Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription
Not Applicable
Active, not recruiting
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: Aerobic TrainingBehavioral: Resistance TrainingBehavioral: Balance and Tone Training
- Registration Number
- NCT02737878
- Lead Sponsor
- University of British Columbia
- 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 be done for a sub-set of participants.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 216
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Aerobic Training and Resistance Training (A&RT) Resistance Training The A\&RT program will be a four-times-per week program. Twice a week will be aerobic training consisting of outdoor walks with certified fitness instructors. The outdoor walking program will start participants out working at 45% of their heart rate reserve, and work up to 70% of the heart rate reserve. The other two days a week will be resistance training in which a pressurized air system and free weights will be used to provide the training stimulus. Other key strength exercises (with free weights) will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method, when 2 sets of 6-8 repetitions are completed with proper form. Aerobic Training (AT) Aerobic Training The AT program will be a four-times-per week program. Twice a week will be aerobic training consisting of outdoor walks with certified fitness instructors. The outdoor walking program will start participants out working at 45% of their heart rate reserve, and work up to 70% of the heart rate reserve. The other two days per week are a balance and tone program consisting of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises. Aerobic Training (AT) Balance and Tone Training The AT program will be a four-times-per week program. Twice a week will be aerobic training consisting of outdoor walks with certified fitness instructors. The outdoor walking program will start participants out working at 45% of their heart rate reserve, and work up to 70% of the heart rate reserve. The other two days per week are a balance and tone program consisting of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises. Aerobic Training and Resistance Training (A&RT) Aerobic Training The A\&RT program will be a four-times-per week program. Twice a week will be aerobic training consisting of outdoor walks with certified fitness instructors. The outdoor walking program will start participants out working at 45% of their heart rate reserve, and work up to 70% of the heart rate reserve. The other two days a week will be resistance training in which a pressurized air system and free weights will be used to provide the training stimulus. Other key strength exercises (with free weights) will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method, when 2 sets of 6-8 repetitions are completed with proper form. Balance and Tone Program (CON) Balance and Tone Training The CON program will be a four-times-per week program. The CON group will consist of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises. Resistance Training (RT) Resistance Training The RT program will be a four-times-per week program. Twice a week will be resistance training in which a pressurized air system and free weights will be used to provide the training stimulus. Other key strength exercises (with free weights) will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method, when 2 sets of 6-8 repetitions are completed with proper form. The other two days per week are a balance and tone program consisting of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises. Resistance Training (RT) Balance and Tone Training The RT program will be a four-times-per week program. Twice a week will be resistance training in which a pressurized air system and free weights will be used to provide the training stimulus. Other key strength exercises (with free weights) will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method, when 2 sets of 6-8 repetitions are completed with proper form. The other two days per week are a balance and tone program consisting of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises.
- Primary Outcome Measures
Name Time Method Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) Baseline to 6 months Cognition
- Secondary Outcome Measures
Name Time Method Cardiometabolic risk factors as measured by blood panel Baseline and 6 months Cardiometabolic risk factors
Cortisol levels through saliva samples (subset) 5 times from baseline to 6 months Cortisol levels
Neurotrophic factors as measured by blood Baseline and 6 months Neurotrophic factors
Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) Baseline and 6 months Depressive symptoms
Diffusion tensor imaging as measured by magnetic resonance imaging Baseline and 6 months White matter integrity
Cardiorespiratory capacity as measured by treadmill test Baseline and 6 months Cardiovascular fitness
Cardiometabolic risk as measured by pulse wave velocity (arterial stiffness) Baseline and 6 months Cardiometabolic risk
Body composition as measured by DXA Baseline and 6 months Body composition
Sedentary behaviour as measure by the Sedentary Behaviour Questionnaire Baseline, 3 months, 6 months, 12 months, and 18 months Sedentary behaviour
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
Social network as measured by Lubben Social Network Scale Baseline and 6 months Social network
Mood as measured by the State and Trait Anxiety Inventory Baseline and 6 months and 18 months Mood
Brain function as measured by functional magnetic resonance imaging (fMRI) Baseline and 6 months Brain function
Cardiometabolic risk as measured by body mass index Baseline and 6 months and 18 months. Cardiometabolic risk
Executive functions as measured by standard neuropsychological and computerized tests Baseline and 6 months and 18 months Executive functions
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
Brain structure as measured by structural magnetic resonance imaging Baseline and 6 months Brain structure
Lower body strength as measured by Biodex Baseline and 6 months Lower body strength
Sleep quality as measured by Motion Watch actigraphy Baseline and 6 months Sleep quality
Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale - 13 items Baseline and 6 months and 18 months Cognitive function
Memory as measured by the Everyday Memory Questionnaire Baseline and 6 months Memory
White matter lesion volume as measured by magnetic resonance imaging Baseline and 6 months White matter lesion
Visualspatial ability as measured by standard neuropsychological and computerized tests Baseline and 6 months Visualspatial ability
Mobility as measured by 400-m walk Baseline and 6 months and 18 months Mobility
Mobility as measured by Short Physical Performance Battery Baseline and 6 months and 18 months Mobility
Loneliness as measured by the UCLA Loneliness Scale Baseline and 6 months Loneliness
ADAS-Cog Plus 18 months Cognitive function
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
Physical activity level (i.e., amount of light, moderate, and vigorous) measured by Motion Watch actigraphy Baseline and 6 months Physical activity levels
Quality of life measured by EQ-5D-5L Baseline, 3 months, 6 months, and 18 months Quality of life
Telemere length Baseline and 6 months Marker of aging
Memory as measured by standard neuropsychological and computerized tests Baseline and 6 months and 18 months Memory
Cardiometabolic risk as measured by waist to hip ratio Baseline and 6 months and 18 months Cardiometabolic risk
Lower body strength as measured by the 30 sec sit-to-stand (subset) Baseline and 6 months and 18 months Lower body strength
Upper body strength as measured by grip strength Baseline and 6 months Upper body strength
Community mobility as measured by the Life Space Questionnaire Baseline, 3 months, 6 months, 12 months, and 18 months Mobility
Risk of sleep apnea as measured by the STOP Bang Questionnaire Baseline and 6 months Sleep apnea risk
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
Physical activity as measured by the CHAMP Questionnaire Baseline and 3 months and 6 months and monthly Physical Activity Level
Health resource utilization (e.g., access health system services/resources) Baseline, 3 months, and 6 months Access health system services/resources
Sedentary behaviour (i.e., less than = or less than1.5 mets of activity) measured by Motion Watch actigraphy Baseline and 6 months Sedentary behaviour
Verbal memory and learning using the Rey Auditory Verbal Learning Test Baseline, 6 months, and 18 months Verbal memory and learning
Dual-task gait using Gaitrite Baseline and 6 months Dual-task walking
Wellbeing measured by ICE-CAP Baseline, 3 months, 6 months, and 18 months Wellbeing
Trial Locations
- Locations (1)
University of British Columbia
šØš¦Vancouver, British Columbia, Canada