Mild Cognitive Impairment
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAerobic Training
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.
BEHAVIORALResistance Training
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.
BEHAVIORALBalance and Tone Training
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.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) | Baseline to 6 months | Cognition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurotrophic factors as measured by blood | Baseline and 6 months | Neurotrophic factors |
| Mobility as measured by Short Physical Performance Battery | Baseline and 6 months and 18 months | Mobility |
| Community mobility as measured by the Life Space Questionnaire | Baseline, 3 months, 6 months, 12 months, and 18 months | Mobility |
| Body composition as measured by DXA | Baseline and 6 months | Body composition (lean \& fat mass) |
| Loneliness as measured by the UCLA Loneliness Scale | Baseline and 6 months | Loneliness |
| Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale - 13 items | Baseline and 6 months and 18 months | Cognitive function |
| Executive functions as measured by standard neuropsychological and computerized tests | Baseline and 6 months and 18 months | Executive functions |
| Intraindividual variability (IIV) in executive functions as measured by the NIH ToolBox Cognitive Battery | Baseline and 6 months and 18 months | IIV of executive functions |
| Cardiometabolic risk factors as measured by blood panel | Baseline and 6 months | Cardiometabolic risk factors |
| Health related quality of life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L) | Baseline, 3 months, 6 months, 12 months, and 18 months | Quality of life |
| Health related quality of life as measured by the ICE-CAP | Baseline, 3 months, 6 months, 12 months, and 18 months | Quality of life |
| Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline and 6 months | Depressive symptoms |
| Brain function as measured by functional magnetic resonance imaging (fMRI) | Baseline and 6 months | Brain function |
| Brain structure as measured by structural magnetic resonance imaging | Baseline and 6 months | Brain structure |
| White matter lesion volume as measured by magnetic resonance imaging | Baseline and 6 months | White matter lesion |
| Diffusion tensor imaging as measured by magnetic resonance imaging | Baseline and 6 months | White matter integrity |
| Memory as measured by standard neuropsychological and computerized tests | Baseline and 6 months and 18 months | Memory |
| Intraindividual variability (IIV) in memory as measured by the NIH ToolBox Cognitive Battery | Baseline and 6 months and 18 months | IIV of memory |
| Visualspatial ability as measured by standard neuropsychological and computerized tests | Baseline and 6 months | Visualspatial ability |
| Cardiorespiratory capacity as measured by treadmill test | Baseline and 6 months | Cardiovascular fitness |
| Mobility as measured by 400-m walk | Baseline and 6 months and 18 months | Mobility |
| Cardiorespiratory capacity esimated from 400-m walk | Baseline and 6 months and 18 months | Estimated cardiovascular fitness |
| Cardiometabolic risk as measured by waist to hip ratio | Baseline and 6 months and 18 months | Cardiometabolic risk |
| Cardiometabolic risk as measured by body mass index | Baseline and 6 months and 18 months. | Cardiometabolic risk |
| Cardiometabolic risk as measured by pulse wave velocity (arterial stiffness) | Baseline and 6 months | Cardiometabolic risk |
| Cortisol levels through saliva samples (subset) | 5 times from baseline to 6 months | Cortisol levels |
| Lower body strength as measured by the 30 sec sit-to-stand (subset) | Baseline and 6 months and 18 months | Lower body strength |
| Lower body strength as measured by Biodex | Baseline and 6 months | Lower body strength |
| Upper body strength as measured by grip strength | Baseline and 6 months | Upper body strength |
| Sedentary behaviour as measure by the Sedentary Behaviour Questionnaire | Baseline, 3 months, 6 months, 12 months, and 18 months | Sedentary behaviour |
| Risk of sleep apnea as measured by the STOP Bang Questionnaire | Baseline and 6 months | Sleep apnea risk |
| Prospective falls via Monthly Calendars | Baseline and 3 months and 6 months and monthly | Accidental falls |
| Social support as measured by Social Provision Scale | Baseline and 6 months | Social support |
| Mindfulness as measured by the Mindfulness Attention Awareness Scale | Baseline and 6 months | Mindfulness |
| Memory as measured by the Everyday Memory Questionnaire | Baseline and 6 months | Memory |
| Sleep as measured by the Pittsburgh Sleep Quality Index | Baseline, 6 months, 12 months, and 18 months | Sleep |
| Functional ability as measured by the Lawson IADL | Baseline and 6 months | Instrumental activities of daily living |
| Comorbidities as measured by the Function Comorbidity Index | Baseline, 6 months, 12 months, and 18 months | Chronic conditions |
| Mood as measured by the State and Trait Anxiety Inventory | Baseline and 6 months and 18 months | Mood |
| Social network as measured by Lubben Social Network Scale | Baseline and 6 months | Social network |
| Physical activity as measured by the CHAMP Questionnaire | Baseline and 3 months and 6 months and monthly | Physical Activity Level |
| ADAS-Cog Plus | 18 months | Cognitive function |
| Verbal memory and learning using the Rey Auditory Verbal Learning Test | Baseline, 6 months, and 18 months | Verbal memory and learning |
| Verbal fluency (categorial of animals and semantic using F,A,S) | Baseline, 6 months, and 18 months | Verbal functioning tests requiring retrieval |
| Cytokines - proteins involved in immune response, as measured by blood | Baseline and 6 months | Cytokines |
| Dual-task gait using Gaitrite | Baseline and 6 months | Dual-task walking |
| Health resource utilization (e.g., access health system services/resources) | Baseline, 3 months, and 6 months | Access health system services/resources |
| Physical activity level (i.e., amount of light, moderate, and vigorous) measured by Motion Watch actigraphy | Baseline and 6 months | Physical activity levels |
| Sedentary behaviour (i.e., less than = or less than1.5 mets of activity) measured by Motion Watch actigraphy | Baseline and 6 months | Sedentary behaviour |
| Quality of life measured by EQ-5D-5L | Baseline, 3 months, 6 months, and 18 months | Quality of life |
| Wellbeing measured by ICE-CAP | Baseline, 3 months, 6 months, and 18 months | Wellbeing |
| Telemere length | Baseline and 6 months | Marker of aging |
| Gait speed over 4-m walk | Baseline, 6 months, and 18 months | Gait Speed |
| Sleep quality as measured by Motion Watch actigraphy | Baseline and 6 months | Sleep quality |
| Brain Age as derived from T1 structural scans | Basline and 6 months | Brain Age |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORTeresa Liu-Ambrose, PhD, PT
University of British Columbia
PRINCIPAL_INVESTIGATORJohn Best, PhD
University of British Columbia
PRINCIPAL_INVESTIGATORJennifer Davis, PhD
University of British Columbia
PRINCIPAL_INVESTIGATORLara Boyd, PhD
University of British Columbia
PRINCIPAL_INVESTIGATORLiisa Galea, PhD
University of British Columbia
PRINCIPAL_INVESTIGATORCharlie Goldsmith, PhD
Simon Fraser University
PRINCIPAL_INVESTIGATORGing-Yuek Robin Hsiung, MD, PhD
University of British Columbia
PRINCIPAL_INVESTIGATORAlexander MacKay, PhD
University of British Columbia
PRINCIPAL_INVESTIGATORLindsay Nagamatsu, PhD
Western University
PRINCIPAL_INVESTIGATORClaudia Jacova, PhD
Pacific University
PRINCIPAL_INVESTIGATORArthur Kramer, PhD
Northeastern University
PRINCIPAL_INVESTIGATORMichelle Voss, PhD
University of Iowa
PRINCIPAL_INVESTIGATORCindy Barha, PhD
University of British Columbia
PRINCIPAL_INVESTIGATORJoel Singer, PhD
University of British Columbia
Outcome results
None listed