax 1742 0
Email 1742 0
sodwyer@hms.uq.edu.au

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.