Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000755235
Ethics application status
Approved
Date submitted
27/08/2009
Date registered
1/09/2009
Date last updated
6/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fitness for the Ageing Brain Study II
Scientific title
A multicentre randomised clinical trial to evaluate the effect of physical activity on cognitive function in patients with Alzheimer’s disease (Fitness for the Ageing Brain Study II – FABS II)
Secondary ID [1] 262250 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
FABS II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease (AD) 4889 0
Condition category
Condition code
Neurological 237244 237244 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This 6-month study comprised a 24-week individualised home-based physical activity intervention (= 150 minutes per week moderate intensity physical activity with a focus on walking). The participants were asked to complete the sessions as 3 x 50 minutes per week. They were offered a shorter session time of 30 minutes ( ie 5 x 30 minutes/week) if they indicated that they would have difficulty complying with longer session durations. Participants received a 1 hour workshop session one on one with an exercise physiologist at baseline. They received their own take-home resource manual containing their individualised exercise program information about exercise and safety and a behavioural education package. The material in the manual was explained to the participants during the workshop. The exercise program was carried out at home. They had the option of completing this with a carer or another person. The participants received scheduled 15-minute follow-up telephone calls (weeks 2, 4, 8, 14, 20) from the exercise physiologist. The program and scheduled worksheets in the intervention program were discussed. Five newsletters containing exercise information and material to enhance exercise compliance were also sent out to participants at regular intervals (weeks 3, 7, 11, 15) during the intervention phase. After 12 weeks the participants were sent a pedometer to wear during the exercise sessions to provide feedback and motivation for a 4 week period.
Intervention code [1] 236677 0
Treatment: Other
Comparator / control treatment
Usual care for 24 weeks. All participants and carers received educational material on AD and recommendations for a healthy lifestyle (other than physical activity). Participants were contacted by telephone at the same frequency as the intervention group. This was to ensure that the control and intervention group had similar treatment except for the actual intervention. Conversation for this group was limited to their general health and did not include discussion about physical activity.
Control group
Active

Outcomes
Primary outcome [1] 238057 0
Cognitive function. This was measured using the Alzheimer's Disease Assessment Scale - cognitive section (ADAS-cog).
Timepoint [1] 238057 0
6 months following randomisation
Secondary outcome [1] 242244 0
Behavioural and Psychological Symptoms (BPSD). This was measured using the Neuropsychiatric Inventory.
Timepoint [1] 242244 0
6 months following randomisation
Secondary outcome [2] 242245 0
Functional level. This was assessed using the Step Test for balance, the Timed-Up-and-Go Test for agility, the Sit-to-Stand Test for leg strength, Hand Grip Strength for arm strength and the 2-minute Walk Test for aerobic endurance. Function was also assessed using the Instrumental Activities of Daily Living Scale and the Katz Activities of Daily Living Scale.
Timepoint [2] 242245 0
6 months following randomisation
Secondary outcome [3] 242246 0
Quality of life of participant and carer. This was assessed using the Quality of Life in AD measure.
Timepoint [3] 242246 0
6 months following randomisation
Secondary outcome [4] 244895 0
Carer burden. This was measured using the Zarit Burden Interview.
Timepoint [4] 244895 0
6 months following randomisation

Eligibility
Key inclusion criteria
Diagnosis of mild to moderate AD (Mini-Mental State Examination (MMSE) score greater and equal 10/30)
Contact with carer more than 10 hours per week who is willing to participate in trial
Community-dwelling
No unstable or lifethreatening medical condition
Geriatric Depression Scale (GDS) score 7 or less (= no significant depression)
Needs to understand spoken and written English
Needs to be able to attend visits to the National Ageing Research Institute (NARI)
No severe visual or hearing impairment
No presence of significant aphasia
No history of chronic alcohol abuse within the past 5 years
No medical condition that contraindicates physcial activity
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable or lifethreatening medical condition
GDS score greater/ equal than 7 (= significant depression)
Cannot understand spoken and written English
Cannot attend visits to NARI
Severe visual or hearing impairment
Presence of significant aphasia
History of chronic alcohol abuse within the past 5 years
Medical condition that contraindicates physcial activity

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)
A potential participant and his/her carer first underwent a telephone screening interview to initially determine eligibility. If both passed the phone screen, we obtained written permission to contact the participant's General Practitioner (GP) to request his/her medical history (including Alzheimer's disease diagnosis). If the participant's GP was happy for his/her patient to participate and, upon review of the records by the project's medical team, the participant had no medical conditions that excluded him/her from participating, the participant and his/her carer were invited to a baseline assessment. After the assessment was completed, the treatment was randomly allocated. Allocation was concealed using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each of the three study sites was given 100 sealed opaque envelopes (numbered 1-100 and used in that order). After the participant completed his/her baseline assessment, a research assistant opened one envelope. Inside the envelope there was either the letter A (physical activity group) or B (control group). Ryan, P (1998). sxd1: Random allocation of treatments in blocks. Stata Technical Bulletin 41: 43-46.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2009
Actual
31/08/2009
Date of last participant enrolment
Anticipated
Actual
29/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237368 0
Government body
Name [1] 237368 0
National Health and Medical Research Council
Country [1] 237368 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Melbourne Research Office
Level 5, Allan Gilbert Building
The University of Melbourne, VIC
3010
Country
Australia
Secondary sponsor category [1] 236864 0
Other
Name [1] 236864 0
National Ageing Research Institute
Address [1] 236864 0
34-54 Poplar Road
Parkville, VIC
3052
Country [1] 236864 0
Australia
Other collaborator category [1] 780 0
University
Name [1] 780 0
University of Western Australia
Address [1] 780 0
School of Medicine and Pharmacology (Royal Perth Hospital Unit)
GPO Box X2213
Perth. WA 6001
Country [1] 780 0
Australia
Other collaborator category [2] 781 0
University
Name [2] 781 0
The University of Queensland
Address [2] 781 0
Discipline of Psychiatry
University of Queensland
K Floor
Mental Health Centre (Building 21)
Royal Brisbane & Women's Hospital
Bowen Bridge Road
Herston, QLD 4006
Country [2] 781 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239493 0
Melbourne Health Mental Health Research and Ethics Committee
Ethics committee address [1] 239493 0
Office for Research
Level 6 East, Main Building
Grattan Street
The Royal Melbourne Hospital, Parkville VIC 3050
Ethics committee country [1] 239493 0
Australia
Date submitted for ethics approval [1] 239493 0
Approval date [1] 239493 0
25/02/2009
Ethics approval number [1] 239493 0
2009.604
Ethics committee name [2] 243679 0
Royal Perth Hospital Ethics Committee
Ethics committee address [2] 243679 0
Room 4112 Level 4
Kirkman House
Royal Perth Hospital
University of Western Australia
Perth, WA 6001
Ethics committee country [2] 243679 0
Australia
Date submitted for ethics approval [2] 243679 0
Approval date [2] 243679 0
16/03/2009
Ethics approval number [2] 243679 0
EC 2009/011

Summary
Brief summary
The primary aim of this 3-site multicentre randomised controlled trial was to establish whether physical activity (PA) can decrease the rate of cognitive decline amongst patients with mild to moderate Alzheimer’s disease (AD). The main hypothesis was that participants with mild to moderate AD who were randomised to a program of PA will experience significantly less cognitive decline by the end of the intervention than participants with mild to moderate AD randomised to usual care. Previously, some of the researchers involved in this study successfully developed a PA program for participants with mild cognitive impairment (FABS) and tested this program in a pilot study with patients with mild to moderate AD.
Trial website
Trial related presentations / publications
NT Lautenschlager, K Cox, EV Cyarto: The influence of exercise on brain ageing and dementia. Biochimica et Biophysica Acta 2012;1822:474-481.

Cyarto, E.V., Cox, K.L., Almeida, O.P., Flicker, L., Ames, D. Byrne, G., Hill, K.D., Beer, C.D., LoGiudice, D., Appadurai, K., Irish, M,. Renehan, E., Lautenschlager, N.T. The Fitness for the Ageing Brain Study II (FABS II): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer’s disease. Trials 2010;Dec 10;11:120.

Cyarto, E.V., Irish, M., Cox, K., Almeida, O.P., Flicker, L., Ames, D., Hill, K., Byrne, G., Appadurai, K., Beer, C., LoGiudice, D., Renehan, E., Waddell, F., Hughes, K., Lautenschlager, N.T. Fitness for the Ageing Brain Study II: a multisite randomized controlled trial to determine the clinical benefits of physical activity for patients with mild-to-moderate Alzheimer’s Disease. Alzheimer’s & Dementia 2010;6 suppl 1:S584.
Public notes

Contacts
Principal investigator
Name 29675 0
Prof Nicola Lautenschlager
Address 29675 0
Academic Unit for Psychiatry of Old Age Normanby Unit, St. Vincent's Aged Psychiatry Service St. George's Campus, St. Vincent's Hospital 283 Cotham Road Kew, VIC 3101
Country 29675 0
Australia
Phone 29675 0
+61 3 9816 0485
Fax 29675 0
Email 29675 0
nicolatl@unimelb.edu.au
Contact person for public queries
Name 12922 0
Dr Elizabeth Cyarto
Address 12922 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital, Parkville, VIC 3050
Country 12922 0
Australia
Phone 12922 0
+61 3 8387 2332
Fax 12922 0
+61 3 9387 4030
Email 12922 0
e.cyarto@nari.unimelb.edu.au
Contact person for scientific queries
Name 3850 0
Prof Prof Nicola Lautenschlager
Address 3850 0
Academic Unit for Psychiatry of Old Age
Normanby Unit, St. Vincent's Aged Psychiatry Service
St. George's Campus, St. Vincent's Hospital
283 Cotham Road
Kew, VIC 3101
Country 3850 0
Australia
Phone 3850 0
+61 3 9816 0485
Fax 3850 0
Email 3850 0
nicolatl@unimelb.edu.au

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