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Mild Cognitive ImpairmentSYNERGIC@HomNCT04997681

SYNchronizing Exercises, Remedies in Gait and Cognition at Home (SYNERGIC@Home)

A study testing Combined Aerobic Exercise and Resistance Training (AE + RT) and Cognitive Training (NeuropeakTM) in people with Mild Cognitive Impairment, run by University of New Brunswick at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Prevention of Alzheimer's Disease and Related Dementias (ADRDs) may be possible for persons with subjective (SCI) or mild cognitive impairment (MCI), or normal cognition and risk factors. Read more about this study

Who is it for?
Ages 60 to 90 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Combined Aerobic Exercise and Resistance Training (AE + RT) and Cognitive Training (NeuropeakTM)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteCanada
Study dates
28 Jul 2021to 27 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 60 to 90 years old.
  • Has a Family Physician
  • Has internet access (and have regular access to email), and the technology ability (able to send and receive emails).
  • Resides in their own home/apartment in the community.
  • Has access to a home computer and/or a tablet computer device.
  • Self-reported levels of proficiency in English and/or French for speaking and understanding spoken and written language.
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  • Able to comply with scheduled home-based assessments, interventions, and other trial procedures.
  • Able to ambulate at least 10 m independently with or without a walking aid.
  • Being at risk of developing dementia:
  • Mild Cognitive Impairment (MCI) Group. Diagnosis of Mild Cognitive Impairment, in accordance with the criteria used in the Comprehensive Assessment of Neurodegeneration and Dementia (COMPASS-ND) study2 (Table 1).
  • Subjective Cognitive Impairment (SCI) Group. Diagnosis of Subjective Cognitive Impairment, in accordance with the COMPASS-ND study2 definition (Table 1).
  • Cognitively Intact with Risk Factors Group. Cognitively Intact based on COMPASS ND study2 definition (Table 1)) AND have a history of two or more risk factors for dementia, defined as the following (Table 1):
  • Obesity: Defined as a Body Mass Index (BMI) > 30 kg/m2 (as derived from the National Institute of Health BMI calculator52)
  • Hypertension: Defined as a documented Systolic Blood Pressure > 140 mm Hg, OR a physician's diagnosis of hypertension, OR presence of physician prescribed medical treatment for hypertension, OR other approaches to treatment for hypertension (i.e., diet or exercise).
  • Diabetes: Defined as a physician's diagnosis of diabetes, OR presence of physician prescribed medical treatment for diabetes, OR other approaches to treatment for diabetes (i.e., diet or exercise).
  • Cardiovascular disease: Defined as a physician's diagnosis of angina, myocardial infarction, coronary revascularization or other arterial revascularization, stroke, transient ischemic attack and/or peripheral vascular disease.
  • Physical inactivity: Defined as inactive, whereby active is defined as engaging in a minimum of 20-30 minutes of physical activity causing sweating and breathlessness, at least two times per week.
  • First-degree family history of dementia: Defined as a physician's diagnosis of dementia in a first-degree relative, including a parent, sibling, or child.
  • Dyslipidemia: Defined as a documented total cholesterol > 6.5 mmol/L, OR a physician's diagnosis of hypercholesterolemia, OR presence of physician prescribed medical treatment for hypercholesterolemia, OR other approaches to treatment (e.g. diet, exercise).
  • Poor sleep: Defined as a score of 6 or higher on the PSQI-18 (higher scores indicate poorer sleep).
  • Poor diet: Defined as a score of 7 or less on the MDA-14.
  • Must be medically able to participate in the study's exercise training program, as determined using the Get Active Questionnaire (a screening tool developed by the Canadian Society for Exercise Physiology53), coupled with evaluation by a certified exercise physiologist and/or the study physician for clearance to participate in combined exercise training program.
  • Preserved activities of daily living operationalized as a score of > 14/23 on the Lawton-Brody Instrumental Activities of Daily Living (IADL) scale3 and confirmed by clinician's interviews.

Who cannot join

  • A diagnosis of dementia
  • Participants living in Nursing Homes or Adult Residential Facilities (Special Care Homes) will be excluded.
  • Serious underlying disease, which, in the opinion of the study physician excludes engagement in interventions or may interfere with the participant's ability to participate fully in the study.
  • Has had surgery within the last two months or has planned surgery in the coming 12 months that, deemed by the study physician, could interfere with the participant's vision, hearing, mobility or any other ability to participate in the study.
  • Has a history of intracranial surgery.
  • Regular Benzodiazepine use by a participant that the study physician determines to be significant enough to interfere with the participants ability to participate in the assessments and interventions in the study will be excluded.
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  • Presence of major depression, schizophrenia, severe anxiety or drug/alcohol abuse, or other medical illness that would prohibit them from safely participating in the study or may cause harm to the participant.
  • Current Parkinsonism or any neurological disorder with residual motor deficits (e.g. stroke with motor deficit), active musculoskeletal disorders (e.g. severe osteoarthritis of lower limbs), or history of knee/hip replacement affecting gait performance during the baseline assessment.
  • Severe visual and/or auditory impairment, which, according to the vision and hearing assessment, precludes the participant from engaging in the trial.
  • Intention to enroll in other clinical trials during the same time period.
  • Active participation in an organized and planned exercise program involving aerobic exercise and/or resistance training regimen in the previous 6 months.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The University of New Brunswick

    Fredericton, New Brunswick, E3B 5A2

Other trials in Canada

About this study

Official title: SYNchronizing Exercises, Remedies in Gait and Cognition at Home: Feasibility of a Home-based Double-blind Randomized Controlled Trial to Improve Gait and Cognition in Individuals at Risk for Dementia

Background: Prevention of Alzheimer's Disease and Related Dementias (ADRDs) may be possible for persons with subjective (SCI) or mild cognitive impairment (MCI), or normal cognition and risk factors. Physical exercise and cognitive training have been shown to enhance cognitive function and mobility in MCI when delivered in a research facility. The feasibility of delivering interventions in the home of older adults at risk for developing ADRDs is not known. What preferences the participants have for these interventions are also unknown. The primary goals are: 1) assess feasibility of a home-based delivery of exercise and cognitive interventions 2) evaluate the relationship between participants' intervention preferences and adherence. Secondary objectives focus on cognition, frailty, mobility, sleep, diet and mental health.

Methods and analysis: SYNERGIC@Home is a randomized control trial (using a 2 x 2 factorial design) with a 16-week home-based intervention program of physical exercises with cognitive training. Sixty-four participants will be randomized in blocks of four: 1) combined exercise (aerobic and resistance) + cognitive training (NEUROPEAK™); 2) combined exercise + control cognitive training (web searching); 3) control exercise (balance and toning) + cognitive training; and 4) control exercise + control cognitive training. It will be implemented virtually through video conferencing. Baseline, 4- and 10-month post-intervention will include measures of cognition, frailty, mobility, sleep, diet, and psychological health. Feasibility outcomes include recruitment and retention. Preference will be used to determine the relationship between preference adherence. Secondary outcomes will evaluate the effect of the interventions on cognitive, mobility, and general well-being.

Read the detailed description

BACKGROUND: Nearly half a million Canadians live with Alzheimer's Disease and Related Dementias (ADRDs), and approximately one third of those cases could have been prevented with early intervention. Physical exercise and cognitive training are emerging interventions that have the potential to enhance cognitive function and mobility in older adults at risk for developing dementia. The SYNERGIC trial (SYNchronizing Exercises, Remedies in GaIt and Cognition), a large multi-site randomized control trial, showed promising preliminary data that individuals in an active exercise intervention combining aerobic exercise with progressive resistance training (AE+RT) and in a cognitive training program (NEUROPEAKTM) had better cognitive outcomes than a balance and toning control (BAT) intervention paired with a control cognitive intervention consisting of website searching and watching a simple video (WS+V). While these interventions were provided face to face in a research facility, little is known about the feasibility of delivering these multi-domain interventions at home in older adults at risk for developing ADRDs. Thus, the primary goal of the present trial-the SYNERGIC@Home trial-is to establish the feasibility of delivering a combined multimodal exercise and cognitive training intervention program for 16 weeks to 64 older adults at home using video-conferencing.

HYPOTHESIS: Based on the success of the SYNERGIC trial, we expect that SYNERGIC@Home will follow suit and yield high recruitment, retention, and adherence rates-particularly in light of the fact that SYNERGIC@Home eliminates any of the natural inconveniences of in person testing.

METHODS: SYNERGIC@Home is a randomized control trial (RCT) with a 16-week home-based intervention program of combined physical exercises with cognitive training. Sixty-four participants will be randomized to one of the following four arms: 1) combined exercise (AE+RT) + cognitive training (NEUROPEAKTM); 2) combined exercise (AE+RT) + control cognitive training (WS+V); 3) Control exercise (BAT) + cognitive training (NEUROPEAKTM) ; and 4) Control exercise (BAT) + control cognitive training (WS+V). SYNERGIC@Home will be implemented entirely virtually through video and phone conferencing. Baseline, immediate post-intervention follow-up, and 6-month post-intervention follow-up assessments will include measures of cognition, frailty, mobility, sleep, diet, and psychological health. For primary feasibility objectives, we will obtain measures of recruitment and retention rates. For primary analytic objectives, we will examine the distribution of preference ratings and determine if there is a relationship between preference for a given intervention and subsequent adherence. A series of secondary analytic outcomes examining the potential effect of the individual and combined interventions on cognitive, mobility, and general well-being will be measured at both baseline and follow-up. If we find a relatively equal split in sex our sample, we will conduct gender-based analyses as additional, exploratory research.

EXPECTED RESULTS AND DISCUSSION: The SYNERGIC@Home trial will establish the feasibility of a combined multimodal intervention program delivered at home in older adults. Similarly, it will estimate the frequency and strength of participant preference for different interventions and delineate the relationship between intervention preference and subsequent adherence. It will also build capacity for and pilot the delivery of multi-domain interventions using an entirely home-based protocol with individuals at risk for ADRDs. The SYNERGIC@Home trial will inform future larger scale studies on the feasibility and success of implementing home-based interventions for individuals at risk for ADRDs. Insights gained from this feasibility trial will be instrumental in developing various other at home, remote, and virtual intervention programs for community-dwelling older adults.

Being tested
Combined Aerobic Exercise and Resistance Training (AE + RT), Cognitive Training (NeuropeakTM), Control Cognitive Training of Website Searching and Video Watching (WS+V), Control Balance and Toning Exercise Training (BAT)
Keywords
Exercise, Cognitive training, Intervention preference, Elderly, Gait, Dementia, Home-based intervention, Cognitive impairment
Medical subject headings
Cognitive Dysfunction, Motor Activity, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined Aerobic Exercise and Resistance Training (AE + RT)Behavioural

    AE + RT will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. AE + RT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 strength training exercises (that progressively increase in resistance intensity over time) will be completed followed by a break. Aerobic exercises that safely increase the participant's heart rate will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the AE + RT exercise session is approximately 65 minutes.

  • Cognitive Training (NeuropeakTM)Behavioural

    NeuropeakTM is a program which will be completed by participants remotely using a tablet or computer. It consists of cognitive training including dual-task training that requires participants to maintain and prepare for many response alternatives (working memory) and to share attention between two concurrent tasks (divided attention). Difficulty of cognitive training is tailored to their individual functioning level. During each session, participants perform one of two different visuo-motor tasks, which include sets of visual stimuli (e.g., letters, numbers, animals, vehicles, fruits, celestial bodies) and respective hand-button correspondences (i.e., keys that are to be tapped on either the right or the left side of the screen). Participants are instructed to perform these tasks as fast as possible, while maintaining accuracy. Training also includes online feedback and a histogram of daily performance to encourage improvement. NeuropeakTM takes approximately 30 minutes to complete.

  • Control Cognitive Training of Website Searching and Video Watching (WS+V)Behavioural

    During the WS + V task, participants alternate between 2 different tasks (touristic searching using internet and video watching). For the touristic searching using internet, participants are required to find 3 hotels, 3 touristic places, and 3 restaurants of their own preference in a city assigned by the instructor (a new city will be selected each session). They will also need to include the respective addresses of those places on their log sheet. For the video watching task, participants watch a National Geographic video on YouTube selected by the instructor with a different video selected for each session. They will watch the video for 20 minutes and during the remaining 5 minutes they will answer the following questions on their log sheet: 1) What is the video about? 2) What is the most important information in your opinion? 3) Create a question based on the video and answer your own question. WS + V sessions take approximately 30 minutes to complete.

  • Control Balance and Toning Exercise Training (BAT)Behavioural

    BAT exercises will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. BAT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 balance and toning exercises will be completed followed by a break. Stretching exercises will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the BAT exercise session is approximately 65 minutes.

Study groups in NCT04997681
Study groupRoleWhat they receive
Exercise Intervention Training and Cognitive Intervention TrainingExperimentalCombined Aerobic Exercise and Resistance Training (AE + RT) + Cognitive Training (NeuropeakTM)
Receives: Behavioral: Combined Aerobic Exercise and Resistance Training (AE + RT); Behavioral: Cognitive Training (NeuropeakTM)
Exercise Intervention Training and Control Cognitive TrainingActive comparatorCombined Aerobic Exercise and Resistance Training (AE + RT) + Control Cognitive Training of Website Searching and Video Watching (WS+V)
Receives: Behavioral: Combined Aerobic Exercise and Resistance Training (AE + RT); Behavioral: Control Cognitive Training of Website Searching and Video Watching (WS+V)
Control Exercise Training and Cognitive Intervention TrainingActive comparatorControl Balance and Toning Exercise Training (BAT) + Cognitive Training (NeuropeakTM)
Receives: Behavioral: Cognitive Training (NeuropeakTM); Behavioral: Control Balance and Toning Exercise Training (BAT)
Control Exercise Training and Control Cognitive TrainingPlacebo comparatorControl Balance and Toning Exercise Training (BAT) + Control Cognitive Training of Website Searching and Video Watching (WS+V)
Receives: Behavioral: Control Cognitive Training of Website Searching and Video Watching (WS+V); Behavioral: Control Balance and Toning Exercise Training (BAT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention Adherence

    Defined as the mean percent of all Intervention sessions attended of the 48 planned sessions per participant.

    Measured: Post-intervention at 4 months

  2. Intervention Preference

    The primary analytic goal of SYNERGIC@Home is to assess the relationship between participants' adherence to the interventions and their affinity for each intervention going into the trial. All participants will be given the Intervention Preference Questionnaire (IPQ) prior to implementation of the intervention

    Measured: Baseline

Secondary outcomes (64)

  1. Recruitment Rate

    Defined as the total percent of enrolled participants relative to number of people screened for eligibility.

    Measured: Through study completion, an average of 10 months

  2. Retention Rate

    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 4-month post intervention assessment, and;
    • Follow-up retention: of those who complete the immediate 4-month post intervention follow-up assessment, the % of participants who complete the 6-month post-intervention follow-up assessment at 10-months.

    Measured: Through study completion, an average of 10 months

  3. Assessment Tolerability

    Defined as total percent of participants not voluntarily dropping out during baseline or between baseline assessment and prior to allocation to intervention group.

    Measured: Baseline

  4. Trial Experience

    Trial experience is defined as participants' qualitative responses to semi-structured open-ended questions aimed at providing insights on their overall trial experience within the context of the Kirkland evaluation framework.

    Measured: 10 months follow-up

  5. Adverse Events

    Frequency cross-tabulation of AE severity versus AE relation to trial.

    Measured: Monitored from start of study until end of study

  6. Height

    This measurement will be done at home and self-reported.

    Measured: Baseline

  7. Data Loss

    Defined as data lost due to technical failures, personnel errors or participant non-compliance

    Measured: Through study completion, an average of 10 months

  8. Weight

    This measurement will done at home and self-reported.

    Measured: Baseline

  9. Sex

    This measurement will be self-reported.

    Measured: Baseline

  10. Age

    This measurement will be self-reported.

    Measured: Baseline

  11. Change in Hip Circumference

    This measurement will be done at home and self-reported.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  12. Change in Neck Circumference

    This measurement will be done at home and self-reported.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  13. Change in waist circumference

    This measurement will be done at home and self-reported.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  14. Change in blood pressure

    Measured with a provided blood pressure cuff. Reported systolic/diastolic.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  15. Change in heart rate

    Measured with a provided blood pressure cuff. Reported in beats/minute.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  16. Change in Medications

    This measurement will be self-reported.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  17. Chronic Diseases

    This measurement will be self-reported and will be monitored throughout the trial

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  18. Change in fall history

    Falls will be recorded throughout the trial, in which participants will be provided with a falls calendars, on which they will record any falls that have occurred, and the research team will collect them monthly.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  19. Change in Health Status and Self-Perception

    Participants will answer questions on their self-perception of their health status

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  20. Change in Constant Fatigue

    Participants will answer questions on fatigue.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  21. Change in Falls and Balance

    Participants will answer questions on falls and balance

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  22. Change in Vision

    Participants will answer questions on their vision

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  23. Change in Hearing

    Participants will answer questions on their hearing

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  24. Change in Nutrition

    Participants will answer questions on their nutrition.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  25. Change in Sleep

    Participants will answer questions on their sleep.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  26. Change in Mayo Fluctuation Scale

    Participants will answer questions on how they feel during a day. Scores range between 0 and 4 with higher scores meaning a worse outcome.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  27. Change in Telephone Cognitive Screen (TCogS)

    is a widely used tool that measures cognitive function in older individuals. The telephone version of the CogS has been standardized and will be administered via video conferencing. It consists of a 26-point assessment that measures orientation, registration, attention and calculation, recall, and language

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  28. Change in Clinical Dementia Rating Scale (CDR)

    The CDR is a validated 5-point composite scale used in longitudinal Alzheimer's Disease (AD) research to characterize cognitive and global function performance applicable to AD and related dementias.61 Information is obtained through a semi-structured interview of the patient and a reliable informant or collateral source (e.g. family member).

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  29. Change in remote version of the Montreal Cognitive Assessment (MoCA)

    The Full MoCA via Audio-Visual Conference consists of a 30-point test assessing the following items: short term memory recall, visuospatial abilities, executive functioning, phonemic fluency, verbal abstraction, attention, concentration, working memory, language, and orientation.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  30. Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) scale

    measures participant's ability to engage in instrumental activities of daily living via questionnaire assessing activities such as preparing meals and managing personal finances

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  31. Change in ADAS-Cog Immediate Word Recall

    Participants are presented with 10 high imagery words and are given three trials to learn and recall them.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  32. Change in ADAS-Cog Delayed Word Recall

    Participants are asked to recall the 10 high imagery words presented during the immediate word recall task after a delay of approximately 5 to 10 minutes.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  33. Change in ADAS-Cog Orientation

    Participants are asked 8 questions pertaining to their identity, the place, and the time.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  34. Change in Cognitive Functional Composite 2 (CFC-2)

    The CFC-2 is a collective of different test which consists of the ADAS-Cog Immediate Word Recall, ADAS-Cog Delayed Word Recall, ADAS-Cog Orientation, Clinical Dementia Rating Sum of Boxes (CDR-SB) Cognitive portion, and the Functional Activities Questionnaire.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  35. Functional Activities Questionnaire

    It measures participant's ability to engage in instrumental activities of daily living via questionnaire assessing activities such as preparing meals and managing personal finances

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  36. Change in Oral Trail Making Test (TMT) A

    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.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  37. Change in Oral Trail Making Test (TMT) B

    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.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  38. Change in 15-item Boston Naming Test (BNT)

    The Boston Naming Test (BNT) assesses visual confrontational naming and asks participants to name simple line drawings of objects.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  39. Change in Logical Memory I

    Logical Memory I \& II (Story A) from the Wechsler memory scale assesses memory and free recall. Scores range between 0 and 25 with higher scores meaning a better outcome.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  40. Change in Logical Memory II

    Logical Memory I \& II (Story A) from the Wechsler memory scale assesses memory and free recall. Scores range between 0 and 25 with higher scores meaning a better outcome.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  41. Change in ADAS-Cog Word Recognition

    Participants are presented with a list of 12 words and are then asked to identify the words among a list of distractor words.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  42. Change in The Delis-Kaplan Executive Function System (DKEFS) phonemic fluency test

    The Delis-Kaplan Executive Function System (DKEFS) phonemic fluency test measures phonemic verbal fluency.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  43. Change in The Delis-Kaplan Executive Function System (DKEFS) semantic fluency test

    The Delis-Kaplan Executive Function System (DKEFS) semantic fluency test measures speed and flexibility of verbal thought.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  44. Change in Digit Span Backward Test

    The digit span test is an auditory attention task, in which participants are asked to recall a series of numbers forward and backward.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  45. Change in Oral version of the Digit Symbol Modalities Test

    This is a timed task that gives participants 120 seconds 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.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  46. Change in 18-item Pittsburgh Sleep Quality Index (PSQI-18)

    This is a 18-item questionnaire to help evaluate a participants sleep quality

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  47. Change in Work and Sleep Diary (WSD)

    A self reported work and sleep diary to track activity and sleep during the assessments.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  48. Change in 14-item Mediterranean Diet Assessment (MDA-14)

    A 14-item questionnaire to help evaluate a participants diet.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  49. Change in Eating Pattern Self-Assessment

    The Eating Pattern Self-Assessment is a tool used for participants to provide a self-report on their eating patterns.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  50. Change in Questionnaire for Vitamin D intake

    A questionnaire to determine a participant's intake of Vitamin D.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  51. Change in Physical Activity Scale for the Elderly (PASE)

    A questionnaire to assess a participants activity level. Scores range from 0 to 400+ with higher scores meaning a better outcome.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  52. Change in Life Space Questionnaire (LSQ)

    A questionnaire to assess a participant's mobility ability.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  53. Change in Clinical Frailty Scale (CFS)

    This assessment will be performed by the Clinical Research Coordinator/nurse using the 9 point CFS instrument. This will allow for a determination of the clinical frailty of the participants. Scores range between 1 and 9 with higher scores meaning a worse outcome.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  54. Change in Short Form quality of life questionnaire (SF-36)

    A 36-item questionnaire that evaluates different aspects of quality of life.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  55. COVID-19 Questionnaire

    A questionnaire that assesses a participants experience with the current COVID-19 pandemic. Scores range from 10-40 when self reported or 8-33 when reported by a study partner.

    Measured: Baseline

  56. Change in Generalized Anxiety Disorder 7 (GAD 7)

    A questionnaire to establish a participant's experience with anxiety

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  57. Change in Geriatric Depression Scale (GDS-30)

    A questionnaire to establish a participant's experience with depression

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  58. Short Test of Functional Health Literacy in Adults (STOFHLA)

    Health Literacy will be assessed using the abbreviated version of the Test of Functional Health Literacy in Adults (TOFHLA).The short version, STOFHLA, consists of 2 prose passages and 4 numeracy items.

    Measured: Baseline

  59. Change in Functional Assessment of Currently Employed Technology Scale (FACETS)

    The FACETS is a 10-item questionnaire with possible responses falling on a Likert-type scale, and higher scores indicating more frequent use of technology domains.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  60. Change in seated dual task

    Participants will be asked to name as many animals as they are able to, count backwards by 1's, and count backwards by 7's while seated.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  61. Change in single-task gait

    Their gait velocity will be measured 3 times. Gait variability of spatial and temporal gait variables (stride time, stride length, double support time and step width) will be measured and the coefficient of variation calculated (CV = (standard deviation / mean) x 100).

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  62. Change in dual-task gait

    Participants will perform three walks, once each under the following dual-task conditions: walking while naming animals, counting backwards from 100 by 1's, and counting backwards from 100 by 7's.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  63. Change in Sit to Stand Test (STST) performance

    Participants will be asked to sit and stand, from a chair, repetitively for 60 seconds.

    Measured: Baseline, post-intervention at 4 months, and follow-up at 10 months

  64. Biomarkers of Alzhiemer's Disease and Related Diseases

    A saliva sample will be taken to get a Polygenic Hazard Score is derived from a panel of 31 single nucleotide polymorphisms. The genetic content known as DNA, or deoxyribonucleic acid, will be analyzed in order to learn about genetic information that may increase a person's risk for developing dementia. This test is part of the overall outcome measure and is not a diagnostic test. Study participants will not receive results of this test. This test is not currently a standard of normal clinical care and is still under research to determine its utility in clinical practice.

    Measured: Post intervention, at 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2021
  2. Study start28 Jul 2021
  3. Primary completion8 Mar 2023
  4. Study completion27 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
2x2 factorial design
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04997681
Sponsor's protocol ID
SYNH001
Acronym
SYNERGIC@Hom
Status last verified
Sep 2023
First submitted
1 Jun 2021
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified IPD will be stored on a secure server called LORIS (Longitudinal Online Research and Imaging System) at the McGill Centre for Integrative Neuroscience, McGill University, Montreal, Quebec.

Publications

  • Omar H, Yetman L, Tranchant CC, Gallibois M, Hache JC, Faig K, Handrigan G, McGibbon C, Jarrett P. "It's About Connections": A Grounded Theory of Older Adults' Engagement in Remotely Delivered Home-Based Physical and Cognitive Exercise Interventions Aiming to Reduce the Risk of Dementia. J Patient Exp. 2025 Oct 30;12:23743735251392324. doi: 10.1177/23743735251392324. eCollection 2025.

    PubMed 41180905

  • Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

    PubMed 39360568

  • McGibbon C, Jarrett P, Handrigan G, Bouchard D, Tranchant CC, Sexton AM, Yetman L, Robinson B, Crapoulet S, Chamard-Witkowski L, Liu-Ambrose T, Middleton LE, Almeida QJ, Bherer L, Lim A, Speechley M, Kamkar N, Montero Odasso M; Canadian Consortium on Neurodegeneration in Aging (CCNA), CAN-THUMBS UP Group. Protocol for SYNchronising Exercises, Remedies in GaIt and Cognition at Home (SYNERGIC@Home): feasibility of a home-based double-blind randomised controlled trial to improve gait and cognition in individuals at risk for dementia. BMJ Open. 2022 Mar 31;12(3):e059988. doi: 10.1136/bmjopen-2021-059988.

    PubMed 35361653

Questions about this trial

What is this clinical trial studying?

A study testing Combined Aerobic Exercise and Resistance Training (AE + RT) and Cognitive Training (NeuropeakTM) in people with Mild Cognitive Impairment, run by University of New Brunswick at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention Adherence (time frame: Post-intervention at 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04997681, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

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