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Trial registered on ANZCTR


Registration number
ACTRN12605000136606
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
12/08/2005
Date last updated
8/08/2019
Date data sharing statement initially provided
8/08/2019
Date results information initially provided
8/08/2019
Type of registration
Prospectively 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
Linked study record

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 Fitness for the Ageing Brain Study (FABS) RCT was conducted between 2004-2006 in older adults with subjective cognitive decline (SCD), with or without mild cognitive impairment (MCI) with assessments at 0, 6, 12 and 18 months. The intervention group had a 6-month home-based physical activity (PA) intervention.
In Stage 1 of the long-term follow-up we will evaluate the long-term effects of that PA program on PA, cognition, function and health for this cohort after 10-15 years with a repeat of the assessments from the original trial. There is no active intervention in this period.
In Stage 2 we proposed to access information from the WA Health Department data linkage service for those not withdrawing from the original study and those opting out of the follow-up interview.
Both the Intervention and control group will be invited to participate in the follow-up Study.
Intervention code [1] 104 0
None
Comparator / control treatment
The follow-up process for the control group will be the same as the Intervention group.
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 and after a further 10-15 years 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 and after a further 10-15 years of follow-up..
Secondary outcome [3] 373656 0
Morbidity data from the Western Australia hospital morbidity data via the WA Data Linkage Branch.
Timepoint [3] 373656 0
10-15 years post recruitment to the original trial.
Secondary outcome [4] 373657 0
Mortality data (number and cause of mortality) collected from the mortality register via data linkage by the WA data linkage Branch.
Timepoint [4] 373657 0
10-15 years post recruitment to the study.
Secondary outcome [5] 373658 0
Health service usage assessed from the Aged Care Assessment Data and the Home and Community Care Data via the WA Data Linkage branch.
Timepoint [5] 373658 0
10-15 years post recruitment into the study.

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?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For the original trial the participation of 84 volunteers in each of the two groups (total=168) at baseline resulted in power of 90% with alpha set at 0.05. We estimated a drop out rate of 20%, which led to the recruitment of 170 participants with power set at 80% (85 randomly allocated to each group).
The primary analysis was based on intention-to treat (ITT) using the multiple imputation (MI) procedure of SAS. Each imputed dataset was analysed using a mixed effect model with repeated measures, and parameter estimates were then averaged across datasets. The ITT analysis was then followed by a complete case (CC) analysis, where only participants with valid data at all time points were included in the analysis.

Repeated measures procedure was used in an analysis of covariance (ANCOVA) in both the ITT and CC analyses. For ITT data, a mixed model with repeated measures in SAS was used while for CC data, a GLM for repeated measures ANCOVA in SPSS was used. Covariates such as age, sex, education level, marital status and premorbid IQ were included in the multivariate model. In addition, data from each follow-up time point were subtracted from baseline for each participant to examine the magnitude of change over time. Repeated measures ANCOVA analyses were applied to evaluate change from baseline in the same manner described above.
For the Follow-up study frequency counts and chi square analyses will be used to determine the distribution of subjects for demographic data; and categorical data such as mortality, morbidity, health conditions and health service utilisation. Changes over time and between group differences in cognition, health, PA, everyday function, QoL and health service utilisation and attributed costs will be analysed with longitudinal mixed-effects regression models with maximum restricted likelihood estimation to accommodate missing observations without deletion of cases. Multiple regression models will be used to identify factors associated with cognitive decline and other outcomes.


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

Funding & Sponsors
Funding source category [1] 311 0
Government body
Name [1] 311 0
NHMRC
Address [1] 311 0
National Health and Medical Research Council (NHMRC)
GPO Box 1421
Canberra ACT 2601.
16 Marcus Clarke St,
Canberra ACT 2601
1300 064 672 in Australia
+61 2 6217 9000
nhmrc@nhmrc.gov.au
Country [1] 311 0
Australia
Primary sponsor type
Individual
Name
Nicola Lautenschlager
Address
Department of Psychiatry
Melbourne Medical School
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
RMH Royal Park Campus
Ground Floor, Building 5
34-54 Poplar Road, Parkville. 3052
Victoria.
T: +61-3-8344 5509
Country
Australia
Secondary sponsor category [1] 242 0
None
Name [1] 242 0
Address [1] 242 0
Country [1] 242 0
Other collaborator category [1] 280902 0
Individual
Name [1] 280902 0
Kathryn Ellis
Address [1] 280902 0
Department of Psychiatry
Melbourne Medical School
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
RMH Royal Park Campus
Ground Floor, Building 5
34-54 Poplar Road, Parkville. 3052
Victoria.
T: +61-3-8344 5509
Country [1] 280902 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304043 0
West Australian Department of Health Royal Perth Hospital
Ethics committee address [1] 304043 0
Ethics Office Level 5 Colonial House, Royal Perth Hospital, GPO Box X2213 Perth WA 6001
Tel (08) 9224 2292 | Fax (08) 9224 3688 | Email rph.hrec@health.wa.gov.au
Ethics committee country [1] 304043 0
Australia
Date submitted for ethics approval [1] 304043 0
03/02/2015
Approval date [1] 304043 0
18/03/2015
Ethics approval number [1] 304043 0
HREC Reference: REG 15-001
Ethics committee name [2] 304044 0
West Australian Department of Health Royal Perth Hospital
Ethics committee address [2] 304044 0
Level 2 Kirkman House, Royal Perth Hospital, GPO Box X2213 Perth WA 6847 Telephone: (08) 9224 2260 / (08) 9224 2292 Email: EMHS.REG@health.wa.gov.au
Ethics committee country [2] 304044 0
Australia
Date submitted for ethics approval [2] 304044 0
15/03/2018
Approval date [2] 304044 0
16/03/2018
Ethics approval number [2] 304044 0
EC 00207
Ethics committee name [3] 304045 0
West Australian Department of Health Royal Perth Hospital
Ethics committee address [3] 304045 0
Level 2 Kirkman House, Royal Perth Hospital, GPO Box X2213 Perth WA 6847 Telephone: (08) 9224 2260 / (08) 9224 2292 Email: EMHS.REG@health.wa.gov.au
Ethics committee country [3] 304045 0
Australia
Date submitted for ethics approval [3] 304045 0
24/07/2018
Approval date [3] 304045 0
23/10/2018
Ethics approval number [3] 304045 0
REG Number: 2005-001- EC 00207
Ethics committee name [4] 304046 0
West Australian Department of Health
Ethics committee address [4] 304046 0
DOH WA Human Research Ethics Committee
Level 1, C Block
189 Royal Street
EAST PERTH WA 6060
Ethics committee country [4] 304046 0
Australia
Date submitted for ethics approval [4] 304046 0
28/09/2018
Approval date [4] 304046 0
10/10/2018
Ethics approval number [4] 304046 0
DOH HREC # - 2018/24

Summary
Brief summary
Aims: To conduct a first-ever long-term (10-15 years) follow-up of individuals at risk of Alzheimer’s disease (AD) who participated in a 6-month physical activity intervention versus usual-care to asses the effects on cognition, mental and physical health, and quality of life.

Hypothesis: We hypothesise that the group who undertook the physical activity intervention will have better mental and physical outcomes and a lower rates of Alzheimer’s disease and lower use of health services.

Methods: Individuals recruited into the original trial were re-contacted and invited to take part in this follow-up. In Stage 1 of the Follow-up study invitations were posted with 69 re-interviewed and data collected. In Stage 2 we propose to access information from the WA Department of Health data linkage service for those not withdrawing from the original study and those opting out of the follow-up interview to obtain information from several linked health agency databases.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35457 0
Prof Nicola Lautenschlager
Address 35457 0
Department of Psychiatry
Melbourne Medical School
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
RMH Royal Park Campus
Ground Floor, Building 5
34-54 Poplar Road, Parkville. 3052
Victoria.
Country 35457 0
Australia
Phone 35457 0
+61 3 8344 5509
Fax 35457 0
Email 35457 0
nicolatl@unimelb.edu.au
Contact person for public queries
Name 9293 0
Prof Nicola Lautenschlager
Address 9293 0
Department of Psychiatry
Melbourne Medical School
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
RMH Royal Park Campus
Ground Floor, Building 5
34-54 Poplar Road, Parkville. 3052
Victoria.
Country 9293 0
Australia
Phone 9293 0
+61 3 8344 5509
Fax 9293 0
Email 9293 0
nicolatl@unimelb.edu.au
Contact person for scientific queries
Name 221 0
A/Prof Kay Cox
Address 221 0
Medical School (RPH)
University of Western Australia
GPO Box X2213 Perth
WA 6847
Country 221 0
Australia
Phone 221 0
+61 8 92240237
Fax 221 0
Email 221 0
kay.cox@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The participants have only consented to their data being used for the FABS and the FABS Follow-Up Trial and any sharing of data would need new ethics approval and additional consent.
The current researchers will still be actively using the data for several more years.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 3734 0
Lautenschlager NT, Cox KL, Flicker L, Foster JK, van Bockxmeer F, Xiao J, Greenop KR, Almeida OP. Effect of Physical Activity on Cognitive Function in Older Adults at Risk for Alzheimer’s Disease: A Randomized Trial. Journal of the American Medical Association 2008; 300(9):1027-37.
Attachments [1] 3734 0
Publication date and citation/details [2] 3735 0
Cox Kay L, Flicker Leon, Almeida Osvaldo P., Xiao Jianguo, Greenop Kathryn R., Hendriks Jacqueline, Phillips Michael, Lautenschlager Nicola T. The FABS Trial: A randomised control trial of the effects of a 6-month physical activity intervention on adherence and long-term physical activity and self-efficacy in older adults with memory complaints. Prev Med 2013, 57:824-830.
Attachments [2] 3735 0
Publication date and citation/details [3] 3736 0
Kathryn R. Bonney; Osvaldo P. Almeida; Flicker; Kay Cox; Jonathan K. Foster; Frank M. van Bockxmeer; Nicola T. Lautenschlager. Reduced awareness of executive dysfunction in Alzheimer’s disease is associated with increased carer burden. International Psychogeriatrics 2007;19:1173-1175. DOI: 10.1017/S1041610207005947.
Attachments [3] 3736 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary