Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aerobic Training and Resistance Training (A&RT) 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. |
Behavioral: Aerobic 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 compliance.
Behavioral: Resistance 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 compliance.
|
| Experimental: Aerobic Training (AT) 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. |
Behavioral: Aerobic 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 compliance.
Behavioral: Balance and Tone Training
Six months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. 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 compliance.
|
| Experimental: Resistance Training (RT) 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. |
Behavioral: Resistance 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 compliance.
Behavioral: Balance and Tone Training
Six months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. 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 compliance.
|
| Active Comparator: Balance and Tone Program (CON) 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. |
Behavioral: Balance and Tone Training
Six months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. 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 compliance.
Behavioral: Balance and Tone Training
Six months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. 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 compliance.
|
Outcome Measures
Primary Outcome Measures
- Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) [Baseline to 6 months]
Secondary Outcome Measures
- Executive functions as measured by standard neuropsychological and computerized tests [Baseline and 6 months]
- Cardiometabolic risk factors as measured by blood panel [Baseline and 6 months]
- Health related quality of life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L) [Baseline and 6 months]
- Health related quality of life as measured by the ICE-CAP [Baseline and 6 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]
- Memory as measured by standard neuropsychological and computerized tests [Baseline and 6 months]
- Visualspatial ability as measured by standard neuropsychological and computerized tests [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]
- Cardiometabolic risk as measured by waist to hip ratio [Baseline and 6 months]
- Cardiometabolic risk as measured by body mass index [Baseline and 6 months]
- Cardiometabolic risk as measured by pulse wave velocity (arterial stiffness) [Baseline and 6 months]
- Cortisol levels through saliva samples [5 times from baseline to 6 months]
- Lower body strength as measured by the 30 sec sit-to-stand [Baseline and 6 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 monitoring as measured by Motion Watch actigraphy [Baseline, 3 months, 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]
- Mobility as measured by the Life Space Questionnaire [Baseline and 6 months]
- Body composition as measured by DXA [Baseline and 6 months]
- Loneliness as measured by the UCLA Loneliness Scale [Baseline and 6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Community-dwelling in Metro Vancouver
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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
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Have a baseline Montreal Cognitive Assessment (MoCA) score < 26/30
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Mini-Mental State Examination (MMSE) score > 24 at screening
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Read, write, and speak English
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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
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Able to walk independently
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Must be in sufficient health to participate in the exercise programs
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Able to comply with scheduled visits, treatment plan, and other trial procedures
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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:
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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
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Diagnosed with dementia of any type
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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)
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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
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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)
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On any hormone therapy (estrogen, progesterone, or testosterone) in the last 24 months
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Planning to participate, or already enrolled in, a concurrent clinical drug or exercise trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of British Columbia | Vancouver | British Columbia | Canada | V5Z 1M9 |
Sponsors and Collaborators
- University of British Columbia
Investigators
- Principal Investigator: Teresa Liu-Ambrose, PhD, PT, University of British Columbia
- Principal Investigator: John Best, PhD, University of British Columbia
- Principal Investigator: Jennifer Davis, PhD, University of British Columbia
- Principal Investigator: Lara Boyd, PhD, University of British Columbia
- Principal Investigator: Liisa Galea, PhD, University of British Columbia
- Principal Investigator: Charlie Goldsmith, PhD, Simon Fraser University
- Principal Investigator: Ging-Yuek Robin Hsiung, MD, PhD, University of British Columbia
- Principal Investigator: Alexander MacKay, PhD, University of British Columbia
- Principal Investigator: Lindsay Nagamatsu, PhD, Western University
- Principal Investigator: Claudia Jacova, PhD, Pacific University
- Principal Investigator: Arthur Kramer, PhD, Northeastern University
- Principal Investigator: Michelle Voss, PhD, University of Iowa
- Principal Investigator: Cindy Barha, PhD, University of British Columbia
- Principal Investigator: Joel Singer, PhD, University of British Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H15-02181