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

University of New Brunswick

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Control Balance and Toning Exercise Training (BAT); Behavioral: Control Cognitive Training of Website Searching and Video Watching (WS+V); Behavioral: Cognitive Training (NeuropeakTM); Behavioral: Combined Aerobic Exercise and Resistance Training (AE + RT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04997681

SYNH001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

• 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:

  1. 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).

  2. Subjective Cognitive Impairment (SCI) Group. Diagnosis of Subjective Cognitive Impairment, in accordance with the COMPASS-ND study2 definition (Table 1).

  3. 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.

Exclusion criteria

• 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.
• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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60 participants in 4 patient groups, including a placebo group

Exercise Intervention Training and Cognitive Intervention Training

Experimental group

Description:

Combined Aerobic Exercise and Resistance Training (AE + RT) + Cognitive Training (NeuropeakTM)

Treatment:

Behavioral: Combined Aerobic Exercise and Resistance Training (AE + RT)

Behavioral: Cognitive Training (NeuropeakTM)

Exercise Intervention Training and Control Cognitive Training

Active Comparator group

Description:

Combined Aerobic Exercise and Resistance Training (AE + RT) + Control Cognitive Training of Website Searching and Video Watching (WS+V)

Treatment:

Behavioral: Control Cognitive Training of Website Searching and Video Watching (WS+V)

Behavioral: Combined Aerobic Exercise and Resistance Training (AE + RT)

Control Exercise Training and Cognitive Intervention Training

Active Comparator group

Description:

Control Balance and Toning Exercise Training (BAT) + Cognitive Training (NeuropeakTM)

Treatment:

Behavioral: Control Balance and Toning Exercise Training (BAT)

Behavioral: Cognitive Training (NeuropeakTM)

Control Exercise Training and Control Cognitive Training

Placebo Comparator group

Description:

Control Balance and Toning Exercise Training (BAT) + Control Cognitive Training of Website Searching and Video Watching (WS+V)

Treatment:

Behavioral: Control Balance and Toning Exercise Training (BAT)

Behavioral: Control Cognitive Training of Website Searching and Video Watching (WS+V)