Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001562268
Ethics application status
Approved
Date submitted
12/09/2018
Date registered
19/09/2018
Date last updated
28/02/2020
Date data sharing statement initially provided
28/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
CogStep: Evaluation of a 12-week combined home-based exercise and psychoeducation program on dementia risk in older adults aged >60 years.
Scientific title
CogStep Phase 2.0: Evaluation of a 12-week combined home-based exercise and psycho-education program on dementia risk, mood, health knowledge, cognition, sleep, metabolic markers and brain connectivity in individuals with cognitive difficulties.
Secondary ID [1] 295837 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
Cogstep: Phase 2.0
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 309284 0
Poor quality of life 309285 0
Physical dysfunction 309286 0
Psychological distress 309287 0
Condition category
Condition code
Public Health 308157 308157 0 0
Health promotion/education
Mental Health 308158 308158 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 308159 308159 0 0
Dementias
Neurological 308160 308160 0 0
Alzheimer's disease
Mental Health 308161 308161 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘CogStep Phase 2.0’ Intervention will comprise a program of combined home based exercise and psycho-education for a period of 12 weeks. The treatment program comprises two distinct parts:
Exercise Prescription: Immediately following the baseline assessments, an Exercise Physiologist will prescribe six individually tailored strength, balance and/or flexibility exercises based on individual results on physical assessment. In addition, participants will be given aerobic exercise goals to achieve each week. The participant will be prescribed exercises and goals tailored to their individual needs encompassing 6 x strength exercises in combination with an aerobic component e.g. walking/jogging (dependent on their ability), with the aim to reach American College of Sport Medicine exercise Guidelines of 150 minutes of moderate exercise per week.
This will be outlined with the participant and exercise barriers will be discussed to ensure adherence to the exercises at home. Participants will be provided with an exercise workbook including the prescribed exercises (images demonstrating the exercise, instructions for performing the exercise, options for progression or regression of difficulty, and prescribed volume of exercise), and an exercise tracking sheet for each exercise to monitor compliance. In accordance with standard clinical care, the exercise prescription will be reviewed by an Exercise Physiologist at Week 6 to ensure exercise prescription/intensity is appropriate for the duration of the trial.

Psycho-education sessions: Participants will also be given a video CD to take home with a total of 12 sessions, from which participants will be asked to sequentially view one session per week. These will be viewed alongside the implementation of the exercises prescribed. These psycho-education sessions will include 20-30 minute video talks provided by a range of clinicians including Neuropsychologists, Nurses, Clinical Psychologists, Sleep Psychologists, Exercise Physiologists and Nutritionists. Content from the sessions will also be provided in the form of a workbook that will be provided to the participant. This content and the videos have been developed by the Healthy Brain Ageing Program.
The sessions include the following content: Session 1: exercise; Session 2: diet; Session 3: brain and cognition; Session 4: memory strategies for ageing individuals; Session 5: managing medications; Session 6: vascular risk factors; Session 7: feeling safe at home in the community; Session 8: anxiety; Session 9: depression and Session 10: sleep.

Following the viewing of each session, participants will be encouraged to complete the corresponding activities and/or questions in the provided workbook. Each workbook activity will take participants approximately 10 minutes each week. Participants will be able to clarify any questions during monitoring phone calls at weeks 2, 4 and 9, as well as at the week 6 clinical review.

A trained research assistant or other researcher will be asked to administer the monitoring phone calls each week. They will also be asked during this phone call regarding their adherence to the psychoeducation.

Intervention code [1] 312174 0
Treatment: Other
Intervention code [2] 312175 0
Lifestyle
Intervention code [3] 312426 0
Prevention
Comparator / control treatment
Waitlist control
Participants randomized to the control condition will be on a waitlist for treatment and after the 12-week control period, an exercise workbook and psychoeducation workbook with accompanying video CD’s matching that of the ‘CogStep Phase2.0’ Intervention group, will be offered to them. Following randomization, participants will be provided with a handout containing generic exercise information. Mobile phone text messages consisting of general physical activity guidelines and health information will be sent to the waitlist control group on weeks 2, 4, 6 and 9 (to mirror contact time points with the intervention group). The messages will differ between weeks and will be managed via an automated electronic platform. Should the participant not have access to a device to receive these mobile phone text messages, a letter containing the same details will be mailed to the participant.
After the waitlist period, participants will be offered the 12-week exercise program and psychoeducation program. They will also be offered a 6-week review following the start of their programmed if they would like to attend.
Control group
Active

Outcomes
Primary outcome [1] 307130 0
A change in dementia risk as measured by the Australian National University – Alzheimer’s Disease Risk Index (ANU-ADRI).
Timepoint [1] 307130 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [1] 350772 0
Change in clinician-rated apathy symptoms as determined by the Apathy Evaluation Scale.
Timepoint [1] 350772 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [2] 350773 0
Objective change in 6-Metre Timed Walk Test measurements via the GAITRite software and walkway
Timepoint [2] 350773 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [3] 350774 0
Objective change in balance as determined by the Timed Single Leg Stand, 3-metre Timed up and Go Test, and the Functional Reach Assessment.
Timepoint [3] 350774 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [4] 350776 0
Objective change in hand grip strength as measured by a hand grip dynamometer.
Timepoint [4] 350776 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [5] 350777 0
Change in functional connectivity via resting state functional MRI.
Timepoint [5] 350777 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [6] 350778 0
Change in self-reported psychological wellbeing (including apathy, depression and anxiety) as determined by the 15-item Geriatric Depression Scale (GDS-15).
Timepoint [6] 350778 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [7] 350779 0
Change in self-reported sleep quality as determined by the Pittsburgh Sleep Quality Index (PSQI) .
Timepoint [7] 350779 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [8] 350780 0
Change in blood LDL cholesterol.
Timepoint [8] 350780 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [9] 350781 0
Objective change in executive function via the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Timepoint [9] 350781 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [10] 350782 0
Objective verbal learning and memory performance as measured by the California Verbal Learning Test (CVLT).
Timepoint [10] 350782 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [11] 350783 0
Changes in verbal fluency as measured by the Controlled Oral Word Association Task (COWAT).
Timepoint [11] 350783 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [12] 350784 0
Compliance with the intervention arm (for those randomised to the intervention condition). Adherence with the intervention arm will be checked using a participant diary of compliance to the exercise program and using questions during monitoring calls.
Timepoint [12] 350784 0
At a 6-week clinical review and week 13 (directly following intervention/waitlist control).
Secondary outcome [13] 351916 0
Change in clinician-rated apathy and depressive symptoms as determined by the Hamilton Rating Scale for Depression.
Timepoint [13] 351916 0
Baseline and week 13 (directly following intervention/waitlist control)
Secondary outcome [14] 351917 0
Objective change in the 6-Minute Walk Test measurements via the GAITRite software and walkway
Timepoint [14] 351917 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [15] 351918 0
Objective change in balance as determined by the 3-metre Timed up and Go Test.
Timepoint [15] 351918 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [16] 351919 0
Objective change in balance as determined by the Functional Reach Assessment.
Timepoint [16] 351919 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [17] 351920 0
Change in neurometabolite markers of oxidative stress (glutathione) via proton magnetic resonance spectroscopy, respectively.
Timepoint [17] 351920 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [18] 351921 0
Change in neuronal integrity (n-acetyl aspartate) assessed via resting state functional MRI and proton magnetic resonance spectroscopy, respectively.
Timepoint [18] 351921 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [19] 351922 0
Change in self-reported psychological wellbeing (including apathy, depression and anxiety) as determined by the Apathy Evaluation Scale (Participant Version)
Timepoint [19] 351922 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [20] 351923 0
Change in self-reported psychological wellbeing (including apathy, depression and anxiety) as determined by the 7-item Generalised Anxiety Disorder scale (GAD-7),
Timepoint [20] 351923 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [21] 351925 0
Change in self-reported psychological wellbeing (including apathy, depression and anxiety) as determined by the 18-item Lubben Social Network Scale.
Timepoint [21] 351925 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [22] 351926 0
Change in self-reported psychological wellbeing (including apathy, depression and anxiety) as determined by the Social Adaptation Self-Evaluation Scale.
Timepoint [22] 351926 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [23] 351927 0
Change in self-reported sleep quality as determined by the Healthy Brain Ageing Sleep Questionnaire.
Timepoint [23] 351927 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [24] 351928 0
Change in fasting blood glucose.
Timepoint [24] 351928 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [25] 351929 0
Objective change in processing speed via the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Timepoint [25] 351929 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [26] 351930 0
Objective change in learning via the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Timepoint [26] 351930 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [27] 351931 0
Objective change in visual memory, via the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Timepoint [27] 351931 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [28] 351932 0
Objective change in verbal memory, via the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Timepoint [28] 351932 0
Baseline and week 13 (directly following intervention/waitlist control).
Secondary outcome [29] 351933 0
Objective change in episodic memory, via the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Timepoint [29] 351933 0
Baseline and week 13 (directly following intervention/waitlist control).

Eligibility
Key inclusion criteria
• Have a The Memory and Ageing Telephone Screen (MATS) score between 13 and 19;
• Be greater than 60 years old at time of assessment;
• Be willing to attend the baseline (week 1) and follow-up (week 13) assessments at the Brain and Mind centre;
• Be willing to undergo Magnetic Resonance Imaging scanning at the Brain and Mind centre;
• If randomised to the intervention arm, be willing to view the weekly psychoeducation sessions at home and implement their prescribed exercises at home; and
• If randomised to the control arm, be willing to receive health information via text message, email or letter at weeks 2, 4, 6, and 9.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have insufficient language skills for neuropsychological assessment;
• Have dementia or suspected dementia (MATS <13);
• Have history of any other major neurological conditions (e.g., stroke, epilepsy);
• Have current severe mood disturbance (K10 score >30);
• Have a history of head injury with a loss of consciousness for greater than 30 minutes;
• Have a medical condition known to affect cognition (e.g., cancer);
• Have a high level of baseline physical activity at study commencement (i.e., meets minimum American College of Sport Medicine exercise guidelines);
• Have any exercise contraindications (including unstable angina, uncontrolled cardiac failure, severe aortic stenosis, uncontrolled hypertension, symptomatic hypotension, resting tachycardia or arrhythmia, uncontrolled diabetes or acute illness/fever);
• Have any contraindications for magnetic resonance imaging scanning (e.g., aneurysm clip, pacemaker etc);
• Have started taking any new medications in the two months prior to commencement of the trial; and/or
• Are the current recipient of a cognitive training intervention (therapist or internet-based).

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)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
There will be two groups of participants. During the first 12-weeks of the study procedure, one group will receive an individually tailored exercise program and a video CD containing 12 psychoeducation sessions to complete. Concurrently, the control group will receive a handout containing generic exercise information and will be sent mobile text messages containing general physical activity guidelines and health information. After the intervention group has completed the 12-week intervention period, the waitlist control group will be offered the psychoeducation video CD’s and workbook, matching that of the intervention group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, no formal power analyses have been conducted for the purposes of determining sample size and effect sizes needed. This study is exploratory in nature and the outcomes will be used to power a larger, more rigorous randomised controlled trial.

Group differences at baseline will be assessed using independent samples t-tests for continuous data and chi-squared tests for categorical data (such as gender). A repeated measures analysis of variance will be used to examine group differences in primary and secondary outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2018
Actual
17/05/2019
Date of last participant enrolment
Anticipated
30/08/2019
Actual
6/09/2019
Date of last data collection
Anticipated
30/11/2019
Actual
29/11/2019
Sample size
Target
25
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300433 0
University
Name [1] 300433 0
Sydney Medical School, The University of Sydney
Country [1] 300433 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Research Grants and Contracts
Level 6, Jane Foss Russell Building (G02)
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 299895 0
None
Name [1] 299895 0
Address [1] 299895 0
Country [1] 299895 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301236 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 301236 0
Ethics committee country [1] 301236 0
Australia
Date submitted for ethics approval [1] 301236 0
03/05/2018
Approval date [1] 301236 0
21/01/2019
Ethics approval number [1] 301236 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3003 3003 0 0
/AnzctrAttachments/375818-Ethicsapprovalletter.pdf (Ethics approval)
Attachments [2] 3004 3004 0 0
/AnzctrAttachments/375818-CogStep2.0_Protocol_V3.docx (Protocol)
Attachments [3] 3005 3005 0 0
/AnzctrAttachments/375818-CogStep2.0_Participant_PIS_V2.doc (Participant information/consent)
Attachments [4] 3006 3006 0 0
/AnzctrAttachments/375818-CogStep2.0_Participant_ConsentForm_V1.docx (Participant information/consent)

Contacts
Principal investigator
Name 86330 0
Dr Shantel Duffy
Address 86330 0
Faculty of Health Sciences,
The University of Sydney
Level 2, Building D17
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
T
Country 86330 0
Australia
Phone 86330 0
+61 2 8627 1807
Fax 86330 0
Email 86330 0
shantel.duffy@sydney.edu.au
Contact person for public queries
Name 86331 0
Shantel Duffy
Address 86331 0
Faculty of Health Sciences,
The University of Sydney
Level 2, Building D17
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country 86331 0
Australia
Phone 86331 0
+61 2 8627 1807
Fax 86331 0
Email 86331 0
shantel.duffy@sydney.edu.au
Contact person for scientific queries
Name 86332 0
Shantel Duffy
Address 86332 0
Faculty of Health Sciences,
The University of Sydney
Level 2, Building D17
Charles Perkins Centre,
John Hopkins Drive,
Camperdown NSW 2050
Country 86332 0
Australia
Phone 86332 0
+61 2 8627 1807
Fax 86332 0
Email 86332 0
shantel.duffy@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial
When will data be available (start and end dates)?
Available when study is published, no end date determined.
Available to whom?
Researchers requesting data only.
Available for what types of analyses?
For IPD meta-analyses or to achieve the aims in the approval proposal.
How or where can data be obtained?
By emailing the Principal Investigator (shantel.duffy@sydney.edu.au)


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.