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Trial registered on ANZCTR


Registration number
ACTRN12611000612910
Ethics application status
Approved
Date submitted
7/06/2011
Date registered
15/06/2011
Date last updated
10/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A physical activity intervention to delay the progression of cerebrovascular disease in older adults with mild memory problems
Scientific title
A randomised clinical trial of physical activity to delay the progression of cerebrovascular disease in older adults with memory complaints and mild cognitive impairment
Secondary ID [1] 262221 0
Nil
Universal Trial Number (UTN)
Trial acronym
AIBL Active
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment (MCI) 267915 0
Subjective Memory Complaints (SMC) 267916 0
Cerebrovascular disease 268081 0
Condition category
Condition code
Neurological 268230 268230 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention received, one week after the baseline assessment, a 60-min individual workshop. The workshop comprised two components, physical activity (PA) and behavioural intervention (BI) program. In the workshop the facilitator outlined the PA program, explained the activities, how often they were to be done, the intensity and how to record on their exercise diary. The strategies and worksheets designed to enhance adherence to the PA in the BI program were discussed. The PA program was individually tailored for each participant taking into account their PA preferences and health limitations. Physical activity was progressively increased over a period of 8 weeks until the target time spent and intensity was satisfactorily attained. Participants were advised to perform 150 min/week of moderate home-based PA and examples were given on how this could be achieved. Participants who already perform 150 min/week PA were encouraged to increase their PA to a new feasible level (the addition of approx 50 minutes/week). The supervised intervention period was 24 months. In the first 6 months, walking was recommended, however participants were able to select other activities taking into account any health problems or other limitations. Participants were encouraged to complete the PA as 3, 50-minute sessions a week or 5, 30-minute sessions a week. After the first 6 months, in order to maintain interest and motivation, the participants had their exercise adherence, fitness results and progress reviewed in a 15-minute session as part of the 6-month reassessment. Another 15-minute review took place at the time of their 12-month reassessment. They either continued with the same exercise type or switched ti other easily accessible aerobic activities.

Behavioural intervention: The BI program was based on the Stages of Change Model. This model, based on social cognitive theory (SCT) proposes that individuals move through five stages when they adopt a new behaviour: pre-contemplation, contemplation, preparation, action and maintenance. We identified each individual’s stage of PA behaviour and developed a program to move them onto the next stage. This approach was based on the development of self-efficacy (the belief that one has the ability to perform a task) to promote change. An increase in self-efficacy (SE) has been found to facilitate movement from the contemplation to the action/maintenance stage of exercise adoption. The BI program aimed to develop SE by promoting practical strategies to enhance both physical skills and self-management skills. Another key component of SCT is self-regulation. SCT purports that behaviour is changed through self efficacy and self-regulation strategies and not solely self efficacy. Self-regulation has been defined as personal regulation of goal directed behaviour or performance. In this study, as we aimed to maximise the adherence to the exercise for the 24-month intervention we also included the teaching and promotion of self-regulatory skills. The BI package was included in a resource manual given out and discussed at the first workshop. It contained information as well as worksheets for the participants to complete. In each 6-month period, one worksheet was completed per month. One additional worksheet were completed in the first and last month of each period.

SCT concepts were reinforced during telephone calls and via the newsletters. Six standardised and structured 15-min telephone calls were made to participants during the first 6 months. In the second and subsequent three 6-month periods, there were four telephone support calls. Newsletters, sent out at regular intervals, supplemented contact with the participants. In the first six months, five newsletters were sent. In each of the remaining 6-month periods, four newsletters were sent. Participants were given a PA calendar to complete and return to the research centre by reply paid post each month. Pedometers were given to the participants for the duration of the study and midway through each 6-month period they were asked to record their daily steps for four weeks whilst trying to reach a personalised target. These strategies combined met the recommendations for best practice for the maintenance of PA in the long-term.
Intervention code [1] 264616 0
Lifestyle
Intervention code [2] 266769 0
Behaviour
Intervention code [3] 266770 0
Prevention
Comparator / control treatment
The control group received a "usual care" information pack on various health issues, excluding physical activity. They had the same number of telephone calls and received the same number of newsletters as the intervention group. Conversation during the calls was limited to their general health and did not include discussion about physical activity. Each newsletter contained a profile of a research team member and general health information. At the completion of the study, control group participants were offered the opportunity to attend a physical activity workshop.

There was also a "healthy" control group consisting of up to 30 AIBL participants without SMC or MCI. These individuals underwent a baseline assessment only. They were not randomised to an AIBL Active study group and did not undergo follow-up assessments.
Control group
Active

Outcomes
Primary outcome [1] 266799 0
Progression of cerebrovascular disease (CVD) as measured by MRI
Timepoint [1] 266799 0
24 months following randomisation
Secondary outcome [1] 276414 0
Cognitive decline as measured by the Alzheimer's Disease Assessment Scale - cognitve section (ADAS-cog), Cognitive Dementia Rating scale, Memory Complaint Questionnaire and Standardised Mini Mental State Examination
Timepoint [1] 276414 0
6, 12 and 24 months following randomisation
Secondary outcome [2] 276415 0
Executive function as measured by the Wisconsin Card Sorting Task, Nback test, Trail Making Tests and Behaviour Rating Inventory of Executive Functioning
Timepoint [2] 276415 0
12 and 24 months following randomisation
Secondary outcome [3] 276416 0
Depression and anxiety and quality of life as measured by the Hospital Anxiety and Depression Scale and the SF-36
Timepoint [3] 276416 0
6, 12 and 24 months following randomisation
Secondary outcome [4] 276417 0
Plasma biomarker levels for CVD
Timepoint [4] 276417 0
24 months following randomisation
Secondary outcome [5] 276418 0
Functional level. This will be assessed using the Step Test for dynamic balance, the Timed-Up-and-Go Test for agility, the Sit-to-Stand Test for leg strength, hand grip strength, Six-minute Walk Test for aerobic endurance.
Timepoint [5] 276418 0
6, 12 and 24 months following randomisation
Secondary outcome [6] 276419 0
Fibrillar beta-amyloid as measured by PET Florbetapir
Timepoint [6] 276419 0
24 months following randomisation

Eligibility
Key inclusion criteria
Community dwelling
Diagnosis of SMC or MCI
Presence of at least one CVD risk factor
English Speaker
Willingness and ability to provide written informed consent
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Baseline Mini-Mental State Examination (MMSE) score < 24
Diagnosis of dementia
Unable to undergo MRI or PET scans
Geriatric Depression Scale (GDS-15) score > 6
Unstable or life threatening disease or illness that could lead to difficulty complying with the protocol
Medical condition that contraindicates physical activity
Severe visual or auditory impairment
History of chronic alcohol abuse within the past 5 years
Unable to attend the follow-up assessments

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)
Participants were recruited from those already enrolled in the Australian Imaging, Biomarkers and Lifestyle (AIBL) Flagship Study. The AIBL study is a multi-disciplinary prospective longitudinal study of ageing which follows 1112 older volunteers who live in Melbourne and Perth. The aim of the AIBL study is to identify the predictive value of biomarkers, cognitive variables and lifestyle factors for future progression to AD. Several members of the AIBL Active research team are investigators in the AIBL study. AIBL participants belong to 4 diagnostic categories - normal cognition, SMC, MCI and AD. For the Melbourne site, 241 fulfil the criteria for SMC and 84 for MCI.

A potential participant for AIBL Active was first identified by AIBL study staff using the inclusion/exclusion criteria. The person was sent a letter of invitation asking him/her to ring the AIBL Active study team if he/she was interested in finding out the details. Those who did not respond were telephoned by AIBL study staff and, with verbal permission, their telephone number was forwarded to the AIBL Active team. Once the study was described to a participant and he/she expressed interest in taking part, he/she first underwent a telephone screening interview to further determine eligibility. If he/she passed the phone screen, we obtained written permission to contact his/her General Practitioner (GP) to request their medical history. If the GP was happy for the participant to take part and, upon review by the project's medical team, he/she had no medical conditions that excluded him/her from participating, the participant was invited to undergo a baseline assessment. After the baseline assessment, the treatment was randomly allocated. A research assistant telephoned the statistician to obtain a randomisation number and the participant’s group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was undertaken in blocks. The blocks, containing random sequences of the codes 'blue' and 'red', were generated in STATA 10 (StataCorp, TX, USA), using the 'ralloc' command. The codes 'blue' and 'red' were employed so as to maintain masking of the data analysts to the participants' treatment allocation. The PA team decided which colour stands for each group and no one else was informed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
23/06/2011
Date of last participant enrolment
Anticipated
30/05/2015
Actual
24/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
156
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 267115 0
Government body
Name [1] 267115 0
National Health and Medical Research Council
Country [1] 267115 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Melbourne Research Office
Level 5, Alan Gilbert Building
The University of Melbourne, Vic
3010
Country
Australia
Secondary sponsor category [1] 264193 0
Other
Name [1] 264193 0
National Ageing Research Institute
Address [1] 264193 0
34-54 Poplar Road
Parkville, Vic
3052
Country [1] 264193 0
Australia
Other collaborator category [1] 252012 0
Other
Name [1] 252012 0
Mental Health Research Institute
Address [1] 252012 0
155 Oak Street
Parkville, Vic
3052
Country [1] 252012 0
Australia
Other collaborator category [2] 252013 0
University
Name [2] 252013 0
University of Western Australia
Address [2] 252013 0
School of Medicine and Pharamacology
GPO Box X2213
Perth, WA
6001
Country [2] 252013 0
Australia
Other collaborator category [3] 252017 0
Hospital
Name [3] 252017 0
Royal Melbourne Hospital
Address [3] 252017 0
Department of Radiology
Grattan Street
Parkville, Vic
3050
Country [3] 252017 0
Australia
Other collaborator category [4] 252018 0
Other Collaborative groups
Name [4] 252018 0
CSIRO
Address [4] 252018 0
343 Royal Parade
Parkville, Vic 3052

AND

Level 5
UQ Health Science Building 901/16
Royal Brisbane and Women's Hospital
Herston, Qld 4029
Country [4] 252018 0
Australia
Other collaborator category [5] 252019 0
University
Name [5] 252019 0
Edith Cowan University
Address [5] 252019 0
School of Exercise, Biomedical and Health Sciences
270 Joondalup Dr
Joondalup, WA
6027
Country [5] 252019 0
Australia
Other collaborator category [6] 252020 0
Hospital
Name [6] 252020 0
Austin Hospital
Address [6] 252020 0
Department of Nuclear Medicine and Centre for PET
Studley Road
Heidelberg, Vic
3084
Country [6] 252020 0
Australia
Other collaborator category [7] 278301 0
University
Name [7] 278301 0
University of Tasmania
Address [7] 278301 0
Room C001a, Building C, Newnham Campus
1 Newnham Close
Newnham, Tasmania
7250
Country [7] 278301 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267112 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 267112 0
Ethics committee country [1] 267112 0
Australia
Date submitted for ethics approval [1] 267112 0
Approval date [1] 267112 0
21/03/2011
Ethics approval number [1] 267112 0
2011.14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 285 285 0 0
/AnzctrAttachments/336961-Cyarto_aibl Active protocol paper_2012.pdf

Contacts
Principal investigator
Name 32639 0
Prof Nicola Lautenschlager
Address 32639 0
AUPOA - University of Melbourne Aged Persons Mental Health Program, Royal Melbourne Hospital, Royal Park Campus, Building 5, 34-54 Poplar Road, Parkville, Victoria 3052
Country 32639 0
Australia
Phone 32639 0
61 3 8387 2326
Fax 32639 0
Email 32639 0
nicolatl@unimelb.edu.au
Contact person for public queries
Name 15886 0
Elizabeth Cyarto
Address 15886 0
National Ageing Research Institute
PO Box 2127
Royal Melbourne Hospital
Parkville, Vic
3050
Country 15886 0
Australia
Phone 15886 0
+61 3 8387 2332
Fax 15886 0
+61 3 9387 4030
Email 15886 0
e.cyarto@nari.unimelb.edu.au
Contact person for scientific queries
Name 6814 0
Nicola Lautenschlager
Address 6814 0
AUPOA - University of Melbourne Aged Persons Mental Health Program, Royal Melbourne Hospital, Royal Park Campus, Building 5, 34-54 Poplar Road, Parkville, Victoria 3052
Country 6814 0
Australia
Phone 6814 0
61 3 8387 2326
Fax 6814 0
Email 6814 0
nicolatl@unimelb.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
SourceTitleYear of PublicationDOI
EmbaseSemi-automated hippocampal segmentation in people with cognitive impairment using an age appropriate template for registration.2015https://dx.doi.org/10.1002/jmri.24966
EmbaseA Randomized Controlled Trial of Adherence to a 24-Month Home-Based Physical Activity Program and the Health Benefits for Older Adults at Risk of Alzheimer's Disease: The AIBL Active-Study.2019https://dx.doi.org/10.3233/JAD-180521
EmbaseEffect of a 24-month physical activity program on brain changes in older adults at risk of Alzheimer's disease: the AIBL active trial.2020https://dx.doi.org/10.1016/j.neurobiolaging.2019.02.030
N.B. These documents automatically identified may not have been verified by the study sponsor.