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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- University of New Brunswick
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Intervention Adherence
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Chris A. McGibbon, PhD
Professor
University of New Brunswick
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:
- •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).
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.
Outcomes
Primary Outcomes
Intervention Adherence
Time Frame: Post-intervention at 4 months
Defined as the mean percent of all Intervention sessions attended of the 48 planned sessions per participant.
Intervention Preference
Time Frame: Baseline
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
Secondary Outcomes
- Adverse Events(Monitored from start of study until end of study)
- Sex(Baseline)
- Age(Baseline)
- Recruitment Rate(Through study completion, an average of 10 months)
- Weight(Baseline)
- Chronic Diseases(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Assessment Tolerability(Baseline)
- Height(Baseline)
- Data Loss(Through study completion, an average of 10 months)
- Change in Neck Circumference(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in waist circumference(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Medications(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Vision(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Falls and Balance(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Retention Rate(Through study completion, an average of 10 months)
- Trial Experience(10 months follow-up)
- Change in Hip Circumference(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in heart rate(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in fall history(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Constant Fatigue(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Hearing(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Clinical Dementia Rating Scale (CDR)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in remote version of the Montreal Cognitive Assessment (MoCA)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in ADAS-Cog Orientation(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in blood pressure(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Nutrition(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Mayo Fluctuation Scale(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Lawton-Brody Instrumental Activities of Daily Living (IADL) scale(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in ADAS-Cog Delayed Word Recall(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Oral Trail Making Test (TMT) A(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Logical Memory I(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Digit Span Backward Test(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Cognitive Functional Composite 2 (CFC-2)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Health Status and Self-Perception(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Sleep(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Telephone Cognitive Screen (TCogS)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Oral Trail Making Test (TMT) B(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in 15-item Boston Naming Test (BNT)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Logical Memory II(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Oral version of the Digit Symbol Modalities Test(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in 18-item Pittsburgh Sleep Quality Index (PSQI-18)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Work and Sleep Diary (WSD)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Eating Pattern Self-Assessment(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in ADAS-Cog Immediate Word Recall(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Functional Activities Questionnaire(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in 14-item Mediterranean Diet Assessment (MDA-14)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Questionnaire for Vitamin D intake(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in single-task gait(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Sit to Stand Test (STST) performance(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in ADAS-Cog Word Recognition(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in The Delis-Kaplan Executive Function System (DKEFS) phonemic fluency test(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Clinical Frailty Scale (CFS)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Short Form quality of life questionnaire (SF-36)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Short Test of Functional Health Literacy in Adults (STOFHLA)(Baseline)
- Change in The Delis-Kaplan Executive Function System (DKEFS) semantic fluency test(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Physical Activity Scale for the Elderly (PASE)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Life Space Questionnaire (LSQ)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- COVID-19 Questionnaire(Baseline)
- Change in Generalized Anxiety Disorder 7 (GAD 7)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Biomarkers of Alzhiemer's Disease and Related Diseases(Post intervention, at 8 months)
- Change in Geriatric Depression Scale (GDS-30)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in Functional Assessment of Currently Employed Technology Scale (FACETS)(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in dual-task gait(Baseline, post-intervention at 4 months, and follow-up at 10 months)
- Change in seated dual task(Baseline, post-intervention at 4 months, and follow-up at 10 months)