Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription: Understanding Training Type and Exploring Mechanisms
Overview
- Phase
- Not Applicable
- Intervention
- Aerobic Training
- Conditions
- Mild Cognitive Impairment
- Sponsor
- University of British Columbia
- Enrollment
- 226
- Locations
- 1
- Primary Endpoint
- Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus)
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
Teresa Liu-Ambrose
Principal Investigator
University of British Columbia
Eligibility Criteria
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
Arms & Interventions
Aerobic Training and Resistance Training (AT&RT)
The AT\&RT program will be a four-times-per week program. Twice a week will be aerobic training (AT) with a series of standardized AT exercise stations. Participants rotate through each station within the 40-min training duration with approx. 1-min rest between stations. Participants will exercise initially at approximately 50% of their age specific target heart rate reserve and gradually progress to reach the target of 80% of HRR. The other two days a week will be resistance training (RT) in which a pressurized air system and free weights will be used to provide the training stimulus. The initial intensity of the training stimulus will be set to a weight where participants can complete 2 sets of 10-15 repetitions. Training intensity will then progress on a cyclic basis from 45 to 85% of predicted 1 repetition maximum (1RM) as determined at week 6 using an 8-repetition maximum (8RM) test. Every 4 weeks, the 8RM test is repeated and the cycle repeats.
Intervention: Aerobic Training
Aerobic Training and Resistance Training (AT&RT)
The AT\&RT program will be a four-times-per week program. Twice a week will be aerobic training (AT) with a series of standardized AT exercise stations. Participants rotate through each station within the 40-min training duration with approx. 1-min rest between stations. Participants will exercise initially at approximately 50% of their age specific target heart rate reserve and gradually progress to reach the target of 80% of HRR. The other two days a week will be resistance training (RT) in which a pressurized air system and free weights will be used to provide the training stimulus. The initial intensity of the training stimulus will be set to a weight where participants can complete 2 sets of 10-15 repetitions. Training intensity will then progress on a cyclic basis from 45 to 85% of predicted 1 repetition maximum (1RM) as determined at week 6 using an 8-repetition maximum (8RM) test. Every 4 weeks, the 8RM test is repeated and the cycle repeats.
Intervention: Resistance Training
Aerobic Training (AT)
The AT program will be a four-times-per week program. Twice a week will be AT with a series of standardized AT exercise stations (e.g., treadmills, stationary cycles, aerobic steppers, agility ladders). Participants rotate through each station within the 40-min training duration with approx. 1-min rest between stations. Participants will exercise initially at approximately 50% of their age specific target heart rate reserve and gradually progress to reach the target of 80% of HRR. The other two days per week will be a balance and tone (CON) program consisting of 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. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.
Intervention: Aerobic Training
Aerobic Training (AT)
The AT program will be a four-times-per week program. Twice a week will be AT with a series of standardized AT exercise stations (e.g., treadmills, stationary cycles, aerobic steppers, agility ladders). Participants rotate through each station within the 40-min training duration with approx. 1-min rest between stations. Participants will exercise initially at approximately 50% of their age specific target heart rate reserve and gradually progress to reach the target of 80% of HRR. The other two days per week will be a balance and tone (CON) program consisting of 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. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.
Intervention: Balance and Tone Training
Resistance Training (RT)
The RT program will be a four-times-per week program. Twice a week will be RT in which a pressurized air system and free weights will be used to provide the training stimulus. The initial intensity of the training stimulus will be set to a weight where participants can complete 2 sets of 10-15 repetitions. Training intensity will then progress on a cyclic basis from 45 to 85% of predicted 1 RM as determined at week 6 using an 8RM test. Every 4 weeks, the 8RM test is repeated and the cycle repeats.The other two days per week will be a CON program consisting of 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. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.
Intervention: Resistance Training
Resistance Training (RT)
The RT program will be a four-times-per week program. Twice a week will be RT in which a pressurized air system and free weights will be used to provide the training stimulus. The initial intensity of the training stimulus will be set to a weight where participants can complete 2 sets of 10-15 repetitions. Training intensity will then progress on a cyclic basis from 45 to 85% of predicted 1 RM as determined at week 6 using an 8RM test. Every 4 weeks, the 8RM test is repeated and the cycle repeats.The other two days per week will be a CON program consisting of 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. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.
Intervention: Balance and Tone Training
Balance and Tone Program (CON)
The CON program will be a four-times-per week program. The CON group will consiste of 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. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.
Intervention: Balance and Tone Training
Outcomes
Primary Outcomes
Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus)
Time Frame: Baseline to 6 months
Cognition
Secondary Outcomes
- Executive functions as measured by standard neuropsychological and computerized tests(Baseline and 6 months and 18 months)
- Health related quality of life as measured by the ICE-CAP(Baseline, 3 months, 6 months, 12 months, and 18 months)
- Visualspatial ability as measured by standard neuropsychological and computerized tests(Baseline and 6 months)
- Cardiometabolic risk factors as measured by blood panel(Baseline and 6 months)
- Memory as measured by standard neuropsychological and computerized tests(Baseline and 6 months and 18 months)
- 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)
- Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline and 6 months)
- Brain function as measured by functional magnetic resonance imaging (fMRI)(Baseline and 6 months)
- Brain structure as measured by structural magnetic resonance imaging(Baseline and 6 months)
- White matter lesion volume as measured by magnetic resonance imaging(Baseline and 6 months)
- Diffusion tensor imaging as measured by magnetic resonance imaging(Baseline and 6 months)
- Cardiorespiratory capacity as measured by treadmill test(Baseline and 6 months)
- Mobility as measured by 400-m walk(Baseline and 6 months and 18 months)
- Cardiorespiratory capacity esimated from 400-m walk(Baseline and 6 months and 18 months)
- Cardiometabolic risk as measured by waist to hip ratio(Baseline and 6 months and 18 months)
- Cardiometabolic risk as measured by body mass index(Baseline and 6 months and 18 months.)
- Cardiometabolic risk as measured by pulse wave velocity (arterial stiffness)(Baseline and 6 months)
- Cortisol levels through saliva samples (subset)(5 times from baseline to 6 months)
- Lower body strength as measured by the 30 sec sit-to-stand (subset)(Baseline and 6 months and 18 months)
- Lower body strength as measured by Biodex(Baseline and 6 months)
- Upper body strength as measured by grip strength(Baseline and 6 months)
- Sleep quality as measured by Motion Watch actigraphy(Baseline and 6 months)
- Neurotrophic factors as measured by blood(Baseline and 6 months)
- Mobility as measured by Short Physical Performance Battery(Baseline and 6 months and 18 months)
- Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale - 13 items(Baseline and 6 months and 18 months)
- Sedentary behaviour as measure by the Sedentary Behaviour Questionnaire(Baseline, 3 months, 6 months, 12 months, and 18 months)
- Community mobility as measured by the Life Space Questionnaire(Baseline, 3 months, 6 months, 12 months, and 18 months)
- Body composition as measured by DXA(Baseline and 6 months)
- Loneliness as measured by the UCLA Loneliness Scale(Baseline and 6 months)
- Risk of sleep apnea as measured by the STOP Bang Questionnaire(Baseline and 6 months)
- Prospective falls via Monthly Calendars(Baseline and 3 months and 6 months and monthly)
- Social support as measured by Social Provision Scale(Baseline and 6 months)
- Mindfulness as measured by the Mindfulness Attention Awareness Scale(Baseline and 6 months)
- Memory as measured by the Everyday Memory Questionnaire(Baseline and 6 months)
- Sleep as measured by the Pittsburgh Sleep Quality Index(Baseline, 6 months, 12 months, and 18 months)
- Functional ability as measured by the Lawson IADL(Baseline and 6 months)
- Comorbidities as measured by the Function Comorbidity Index(Baseline, 6 months, 12 months, and 18 months)
- Mood as measured by the State and Trait Anxiety Inventory(Baseline and 6 months and 18 months)
- Social network as measured by Lubben Social Network Scale(Baseline and 6 months)
- Physical activity as measured by the CHAMP Questionnaire(Baseline and 3 months and 6 months and monthly)
- ADAS-Cog Plus(18 months)
- Verbal memory and learning using the Rey Auditory Verbal Learning Test(Baseline, 6 months, and 18 months)
- Verbal fluency (categorial of animals and semantic using F,A,S)(Baseline, 6 months, and 18 months)
- Cytokines - proteins involved in immune response, as measured by blood(Baseline and 6 months)
- Dual-task gait using Gaitrite(Baseline and 6 months)
- Health resource utilization (e.g., access health system services/resources)(Baseline, 3 months, and 6 months)
- Physical activity level (i.e., amount of light, moderate, and vigorous) measured by Motion Watch actigraphy(Baseline and 6 months)
- Sedentary behaviour (i.e., less than = or less than1.5 mets of activity) measured by Motion Watch actigraphy(Baseline and 6 months)
- Quality of life measured by EQ-5D-5L(Baseline, 3 months, 6 months, and 18 months)
- Wellbeing measured by ICE-CAP(Baseline, 3 months, 6 months, and 18 months)
- Telemere length(Baseline and 6 months)
- Gait speed over 4-m walk(Baseline, 6 months, and 18 months)
- Brain Age as derived from T1 structural scans(Basline and 6 months)
- Intraindividual variability (IIV) in executive functions as measured by the NIH ToolBox Cognitive Battery(Baseline and 6 months and 18 months)
- Intraindividual variability (IIV) in memory as measured by the NIH ToolBox Cognitive Battery(Baseline and 6 months and 18 months)