SYN2: SYNchronizing, Exercises and Remedies to GaIn Cognition@Home
Study Details
Study Description
Brief Summary
In Canada, 1,700,000 adults are at risk of dementia, half of them with MCI, representing one of the largest groups at risk for an incurable disease. Epidemiological evidence suggests up to 40% of dementia cases might be preventable by targeting modifiable lifestyle/cardiovascular factors.Given that current treatments cannot modify the disease, prevention is critical. SYNERGIC-2 offers a "personalized tailored intervention" that combines physical and cognitive training, sleep, diet, and vascular-metabolic interventions in individuals with MCI to synergistically enhance their overall brain health including cognition and contributes to maintaining their independence. Importantly, interventions will be provided at home using an existing virtual platform reducing delivery complexity and expanding the accessibility to a wider population, thus decreasing potential inequities. Improving older adults' brain health and achieving even a modest two-year dementia incidence delay will have a projected saving of $218 Billion in Canada's healthcare system over 30 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Epidemiological evidence suggests up to 40% of potential dementia cases might be preventable by targeting modifiable lifestyle and cardiovascular factors; given that current treatments cannot modify the disease, prevention is a critical aspect. SYNERGIC-2 is the first large Canadian clinical trial using a 12-month home-based personalized multidomain lifestyle intervention to improve cognition in 550 older adults with Mild Cognitive Impairment (MCI), a pre-dementia state. These personalized at-home interventions target 5 domains with tailored physical exercise, cognitive training, diet recommendations, sleep interventions, and vascular risk factor management and are all delivered using a digital platform. Specifically, SYNERGIC-2 will be conducted with participants in their homes using video-conference meetings to test participants and to coach them 1-on-1 through the interventions on a web-based digital platform. The effect of these combined interventions on cognition will be compared to an online-educational program Brain Health PRO (BHPro). Both interventions are part of CAN-THUMBS UP, the interventional platform of the CCNA related to Canada Dementia Research Strategy; and constitutes Canada's contribution to the World-Wide-FINGERS Network. Importantly, these interventions have been selected because there is evidence that they synergistically enhance overall brain health including cognition and contributes to maintaining independence for individuals at risk for developing dementia.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: SYNERGIC 2 Personalized multidomain coached 1-to-1 interventions at home (PMI@Home) including: Physical Exercise Cognitive Training Diet Sleep Vascular Risk Factors Control |
Other: PMI@Home
Personalized multidomain interventional program by combining tailored lifestyle interventions that targets 5 domains: physical activity, cognition, diet, sleep, and vascular risk factors. These interventions are tailored based on participants' baseline profile and progress in intensity following the principles of personalized medicine. All aspects of the PMI@home will be delivered remotely, at participants' homes, using a "digital platform" with scheduled bi-weekly 1-to1 coaching sessions. Delivery of interventions and assessments are centralized with 5 trained staff at the sponsor site (London) to assure logistics, standardization, and quality control.
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| Placebo Comparator: Brain Health PRO (BHPro) Brain Health PRO (BHPROBHPRO) is an independent, educational program with content also related to: Physical Exercise Cognitive Training Diet Sleep Vascular Risk Factors |
Other: Brain Health Pro
Online Modules:
Motivation, Self-Efficacy, Positive Health, Environment and Genetic risk
Physical Activity
Cognitively Stimulating Activities
Diet
Sleep
Social and Psychological Health
Vascular health
Vision and Hearing
Lifestyle Risk Impact Surveys
Goal Setting
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Outcome Measures
Primary Outcome Measures
- Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13) [baseline and at 48 weeks (after interventions finalized)]
Global cognition will be assessed using the cognitive section of the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13). This scale consists of 13 brief cognitive tests assessing attention, memory, language, executive function, praxis, orientation, and instrumental activities of daily living. The ADAS-Cog has been a significant outcome measure in numerous trials with MCI and AD to measure changes in cognitive performance in populations with cognitive impairment, it score ranges from 0 to 84, with higher scores indicating worse cognitive performance.
Secondary Outcome Measures
- Change in Anthropometric Measures [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
Measurements of weight and hip/waist circumference will be done at home and self-reported by the participant. This can be used to characterize participant's body dimension and determine body mass index as kg/m^2 which can be used to estimate whether participants have obesity. A BMI greater than 30 is the cut off for obesity. Changes in waist circumference may also indicate visceral fat and cardiovascular risk.
- Change in Rated Perceived Exertion-Borg Scale [At coach interventions]
The Borg rating of perceived exertion examines self-reported perceptions of physical exertion on a scale ranging from 0 (no exertion at all) to 10 (maximal exertion), with higher scores indicating greater levels of physical exertion.
- Change in Canadian Diet History Questionnaire [Baseline and follow-up at 12 months]
The Canadian Diet History Questionnaire (CDHQ) is a 153-item questionnaire assessing dietary intake over the past year and is used to track patient's diet history/profile
- Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) is a short questionnaire assessing midlife vascular risk for dementia, with scores ranging from 0 to 15 (higher scores suggesting higher risk) and has cut-off score of 5 for high risk.
- Changes in the CCNA Gait Assessments results-Walking performance [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The CCNA gait assessment includes preferred and fast pace gait, and dual-task gait that comprises walking while performing three cognitively demanding tasks: counting backwards by ones, counting backwards by sevens, and naming animals. Participants will be asked to walk on a designated walking path(4 meters) in sight of camera
- Changes in Clinical Dementia Rating scores [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The Clinical Dementia Rating (CDR) scale is a validated scale (0-3) used in longitudinal Alzheimer's Disease (AD) research to characterize the impact of cognitive decline on global function performance applicable to AD and related dementias. Information is obtained through a semi-structured interview of the patient and a reliable informant or collateral source (e.g. family member). A score of ) indicate no cognitive impairment; 0.5 for Mild cognitive impairment; 1 for early dementia; 2 for mild severe dementia; 3 for severe dementia
- Changes in Cognitive Expectancy Questionnaire [Baseline and follow-up at 12 months]
The pre- and post- intervention versions of the CCNA-developed Cognitive Expectancies Questionnaire measures participant's expectancies about the cognitive benefits of the intervention. No score is provided.
- Changes in Digit Symbol Modalities Test - Oral Version (mental processing speed) [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The Digit Symbol Modalities Test is a 90-second, timed task that asks participants to orally match geometric figures with specific numbers according to a defined key (specifying which symbols are assigned to which numbers) that is provided at the top of the stimulus page. The oral Digit Symbol Modalities Test measures processing speed capabilities. The total number of numbers correctly matched with symbols is the final score for this test ranging from 0-110 correct numbers sequentially spoken.
- Changes in Eating Pattern Self-Assessment [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The Eating Pattern Self-Assessment (EPSA) is a 12-item questionnaire assessing participants' dietary intake profiles over the past 12 months. No score provided
- Changes in Fall Occurrence [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The monthly falls calendar that will be sent to help track any participant falls. Participants are being asked to complete this calendar on a daily basis in order to help investigators better track whether or not they have fallen since last intervention. A fall is defined as any unintentional event in which a participant falls to the ground or onto an object (e.g., a chair) no caused by a syncope or loss of consciousness. Total number of falls and consequences of falls is provided.
- Changes in Generalized Anxiety Disorder (GAD-7) [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
A questionnaire to score the frequency the participant experiences anxiety symptoms in the past 7 days with higher scores indicating worse anxiety symptoms. Score ranges from 0-21.
- Change in Geriatric Depression Scale (GDS-30) [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
A questionnaire to establish a participant's experience with depressive symptoms with higher score indicating more severe depressive symptoms. Score ranges from 0-30.
- Change in Health Utility Index (HUI-3) [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The HUI-3 provides descriptive health profile measures on a generic scale with higher scores indicating better quality of life and global functionality. HUI also provides single-attribute scores of morbidities for the following attributes; vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. Score ranges from one 1 to 6 or 1 to 5 depending on the domain; and sum of all domains could range from 8 to 45.
- Changes in Health Resource Utilization Questionnaire (HRUQ) [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The HRUQ provides an overall assessment of a participants utilization of health-related resource use and costs for elderly adults with and without mild cognitive impairment.There is no scoring for the HRUQ
- Changes in Insomnia Severity Index [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The Insomnia Severity Index (ISI) is a 7-item questionnaire assessing sleep onset, sleep maintenance, sleep satisfaction, and sleep problems.
- Changes in International Physical Activity Questionnaire scores [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
Modified for the elderly people, assesses older adults' level of physical activity, with a simple 7-item questionnaire. Scoring ranges from low, moderate and high.
- Changes in the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
Measures participant's ability to engage in instrumental activities of daily living via questionnaire assessing the ability to independently perform activities such as using the telephone, shopping, preparing meals, chores, household activities, managing prescriptions and medications, and managing personal finances. Score ranges from 0-23.
- Changes in the Mediterranean Diet Assessment [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
A 14-item questionnaire to help evaluate a participants Mediterranean ingredients in their diet. Score ranges from 0-14.
- Changes in global cognitive function using Montreal Cognitive Assessment(MoCA) [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The MoCA is a brief screening instrument designed to detect global cognitive dysfunction. It assesses a range of different cognitive domains, including attention, executive functions, memory, language, visuo-constructional skills, abstract thinking, and orientation. Score ranges from 0-30.
- Changes in the Oral Trail Making Test - Attention Shifting capabilities/executive functions using [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The Oral Trail Making Test (TMT) A & B is a two-part test that assesses attention speed, and mental flexibility and has been widely used in clinical settings for assessing deficits in attention and executive functioning. Score from part A ranges from 0-180; part B from 0-300 seconds. Longer times mean worse performance in the test.
- Changes in Quality of Life Questionnaire (SF-36) [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The Short-Form Quality of Life Questionnaire (SF-36) is a 36-item questionnaire assessing quality of life, with scores ranging from 0 to 100 and higher scores indicating better quality of life.
- Changes in Rey Auditory Verbal Learning Test (RAVLT)-Episodic memory [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
The Rey Auditory Verbal Learning Test (RAVLT) assesses episodic memory, in which the participant is presented with 15 words in five presentations or trials, after which they are asked to recall the words (immediately and after a delay). Score ranges from 0 to 15 words recalled.
- Changes in Stroop test scores - Inhibitory cognitive capabilities [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
Stroop Effect is a test of a participants visual perception and response. It is calculated [Stroop effect = score3 - (score1 * score2 / score1 + score2)]; the higher the Stroop effect value, the lower the interference effect, therefore the better the inhibitory/executive functioning capabilities
Other Outcome Measures
- Recruitment Rate [Throughout study completion - avg. 12 months/participant]
Defined as the total percent of enrolled participants relative to the number of people screened for eligibility. Score is calculated as the ratio of screened and enrolled participants per month. Higher scores = better recruitment rates.
- Retention Rate [Throughout study completion - avg. 12 months/participant]
Defined as the total percent of enrolled participants who continue throughout the trial and participate in outcomes assessments as follows: Enrollment retention: of those enrolled participants, the % who complete immediate 6-month post intervention assessment, and; Follow-up retention: of those who complete the immediate 6-month post intervention follow-up assessment, the % of participants who complete the 6-month post-intervention follow-up assessment at 12-months.
- Assessment Tolerability [Baseline]
Defined as total percent of participants not voluntarily dropping out during baseline or between baseline assessment and prior to allocation to intervention group.
- Adverse Events [Throughout study completion - avg. 12 months/participant]
Frequency cross-tabulation of AE severity versus AE relation to trial
- Data Loss [Throughout study completion - avg. 12 months/participant]
Defined as data lost due to technical failures, personnel errors or participant non-compliance and is calculated as percentages.
- Sex of Participant [Baseline]
This measurement will be self-reported.
- Age of Participant [Baseline]
This measurement will be self-reported.
- Medications Taken by Participant [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
This measurement will be self-reported. And will be reported as individuals medications and total amount.
- Chronic Diseases of Participant [Baseline, mid-intervention at 6 months, and follow-up at 12 months]
This measurement will be self-reported and will be monitored throughout the trial
- Hearing Ability of Participants [Screening]
This measurement will be gathered through the Revised Hearing Handicap Inventory (RHHI-S); it is a 10-item questionnaire assessing hearing ability, with higher scores indicating greater handicap (scores below 6 indicate sufficient hearing to participate).
- Participant Ability to Partake in Exercise(GAQ-Short) [Screening]
The Get Active Questionnaire is a short (6-item) standardized exercise stress test to screen for physical activity levels and is part of the Canadian Society for Exerciser Physiology (CSEP) developmental guidelines to determine safety to participate in exercise programs. Participants must respond as "no" to all items to be cleared to partake in the exercise program.
Eligibility Criteria
Criteria
Inclusion Criteria
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Aged 60-85 years.
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Having Mild Cognitive Impairment (MCI) defined as the following:
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Presence of subjective memory complaints from the participant or family.
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Objective impairment on cognitive tests independent of outcome measures. †
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Preserved activities of daily living assessed (>14/23 in Lawton-Brody scale)
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Absence of dementia established using DSM-IV criteria †Objective cognitive impairment is operationalized as: MoCA Test scores=16-26/30, , and/or Clinical Dementia Rating Scale≤0.5
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≥2 additional dementia risk factors targeted by our intervention as follows: low physical activity poor diet (MDA-14≤7),insomnia (ISI≥15), and vascular-metabolic risk (CAIDE ≥6).
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Internet access (have regular access to email), technology ability (able to send and receive emails), and access to a home computer and/or laptop computer device.
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Self-reported levels of proficiency in English for speaking and understanding spoken and written language.
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Have normal/corrected to normal vision in at least one eye to identify stimuli on computer screen.
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Have sufficient hearing ability, as determined via the Revised Hearing Handicap Inventory-Screening (RHHI-S), with scores below 6 indicating sufficient hearing ability to participate
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Able to comply with virtual visits, treatment plan, trial procedures and safety to participate in the study's exercise training as determined by the "Get Active Questionnaire".
Exclusion Criteria
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Having a diagnosis of dementia (based on DSM-IV criteria).
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Underlying severe disease that precludes engagement with interventions, including presence of 2 psychiatric diagnoses including major depression (>8/15 on the Geriatric Depression Scale-GDS-30),27 schizophrenia, severe anxiety, neurological disorder with severe motor deficits, such as current parkinsonism or any neurological disorder with residual motor deficits (i.e., stroke with motor deficit), active musculoskeletal disorders (i.e., severe active osteoarthritis of lower limbs), or presence of unstable chronic disease such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), or active cancer.
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Having had surgery within the last two months or having an upcoming planned surgery in the coming 12 months that could interfere with the participant's vision, hearing, mobility, or any other abilities to participate in the study.
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Regular Benzodiazepine or neuroleptic use that may interfere with the participants ability to participate in the assessments and interventions.
Recent -last 12 months- and current drug/alcohol abuse.
- Intention to enroll in other clinical trials during same time.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Joseph's Health Care London, Parkwood Hospital | London | Ontario | Canada | N6C5J1 |
Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
- Principal Investigator: Manuel Montero-Odasso, MD, PhD, St. Joseph's Health Care London, Parkwood Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
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