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Trial registered on ANZCTR


Registration number
ACTRN12616001148460
Ethics application status
Approved
Date submitted
17/08/2016
Date registered
23/08/2016
Date last updated
10/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of studying a new language and health-related lifestyle recommendations on thinking abilities and biomarkers in older individuals with memory complaints.
Scientific title
The impact of studying a new language and health-related lifestyle recommendations on cognitive performance and biomarkers in older individuals with subjective memory decline: a randomised controlled trial.
Secondary ID [1] 289050 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjective cognitive decline 297724 0
Preclinical asymptomatic Alzheimer's Disease 298299 0
Condition category
Condition code
Neurological 298425 298425 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Language: participants will complete a six-month course in French using a free online language course (www.duolingo.com). Participants will receive an e-mail inviting them to sign up and join an online classroom wherein they will be able to access the material. There are three levels: beginner, intermediate, and advanced. Participants will start from the beginner level and work their way to more complex levels at a pace of approximately four three to four hours of engagement per week.

2) The primary goals of the program are for participants to complete a minimum of 150 minutes of physical activity at moderate intensity each week and engage in a further 30 minutes of moderate to high intensity exercise per week. The secondary goals will include (i) a mix of aerobic exercise, resistance-based exercise, balance and flexibility exercises to be included in the overall program; (ii) Basic dietary advise which is in accordance with guidelines (Farrow M, Ellis K. Physical activity for brain health and fighting dementia. Alzheimer’s Australia Paper 36. 2013; Alzheimer’s Australia: Canberra). The program will incorporate face-to-face sessions with allied health services (6 sessions/26 weeks) which will include specifically designed (to the needs of the individual) functional testing, advise, demonstrations, and support.

There will be a total of 6 sessions during which advice and guidance on exercises and lifestyle choices will be delivered

Exercise program will be developed by an Accredited Exercise Physiologist (accreditation through Exercise and Sports Science Australia, ESSA) taking into consideration physical capacity, medical information, exercise history, exercise preferences, exercise barriers/enhancers. The physical activity program will be reviewed and adherence assessed at each subsequent meeting.

This will be delivered during face to face sessions each month (~once per 4 weeks) which are scheduled for 45 minutes.

The sessions will be conducted as 6x45 minute sessions. The first session includes assessment of physical function/capacity, medical information and exercise history. An exercise program along with physical activity advise (incidental exercise) is designed/provided during this session. The next session includes a review of activity and exercise habits, modification of program. Healthy eating patterns are discussed during this session. The next session reviews/modifies physical activity program; nutrition label reading is included. The next session reviews/modifies physical activity program; appetite changes, and incidental activity promotion is discussed. The next session reviews/modifies physical activity program; reassessment of functional capacity.

Participants will receive lifestyle advice using a program based on current guidelines (Farrow M, Ellis K. Physical activity for brain health and fighting dementia. Alzheimer’s Australia Paper 36. 2013; Alzheimer’s Australia: Canberra) and in accordance with treatment as usual for aged individuals (Tiedemann A, et al. Exercise and Sports Science Australia Position Statement on exercise and falls prevention in older people. J Sci Med Sport(2011), doi:10.1016/j.jsams.2011.04.001; National Institute for Aging. Exercise&Physical Activity: Your Everyday Guide from the National Institute on Aging! December 2016. https://go4life.nia.nih.gov/).
Intervention code [1] 293993 0
Lifestyle
Comparator / control treatment
The only difference between the intervention and control group is the language component. Both group with receive the physical activity program, but only the intervention group will receive the language course.
Control group
Active

Outcomes
Primary outcome [1] 297442 0
Episodic memory - California Verbal Learning Test-II (CVLT-II)
Timepoint [1] 297442 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [1] 326796 0
Estimation of premorbid intellectual function - Montreal Cognitive Assessment (MoCA)
Timepoint [1] 326796 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [2] 326797 0
Verbal Memory - Cambridge Contextual Reading Test (CCRT) (New Participants Only)
Timepoint [2] 326797 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [3] 326798 0
Visual attention and memory - CogState
Timepoint [3] 326798 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [4] 326799 0
Verbal attention and working memory - WAIS-III Digit Span
Timepoint [4] 326799 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [5] 326800 0
Executive function - Trailmaking Test A&B
Timepoint [5] 326800 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [6] 326801 0
Verbal fluency, executive function - Controlled Oral Word Association Test (COWAT) (CFL, Actions, Switching)
Timepoint [6] 326801 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [7] 326802 0
Visual construction and memory - Rey Complex Figure Test (RCFT)
Timepoint [7] 326802 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [8] 326803 0
Subjective measure of dimensional depression, anxiety and stress - DASS-21
Timepoint [8] 326803 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [9] 326804 0
Current concerns and complaints regarding memory in a variety of domains - Memory Complaints Questionnaire
(MAC-Q)
Timepoint [9] 326804 0
Baseline
Secondary outcome [10] 326805 0
Endorsement of any current difficulty with higher level activities of daily living (e.g., managing medications) - Activities of Daily Living Questionnaire (ADLQ) (Self and Informant Rating)
Timepoint [10] 326805 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [11] 326806 0
Estimates of decline observed in memory and other cognitive functions - Informant Questionnaire on Cognitive Decline (IQCODE)
Timepoint [11] 326806 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [12] 326807 0
Assessment of physical activity - Physical Activity Questionnaire (CHAMPS)
Timepoint [12] 326807 0
At baseline, three months into the intervention, six, and twelve months after randomisation
Secondary outcome [13] 326915 0
Glucose metabolism using fludeoxyglucose (18F) with positron emission tomography
Timepoint [13] 326915 0
At baseline
Secondary outcome [14] 326916 0
Apolipoprotein E allele from blood sampling
Timepoint [14] 326916 0
At baseline
Secondary outcome [15] 326918 0
body composition via Dual Energy X-ray Absorptiometry
Timepoint [15] 326918 0
At the six and twelve month time points.
Secondary outcome [16] 331581 0
Actigraphs (accelerometry)
Timepoint [16] 331581 0
Baseline (this will be worn for seven consecutive days)
Secondary outcome [17] 331582 0
Plasma amyloid beta (40 and 42)
Timepoint [17] 331582 0
At baseline, six, and twelve months after randomisation
Secondary outcome [18] 331583 0
Apolipoprotein (ApoE) levels (as protein), which will be assessed using serum samples
Timepoint [18] 331583 0
At baseline, six, and twelve months after randomisation
Secondary outcome [19] 331584 0
Chemokines, which will be assessed using serum samples
Timepoint [19] 331584 0
At baseline, six, and twelve months after randomisation
Secondary outcome [20] 331585 0
Interleukins, which will be assessed using serum samples
Timepoint [20] 331585 0
At baseline, six, and twelve months after randomisation
Secondary outcome [21] 331586 0
Oxidative stress markers, which will be assessed using serum samples
Timepoint [21] 331586 0
At baseline, six, and twelve months after randomisation
Secondary outcome [22] 331587 0
Apolipoprotein E (APOE) genotyping
Timepoint [22] 331587 0
At baseline
Secondary outcome [23] 331588 0
The language history questionnaire (LHQ)
Timepoint [23] 331588 0
At baseline
Secondary outcome [24] 331589 0
Language exam
Timepoint [24] 331589 0
At baseline, three months into the intervention, six, and twelve months after randomisation

Eligibility
Key inclusion criteria
Between the ages of 60 and 85 years
English monolingual
Subjective memory complainers (self-reported) who score above 25 on the MAC-Q (the standard cut-off for identifying subjective memory complainers)
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-memory complainer
Bilingual individuals
Pregnant women (due to radiation safety regulations)
Participants who score below 24 on the MoCA (indicating the presence of mild cognitive impairment)
Participants who score six or above on the Geriatric Depression Inventory.
Any conditions (acute or chronic) which may be worsened through exercise (assessed using Stage One of the ESSA screening tool)
Unable to perform physical activity unhindered (e.g. walking)
Alcohol abuse
Individuals who have undergone prior tests involving radiation exposure (e.g. multiple X-rays, Barium Swallows etc.) and where involvement in this study would result in exceeding the recommended level of radiation for patients.

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)
Sequentially numbered, opaque envelopes containing the participant’s group assignment will be prepared by research staff not affiliated with this trial. The envelope will be opened after completion of baseline assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of eligible individuals will be performed following generation of a unique study id. A random number generator will be used to create a permuted-block randomization list with variable block sizes. Sequentially numbered, opaque envelopes containing the participant’s group assignment will be prepared by research staff not affiliated with this trial. The envelope will be opened after completion of baseline assessments.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a medium effect size (Cohen's d .5; based on clinical relevance), with power at .95, and alpha at .05, using a repeated-measure within-between interaction between time point one (baseline) and time point two (three months into the intervention) across two groups a power analysis yields a total sample size of 54 participants. Including a 20% attrition rate the total N will be ~ 64 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/01/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294324 0
University
Name [1] 294324 0
Murdoch University
Country [1] 294324 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 291698 0
Charities/Societies/Foundations
Name [1] 291698 0
Australia Alzheimer's Research Foundation
Address [1] 291698 0
85 Monash Ave, Nedlands WA 6009
Country [1] 291698 0
Australia
Secondary sponsor category [2] 291699 0
University
Name [2] 291699 0
University of Turku
Address [2] 291699 0
University of Turku
FI-20014 TURUN YLIOPISTO
FINLAND
Country [2] 291699 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295749 0
Human Research Ethics Committee - Murdoch University
Ethics committee address [1] 295749 0
Murdoch University
Chancellery Building Room 1.006
South Street, Murdoch
Western Australia 6150
Ethics committee country [1] 295749 0
Australia
Date submitted for ethics approval [1] 295749 0
30/11/2015
Approval date [1] 295749 0
05/05/2016
Ethics approval number [1] 295749 0
2015/253

Summary
Brief summary
Dementia is now the second leading cause of death in Australia and no cure exists. There is evidence to suggest that bilingualism and changes in lifestyle (e.g. increasing levels of physical activity and improving eating habits) are associated with improved health outcomes. We aim to explore whether studying a new language and health-related advice can improve cognitive performance and related biomarkers in subjective memory complainers (risk factor for AD). Participants (aged 60-85) with subjective memory complaints will be randomly allocated to one of two group: 6-month experimental groups: language learning + one-to-one health-related advice sessions and control (health advice only). Outcome measures include cognitive performance (e.g. episodic memory) and blood markers (e.g. Apoe E 4).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63714 0
Mr Stefano Brini
Address 63714 0
90 South St, Murdoch WA 6150
Murdoch University
Country 63714 0
Australia
Phone 63714 0
+61406765364
Fax 63714 0
Email 63714 0
[email protected]
Contact person for public queries
Name 63715 0
Stefano Brini
Address 63715 0
90 South St, Murdoch WA 6150
Murdoch University
Country 63715 0
Australia
Phone 63715 0
+61406765364
Fax 63715 0
Email 63715 0
[email protected]
Contact person for scientific queries
Name 63716 0
Stefano Brini
Address 63716 0
90 South St, Murdoch WA 6150
Murdoch University
Country 63716 0
Australia
Phone 63716 0
+61406765364
Fax 63716 0
Email 63716 0
[email protected]

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