Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000066785
Ethics application status
Not yet submitted
Date submitted
11/01/2013
Date registered
17/01/2013
Date last updated
3/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cognitive training and physical activity on everyday executive function in older adults.
Scientific title
The effect of cognitive training and physical activity on everyday executive function in older adults.
Secondary ID [1] 281380 0
None.
Universal Trial Number (UTN)
U1111-1135-7580
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Executive function 287609 0
Condition category
Condition code
Neurological 287941 287941 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. Cognitive training. This will be conducted in small groups by a research assistant, 1 hour sessions 3x per week for 4 weeks. It will involve tasks dedicated to executive function training, especially as it relates to driving ability. Most tasks will be computer-based. Goal: To provide training and strategies that focus on executive control of movement.
Arm 2. Physical activity. This will be conducted in small groups by a research assistant, 1 hour sessions 3x per week for 4 weeks. It will involved Jazzercise, a dance-based physical activity program specifically tailored to this age-group, and designed to be cognitively challenging exercise (e.g., remembering patterns and steps, pattern changes etc).
Intervention code [1] 285858 0
Lifestyle
Comparator / control treatment
Arm 3 in this study is a no treatment control group.
Control group
Active

Outcomes
Primary outcome [1] 288154 0
Colour-choice reaction-time task
Timepoint [1] 288154 0
At pre-intervention and post-intervention (4 weeks)
Secondary outcome [1] 299520 0
Useful field of view test (UFOV). This is a measure of the extent to which individuals are capable of extracting visual information in a given moment without movement of the eyes or head, as an indicator of driving skill.
Timepoint [1] 299520 0
At pre-intervention and post-intervention (4 weeks)
Secondary outcome [2] 299521 0
Forced Expiratory Volume. This measures lung capacity to examine relative physiological effects of the interventions. It is measured using a device called a spirometer.
Timepoint [2] 299521 0
At pre-intervention and post-intervention (4 weeks)
Secondary outcome [3] 299522 0
Expectations of Ageing. This is a questionnaire measuring expectations regarding cognitive and physical health to examine relative changes across groups (ERA-12, Sarkisian et al, 2005).
Timepoint [3] 299522 0
At pre-intervention and post-intervention (4 weeks)

Eligibility
Key inclusion criteria
1.Age 70-80 years
2.Able to perform moderate intensity physical activity without using walking devices
Minimum age
70 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Not currently participating in any dance/aerobics
2. Not currently doing any brain training

3. Medical history. No:

a) insulin-dependent diabetes;
b) uncontrolled hypertension;
c) liver or kidney failure;
d) significant lung disease;
e) a history of alcoholism or drug abuse;
f) any heart problems which could limit your functions like cardiac failure;
g) heart disease;
h) significant visual impairment;
i) significant hearing loss;
j) cancer;
k) recent fracture;
l) uncontrolled seizures / epilepsy;
m) regular use of wheelchair;
n) undergoing current rehabilitation;
o) current fainting or dizzy spells;
p) sudden loss of coordination;
q) disabilities that impair your day-to-day living;
r) multiple sclerosis;
s) head injury;
t) brain swelling or infection;
u) focal brain disorders, brain tumour or brain surgery;
v) currently taking beta blockers or psychotropic medicine;
w) using medication for rheumatoid arthritis or psoriasis;
x) a diagnosis of Parkinsons disease;
y) diagnosis of dementia, or Alzheimer's disease;
z) living in or on waiting list for a nursing home;
aa) stroke resulting in significant motor or cognitive disabilities;
bb) currently being treated for any major condition or illness.

4. Using the MMSE, a cut-off score of 21 will be used to identify people with a suspected cognitive impairment. These participants will be excluded from participation in the trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Information forms about the project will be distributed to a retirement village. These information sheets will include contact details of researchers for those who wish to participate in the study. Once participants have indicated their interest, provided signed consent and found eligible for the trial according to inclusion and exclusion criteria, they will be randomly allocated to one of three conditions by an independent researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation). After administration of the baseline measures and providing consent to participate, each individual will be randomly assigned to one of the three conditions according to their sex. This stratification to condition will help to ensure approximately equal numbers of males and females in each group.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 286302 0
Government body
Name [1] 286302 0
ARC Centre of Excellence
Country [1] 286302 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
Bldg 62 Eggleston Rd
THE AUSTRALIAN NATIONAL UNIVERSITY
ACT 0200
Country
Australia
Secondary sponsor category [1] 284983 0
None
Name [1] 284983 0
Address [1] 284983 0
Country [1] 284983 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288237 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 288237 0
Ethics committee country [1] 288237 0
Australia
Date submitted for ethics approval [1] 288237 0
16/11/2012
Approval date [1] 288237 0
Ethics approval number [1] 288237 0
The Australian National University Human Research Ethics Committee Protocol number 2012/322.

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

Contacts
Principal investigator
Name 34818 0
Prof Kaarin Anstey
Address 34818 0
Bldg 62 Eggleston Rd
THE AUSTRALIAN NATIONAL UNIVERSITY
ACT 0200
Country 34818 0
Australia
Phone 34818 0
+61 2 6125 8410
Fax 34818 0
Email 34818 0
[email protected]
Contact person for public queries
Name 18065 0
Kaarin Anstey
Address 18065 0
Bldg 62 Eggleston Rd
THE AUSTRALIAN NATIONAL UNIVERSITY
ACT 0200
Country 18065 0
Australia
Phone 18065 0
+61 2 6125 8410
Fax 18065 0
Email 18065 0
[email protected]
Contact person for scientific queries
Name 8993 0
Kaarin Anstey
Address 8993 0
Bldg 62 Eggleston Rd
THE AUSTRALIAN NATIONAL UNIVERSITY
ACT 0200
Country 8993 0
Australia
Phone 8993 0
+61 2 6125 8410
Fax 8993 0
Email 8993 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.