Clinical trial NCT04997681: SYNchronizing Exercises, Remedies in Gait and Cognition at Home (SYNERGIC@Home)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Exercise
Cognitive training
Intervention preference
Elderly
Gait
Dementia
Home-based intervention
Cognitive impairment
Lead sponsor: University of New Brunswick
Sponsor class: OTHER
Collaborators: name: Horizon Health Network
name: Réseau de Santé Vitalité Health Network
name: Universite de Moncton
name: Western University, Canada
First posted: 2021-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design
Primary purpose: PREVENTION

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Adherence
timeFrame: Post-intervention at 4 months
measure: Intervention Preference
timeFrame: Baseline
Secondary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, an average of 10 months
measure: Retention Rate
timeFrame: Through study completion, an average of 10 months
measure: Assessment Tolerability
timeFrame: Baseline
measure: Trial Experience
timeFrame: 10 months follow-up
measure: Adverse Events
timeFrame: Monitored from start of study until end of study
measure: Height
timeFrame: Baseline
measure: Data Loss
timeFrame: Through study completion, an average of 10 months
measure: Weight
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Change in Hip Circumference
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Neck Circumference
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in waist circumference
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in blood pressure
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in heart rate
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Medications
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Chronic Diseases
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in fall history
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Health Status and Self-Perception
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Constant Fatigue
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Falls and Balance
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Vision
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Hearing
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Nutrition
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Sleep
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Mayo Fluctuation Scale
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Telephone Cognitive Screen (TCogS)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Clinical Dementia Rating Scale (CDR)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in remote version of the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) scale
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in ADAS-Cog Immediate Word Recall
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in ADAS-Cog Delayed Word Recall
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in ADAS-Cog Orientation
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Cognitive Functional Composite 2 (CFC-2)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Functional Activities Questionnaire
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Oral Trail Making Test (TMT) A
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Oral Trail Making Test (TMT) B
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in 15-item Boston Naming Test (BNT)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Logical Memory I
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Logical Memory II
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in ADAS-Cog Word Recognition
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in The Delis-Kaplan Executive Function System (DKEFS) phonemic fluency test
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in The Delis-Kaplan Executive Function System (DKEFS) semantic fluency test
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Digit Span Backward Test
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Oral version of the Digit Symbol Modalities Test
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in 18-item Pittsburgh Sleep Quality Index (PSQI-18)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Work and Sleep Diary (WSD)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in 14-item Mediterranean Diet Assessment (MDA-14)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Eating Pattern Self-Assessment
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Questionnaire for Vitamin D intake
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Physical Activity Scale for the Elderly (PASE)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Life Space Questionnaire (LSQ)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Clinical Frailty Scale (CFS)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Short Form quality of life questionnaire (SF-36)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: COVID-19 Questionnaire
timeFrame: Baseline
measure: Change in Generalized Anxiety Disorder 7 (GAD 7)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Geriatric Depression Scale (GDS-30)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Short Test of Functional Health Literacy in Adults (STOFHLA)
timeFrame: Baseline
measure: Change in Functional Assessment of Currently Employed Technology Scale (FACETS)
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in seated dual task
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in single-task gait
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in dual-task gait
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Change in Sit to Stand Test (STST) performance
timeFrame: Baseline, post-intervention at 4 months, and follow-up at 10 months
measure: Biomarkers of Alzhiemer's Disease and Related Diseases
timeFrame: Post intervention, at 8 months
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: The University of New Brunswick
state: New Brunswick
Study officials:
affiliation: University of New Brunswick
name: Chris McGibbon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.