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SYNchronizing, Exercises and Remedies to GaIn Cognition@Home (SYN2)

Primary Purpose

Mild Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PMI@Home
Brain Health Pro
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Dementia, Mild Cognitive Impairment, Virtual Interventions, Geriatric Medicine

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  1. Aged 60-85 years.
  2. Having Mild Cognitive Impairment (MCI) defined as the following:

    1. Presence of subjective memory complaints from the participant or family.
    2. Objective impairment on cognitive tests independent of outcome measures. †
    3. Preserved activities of daily living assessed (>14/23 in Lawton-Brody scale)
    4. 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
  3. ≥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).
  4. 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.
  5. Self-reported levels of proficiency in English for speaking and understanding spoken and written language.
  6. Have normal/corrected to normal vision in at least one eye to identify stimuli on computer screen.
  7. 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
  8. 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

  1. Having a diagnosis of dementia (based on DSM-IV criteria).
  2. 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.
  3. 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.
  4. 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.

  5. Intention to enroll in other clinical trials during same time.

Sites / Locations

  • St. Joseph's Health Care London, Parkwood Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SYNERGIC 2

Brain Health PRO (BHPro)

Arm Description

Personalized multidomain coached 1-to-1 interventions at home (PMI@Home) including: Physical Exercise Cognitive Training Diet Sleep Vascular Risk Factors Control

Brain Health PRO (BHPROBHPRO) is an independent, educational program with content also related to: Physical Exercise Cognitive Training Diet Sleep Vascular Risk Factors

Outcomes

Primary Outcome Measures

Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13)
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
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
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
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
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
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
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
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)
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
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
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)
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)
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)
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)
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
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
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
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
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)
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
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)
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
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
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

Full Information

First Posted
April 21, 2022
Last Updated
May 10, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05375513
Brief Title
SYNchronizing, Exercises and Remedies to GaIn Cognition@Home
Acronym
SYN2
Official Title
SYNchronizing, Exercises and Remedies to GaIn Cognition@Home). A Home-based Personalized Multidomain RCT From the Canadian Therapeutic Platform for Multidomain Interventions to Prevent Dementia (CAN-THUMBS UP)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Dementia, Mild Cognitive Impairment, Virtual Interventions, Geriatric Medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The SYNERGIC-2 Trial is a single-blind, two-arm, randomized controlled trial (RCT) evaluating the cognitive effect of personalized multidomain interventions that target physical exercise, cognitive training, sleep, diet, and vascular risk factors. The SYNERGIC-2 Trial will be administered virtually through online video conferencing platform systems (WeBex or Zoom Healthcare©). Figure 1 illustrates the trial design. The trial adheres to the Consolidated Standards of Reporting Trials (CONSORT) guidelines for conducting and reporting clinical trials, as extended to non-pharmacological interventions. A total of 550 participants with MCI aged 60-85 will be enrolled and randomized into one of two arms, with 275 participants in each arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SYNERGIC 2
Arm Type
Active Comparator
Arm Description
Personalized multidomain coached 1-to-1 interventions at home (PMI@Home) including: Physical Exercise Cognitive Training Diet Sleep Vascular Risk Factors Control
Arm Title
Brain Health PRO (BHPro)
Arm Type
Placebo Comparator
Arm Description
Brain Health PRO (BHPROBHPRO) is an independent, educational program with content also related to: Physical Exercise Cognitive Training Diet Sleep Vascular Risk Factors
Intervention Type
Other
Intervention Name(s)
PMI@Home
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brain Health Pro
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in global cognition assessed using the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with 13 items (ADASCog-13)
Description
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.
Time Frame
baseline and at 48 weeks (after interventions finalized)
Secondary Outcome Measure Information:
Title
Change in Anthropometric Measures
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Change in Rated Perceived Exertion-Borg Scale
Description
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.
Time Frame
At coach interventions
Title
Change in Canadian Diet History Questionnaire
Description
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
Time Frame
Baseline and follow-up at 12 months
Title
Change in Cardiovascular Risk Factors, Aging, and Incidence of Dementia
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in the CCNA Gait Assessments results-Walking performance
Description
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
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Clinical Dementia Rating scores
Description
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
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Cognitive Expectancy Questionnaire
Description
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.
Time Frame
Baseline and follow-up at 12 months
Title
Changes in Digit Symbol Modalities Test - Oral Version (mental processing speed)
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Eating Pattern Self-Assessment
Description
The Eating Pattern Self-Assessment (EPSA) is a 12-item questionnaire assessing participants' dietary intake profiles over the past 12 months. No score provided
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Fall Occurrence
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Generalized Anxiety Disorder (GAD-7)
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Change in Geriatric Depression Scale (GDS-30)
Description
A questionnaire to establish a participant's experience with depressive symptoms with higher score indicating more severe depressive symptoms. Score ranges from 0-30.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Change in Health Utility Index (HUI-3)
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Health Resource Utilization Questionnaire (HRUQ)
Description
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
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Insomnia Severity Index
Description
The Insomnia Severity Index (ISI) is a 7-item questionnaire assessing sleep onset, sleep maintenance, sleep satisfaction, and sleep problems.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in International Physical Activity Questionnaire scores
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in the Mediterranean Diet Assessment
Description
A 14-item questionnaire to help evaluate a participants Mediterranean ingredients in their diet. Score ranges from 0-14.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in global cognitive function using Montreal Cognitive Assessment(MoCA)
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in the Oral Trail Making Test - Attention Shifting capabilities/executive functions using
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Quality of Life Questionnaire (SF-36)
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Rey Auditory Verbal Learning Test (RAVLT)-Episodic memory
Description
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.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Changes in Stroop test scores - Inhibitory cognitive capabilities
Description
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
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Other Pre-specified Outcome Measures:
Title
Recruitment Rate
Description
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.
Time Frame
Throughout study completion - avg. 12 months/participant
Title
Retention Rate
Description
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.
Time Frame
Throughout study completion - avg. 12 months/participant
Title
Assessment Tolerability
Description
Defined as total percent of participants not voluntarily dropping out during baseline or between baseline assessment and prior to allocation to intervention group.
Time Frame
Baseline
Title
Adverse Events
Description
Frequency cross-tabulation of AE severity versus AE relation to trial
Time Frame
Throughout study completion - avg. 12 months/participant
Title
Data Loss
Description
Defined as data lost due to technical failures, personnel errors or participant non-compliance and is calculated as percentages.
Time Frame
Throughout study completion - avg. 12 months/participant
Title
Sex of Participant
Description
This measurement will be self-reported.
Time Frame
Baseline
Title
Age of Participant
Description
This measurement will be self-reported.
Time Frame
Baseline
Title
Medications Taken by Participant
Description
This measurement will be self-reported. And will be reported as individuals medications and total amount.
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Chronic Diseases of Participant
Description
This measurement will be self-reported and will be monitored throughout the trial
Time Frame
Baseline, mid-intervention at 6 months, and follow-up at 12 months
Title
Hearing Ability of Participants
Description
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).
Time Frame
Screening
Title
Participant Ability to Partake in Exercise(GAQ-Short)
Description
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.
Time Frame
Screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Aged 60-85 years. Having Mild Cognitive Impairment (MCI) defined as the following: Presence of subjective memory complaints from the participant or family. Objective impairment on cognitive tests independent of outcome measures. † Preserved activities of daily living assessed (>14/23 in Lawton-Brody scale) 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 ≥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). 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. Self-reported levels of proficiency in English for speaking and understanding spoken and written language. Have normal/corrected to normal vision in at least one eye to identify stimuli on computer screen. 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 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 Having a diagnosis of dementia (based on DSM-IV criteria). 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. 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanina Sarquis Adamson
Phone
519-646-6100
Email
Yanina.SarquisAdamson@sjhc.london.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Frederico Faria, PhD
Phone
519-646-6100
Email
Frederico.Faria@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Montero-Odasso, MD, PhD
Organizational Affiliation
St. Joseph's Health Care London, Parkwood Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care London, Parkwood Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6C5J1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15012851
Citation
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