Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription

University of British Columbia226 enrolled

Overview

Dementia is one of the most pressing health care issues of the 21st century. Evidence suggests that exercise enhances cognitive function in healthy older adults. Most research has focused on aerobic training (AT). Therefore, investigators aim to assess the individual effects of AT and resistance training (RT), as well as the interaction effect of combining the two types of exercise training, on cognitive function in older adults with mild cognitive impairment.

Investigators will conduct a 6-month assessor-blinded randomized-controlled trial of 216 community-dwelling adults with mild cognitive impairment. Individuals will be randomized to one of four experimental groups, all which receive 6 months of exercise classes four times per week: 1) combined aerobic training and resistance training; 2) aerobic training; 3) resistance training; or 4) balance and toning exercise. There will be two measurement sessions: baseline and 6 months (end of intervention period). A 12-month followup (i.e., 18 months from baseline) measurement will also be done.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

226

Conditions

Mild Cognitive Impairment

Interventions

Aerobic TrainingBEHAVIORAL

Six months of twice-weekly aerobic training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down). To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of wearables to monitor heart rate. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

Resistance TrainingBEHAVIORAL

Six months of twice-weekly resistance training program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down). To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of a set of resistance bands of various weights. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

Eligibility

Sex: ALLMin age: 65 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Community-dwelling in Metro Vancouver * Have subjective memory complaints, defined as the self-reported feeling of memory worsening with an onset within the last 5 years, as determined by interview and corroborated by an informant * Have a baseline Montreal Cognitive Assessment (MoCA) score \< 26/30 * Mini-Mental State Examination (MMSE) score = or \> 22 at screening * Read, write, and speak English * Not expected to start or are stable on a fixed dose of anti-dementia medications (e.g., donepezil, galantamine, etc.) during the 6-month intervention period * Able to walk independently * Must be in sufficient health to participate in the exercise programs * Able to comply with scheduled visits, treatment plan, and other trial procedures * Provide a personally signed and dated informed consent document indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. In addition, an assent form will be provided at baseline and again at regular intervals Exclusion Criteria: * Engaged in moderate (e.g., brisk walking) physical activity \> 1 time per week, or \> 60 minutes per week, in the 3 months prior to study entry * Diagnosed with dementia of any type * Clinically suspected to have neurodegenerative disease as the cause of mild cognitive impairment (MCI) that is not Alzheimer's Disease (AD), vascular cognitive impairment (VCI), or both (e.g., multiple sclerosis, Parkinson's disease, Huntington's disease, frontotemporal dementia) * At high risk for cardiac complications during exercise or unable to self-regulate activity or to understand recommended activity level; 5) have clinically important peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician * Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (i.e., typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid) * On any hormone therapy (estrogen, progesterone, or testosterone) in the last 24 months * Planning to participate, or already enrolled in, a concurrent clinical drug or exercise trial

Locations (1)

University of British Columbia

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus)

Cognition

Time frame: Baseline to 6 months

Secondary Outcomes

Executive functions as measured by standard neuropsychological and computerized tests

Executive functions

Time frame: Baseline and 6 months and 18 months

Intraindividual variability (IIV) in executive functions as measured by the NIH ToolBox Cognitive Battery

IIV of executive functions

Time frame: Baseline and 6 months and 18 months

Cardiometabolic risk factors as measured by blood panel

Cardiometabolic risk factors

Time frame: Baseline and 6 months

Health related quality of life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L)

Quality of life

Time frame: Baseline, 3 months, 6 months, 12 months, and 18 months

Health related quality of life as measured by the ICE-CAP

Quality of life

Time frame: Baseline, 3 months, 6 months, 12 months, and 18 months

Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)

Depressive symptoms

Time frame: Baseline and 6 months

Brain function as measured by functional magnetic resonance imaging (fMRI)

Brain function

Data from ClinicalTrials.gov

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Six months of twice-weekly stretching and relaxation program that includes stretching exercises, range of motion exercises, basic core-strength/kegal exercises, static balance exrecises, functional strength exercises (e.g., sit to stand), and relaxation techniques. Each session will be 60 minutes. To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of small equipment (e.g., pilate ball). Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

Balance and Tone TrainingBEHAVIORAL

Time frame: Baseline and 6 months

Brain structure as measured by structural magnetic resonance imaging

Brain structure

Time frame: Baseline and 6 months

White matter lesion volume as measured by magnetic resonance imaging

White matter lesion

Time frame: Baseline and 6 months

Diffusion tensor imaging as measured by magnetic resonance imaging

White matter integrity

Time frame: Baseline and 6 months

Memory as measured by standard neuropsychological and computerized tests

Memory

Time frame: Baseline and 6 months and 18 months

Intraindividual variability (IIV) in memory as measured by the NIH ToolBox Cognitive Battery

IIV of memory

Time frame: Baseline and 6 months and 18 months

Visualspatial ability as measured by standard neuropsychological and computerized tests

Visualspatial ability

Time frame: Baseline and 6 months

Cardiorespiratory capacity as measured by treadmill test

Cardiovascular fitness

Time frame: Baseline and 6 months

Mobility as measured by 400-m walk

Mobility

Time frame: Baseline and 6 months and 18 months

Cardiorespiratory capacity esimated from 400-m walk

Estimated cardiovascular fitness

Time frame: Baseline and 6 months and 18 months

Cardiometabolic risk as measured by waist to hip ratio

Cardiometabolic risk

Time frame: Baseline and 6 months and 18 months

Cardiometabolic risk as measured by body mass index

Cardiometabolic risk

Time frame: Baseline and 6 months and 18 months.

Cardiometabolic risk as measured by pulse wave velocity (arterial stiffness)

Cardiometabolic risk

Time frame: Baseline and 6 months

Cortisol levels through saliva samples (subset)

Cortisol levels

Time frame: 5 times from baseline to 6 months

Lower body strength as measured by the 30 sec sit-to-stand (subset)

Lower body strength

Time frame: Baseline and 6 months and 18 months

Lower body strength as measured by Biodex

Lower body strength

Time frame: Baseline and 6 months

Upper body strength as measured by grip strength

Upper body strength

Time frame: Baseline and 6 months

Sleep quality as measured by Motion Watch actigraphy

Sleep quality

Time frame: Baseline and 6 months

Neurotrophic factors as measured by blood

Neurotrophic factors

Time frame: Baseline and 6 months

Mobility as measured by Short Physical Performance Battery

Mobility

Time frame: Baseline and 6 months and 18 months

Community mobility as measured by the Life Space Questionnaire

Mobility

Time frame: Baseline, 3 months, 6 months, 12 months, and 18 months

Body composition as measured by DXA

Body composition (lean \& fat mass)

Time frame: Baseline and 6 months

Loneliness as measured by the UCLA Loneliness Scale

Loneliness

Time frame: Baseline and 6 months

Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale - 13 items

Cognitive function

Time frame: Baseline and 6 months and 18 months

Sedentary behaviour as measure by the Sedentary Behaviour Questionnaire

Sedentary behaviour

Time frame: Baseline, 3 months, 6 months, 12 months, and 18 months

Risk of sleep apnea as measured by the STOP Bang Questionnaire

Sleep apnea risk

Time frame: Baseline and 6 months

Prospective falls via Monthly Calendars

Accidental falls

Time frame: Baseline and 3 months and 6 months and monthly

Social support as measured by Social Provision Scale

Social support

Time frame: Baseline and 6 months

Mindfulness as measured by the Mindfulness Attention Awareness Scale

Mindfulness

Time frame: Baseline and 6 months

Memory as measured by the Everyday Memory Questionnaire

Memory

Time frame: Baseline and 6 months

Sleep as measured by the Pittsburgh Sleep Quality Index

Sleep

Time frame: Baseline, 6 months, 12 months, and 18 months

Functional ability as measured by the Lawson IADL

Instrumental activities of daily living

Time frame: Baseline and 6 months

Comorbidities as measured by the Function Comorbidity Index

Chronic conditions

Time frame: Baseline, 6 months, 12 months, and 18 months

Mood as measured by the State and Trait Anxiety Inventory

Mood

Time frame: Baseline and 6 months and 18 months

Social network as measured by Lubben Social Network Scale

Social network

Time frame: Baseline and 6 months

Physical activity as measured by the CHAMP Questionnaire

Physical Activity Level

Time frame: Baseline and 3 months and 6 months and monthly

ADAS-Cog Plus

Cognitive function

Time frame: 18 months

Verbal memory and learning using the Rey Auditory Verbal Learning Test

Verbal memory and learning

Time frame: Baseline, 6 months, and 18 months

Verbal fluency (categorial of animals and semantic using F,A,S)

Verbal functioning tests requiring retrieval

Time frame: Baseline, 6 months, and 18 months

Cytokines - proteins involved in immune response, as measured by blood

Cytokines

Time frame: Baseline and 6 months

Dual-task gait using Gaitrite

Dual-task walking

Time frame: Baseline and 6 months

Health resource utilization (e.g., access health system services/resources)

Access health system services/resources

Time frame: Baseline, 3 months, and 6 months

Physical activity level (i.e., amount of light, moderate, and vigorous) measured by Motion Watch actigraphy

Physical activity levels

Time frame: Baseline and 6 months

Sedentary behaviour (i.e., less than = or less than1.5 mets of activity) measured by Motion Watch actigraphy

Sedentary behaviour

Time frame: Baseline and 6 months

Quality of life measured by EQ-5D-5L

Quality of life

Time frame: Baseline, 3 months, 6 months, and 18 months

Wellbeing measured by ICE-CAP

Wellbeing

Time frame: Baseline, 3 months, 6 months, and 18 months

Telemere length

Marker of aging

Time frame: Baseline and 6 months

Gait speed over 4-m walk

Gait Speed

Time frame: Baseline, 6 months, and 18 months

Brain Age as derived from T1 structural scans

Brain Age

Time frame: Basline and 6 months