- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02737878
Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription
Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription: Understanding Training Type and Exploring Mechanisms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nathan Wei, BSc
- Phone Number: 69313 604-875-4111
- Email: cogmob.research@hiphealth.ca
Study Contact Backup
- Name: Teresa Liu-Ambrose, PhD, PT
- Phone Number: 69059 604-875-4111
- Email: teresa.ambrose@ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- University of British Columbia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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. 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.
|
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. 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.
|
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. 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus)
Time Frame: Baseline to 6 months
|
Cognition
|
Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Executive functions as measured by standard neuropsychological and computerized tests
Time Frame: Baseline and 6 months and 18 months
|
Executive functions
|
Baseline and 6 months and 18 months
|
Cardiometabolic risk factors as measured by blood panel
Time Frame: Baseline and 6 months
|
Cardiometabolic risk factors
|
Baseline and 6 months
|
Health related quality of life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L)
Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months
|
Quality of life
|
Baseline, 3 months, 6 months, 12 months, and 18 months
|
Health related quality of life as measured by the ICE-CAP
Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months
|
Quality of life
|
Baseline, 3 months, 6 months, 12 months, and 18 months
|
Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Baseline and 6 months
|
Depressive symptoms
|
Baseline and 6 months
|
Brain function as measured by functional magnetic resonance imaging (fMRI)
Time Frame: Baseline and 6 months
|
Brain function
|
Baseline and 6 months
|
Brain structure as measured by structural magnetic resonance imaging
Time Frame: Baseline and 6 months
|
Brain structure
|
Baseline and 6 months
|
White matter lesion volume as measured by magnetic resonance imaging
Time Frame: Baseline and 6 months
|
White matter lesion
|
Baseline and 6 months
|
Diffusion tensor imaging as measured by magnetic resonance imaging
Time Frame: Baseline and 6 months
|
White matter integrity
|
Baseline and 6 months
|
Memory as measured by standard neuropsychological and computerized tests
Time Frame: Baseline and 6 months and 18 months
|
Memory
|
Baseline and 6 months and 18 months
|
Visualspatial ability as measured by standard neuropsychological and computerized tests
Time Frame: Baseline and 6 months
|
Visualspatial ability
|
Baseline and 6 months
|
Cardiorespiratory capacity as measured by treadmill test
Time Frame: Baseline and 6 months
|
Cardiovascular fitness
|
Baseline and 6 months
|
Mobility as measured by 400-m walk
Time Frame: Baseline and 6 months and 18 months
|
Mobility
|
Baseline and 6 months and 18 months
|
Cardiometabolic risk as measured by waist to hip ratio
Time Frame: Baseline and 6 months and 18 months
|
Cardiometabolic risk
|
Baseline and 6 months and 18 months
|
Cardiometabolic risk as measured by body mass index
Time Frame: Baseline and 6 months and 18 months.
|
Cardiometabolic risk
|
Baseline and 6 months and 18 months.
|
Cardiometabolic risk as measured by pulse wave velocity (arterial stiffness)
Time Frame: Baseline and 6 months
|
Cardiometabolic risk
|
Baseline and 6 months
|
Lower body strength as measured by Biodex
Time Frame: Baseline and 6 months
|
Lower body strength
|
Baseline and 6 months
|
Upper body strength as measured by grip strength
Time Frame: Baseline and 6 months
|
Upper body strength
|
Baseline and 6 months
|
Sleep quality as measured by Motion Watch actigraphy
Time Frame: Baseline and 6 months
|
Sleep quality
|
Baseline and 6 months
|
Neurotrophic factors as measured by blood
Time Frame: Baseline and 6 months
|
Neurotrophic factors
|
Baseline and 6 months
|
Mobility as measured by Short Physical Performance Battery
Time Frame: Baseline and 6 months and 18 months
|
Mobility
|
Baseline and 6 months and 18 months
|
Community mobility as measured by the Life Space Questionnaire
Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months
|
Mobility
|
Baseline, 3 months, 6 months, 12 months, and 18 months
|
Body composition as measured by DXA
Time Frame: Baseline and 6 months
|
Body composition
|
Baseline and 6 months
|
Loneliness as measured by the UCLA Loneliness Scale
Time Frame: Baseline and 6 months
|
Loneliness
|
Baseline and 6 months
|
Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale - 13 items
Time Frame: Baseline and 6 months and 18 months
|
Cognitive function
|
Baseline and 6 months and 18 months
|
Sedentary behaviour as measure by the Sedentary Behaviour Questionnaire
Time Frame: Baseline, 3 months, 6 months, 12 months, and 18 months
|
Sedentary behaviour
|
Baseline, 3 months, 6 months, 12 months, and 18 months
|
Risk of sleep apnea as measured by the STOP Bang Questionnaire
Time Frame: Baseline and 6 months
|
Sleep apnea risk
|
Baseline and 6 months
|
Prospective falls via Monthly Calendars
Time Frame: Baseline and 3 months and 6 months and monthly
|
Accidental falls
|
Baseline and 3 months and 6 months and monthly
|
Social support as measured by Social Provision Scale
Time Frame: Baseline and 6 months
|
Social support
|
Baseline and 6 months
|
Mindfulness as measured by the Mindfulness Attention Awareness Scale
Time Frame: Baseline and 6 months
|
Mindfulness
|
Baseline and 6 months
|
Memory as measured by the Everyday Memory Questionnaire
Time Frame: Baseline and 6 months
|
Memory
|
Baseline and 6 months
|
Sleep as measured by the Pittsburgh Sleep Quality Index
Time Frame: Baseline, 6 months, 12 months, and 18 months
|
Sleep
|
Baseline, 6 months, 12 months, and 18 months
|
Functional ability as measured by the Lawson IADL
Time Frame: Baseline and 6 months
|
Instrumental activities of daily living
|
Baseline and 6 months
|
Comorbidities as measured by the Function Comorbidity Index
Time Frame: Baseline, 6 months, 12 months, and 18 months
|
Chronic conditions
|
Baseline, 6 months, 12 months, and 18 months
|
Mood as measured by the State and Trait Anxiety Inventory
Time Frame: Baseline and 6 months and 18 months
|
Mood
|
Baseline and 6 months and 18 months
|
Social network as measured by Lubben Social Network Scale
Time Frame: Baseline and 6 months
|
Social network
|
Baseline and 6 months
|
Physical activity as measured by the CHAMP Questionnaire
Time Frame: Baseline and 3 months and 6 months and monthly
|
Physical Activity Level
|
Baseline and 3 months and 6 months and monthly
|
ADAS-Cog Plus
Time Frame: 18 months
|
Cognitive function
|
18 months
|
Verbal memory and learning using the Rey Auditory Verbal Learning Test
Time Frame: Baseline, 6 months, and 18 months
|
Verbal memory and learning
|
Baseline, 6 months, and 18 months
|
Verbal fluency (categorial of animals and semantic using F,A,S)
Time Frame: Baseline, 6 months, and 18 months
|
Verbal functioning tests requiring retrieval
|
Baseline, 6 months, and 18 months
|
Cytokines - proteins involved in immune response, as measured by blood
Time Frame: Baseline and 6 months
|
Cytokines
|
Baseline and 6 months
|
Dual-task gait using Gaitrite
Time Frame: Baseline and 6 months
|
Dual-task walking
|
Baseline and 6 months
|
Health resource utilization (e.g., access health system services/resources)
Time Frame: Baseline, 3 months, and 6 months
|
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
Time Frame: Baseline and 6 months
|
Physical activity levels
|
Baseline and 6 months
|
Sedentary behaviour (i.e., less than = or less than1.5 mets of activity) measured by Motion Watch actigraphy
Time Frame: Baseline and 6 months
|
Sedentary behaviour
|
Baseline and 6 months
|
Quality of life measured by EQ-5D-5L
Time Frame: Baseline, 3 months, 6 months, and 18 months
|
Quality of life
|
Baseline, 3 months, 6 months, and 18 months
|
Wellbeing measured by ICE-CAP
Time Frame: Baseline, 3 months, 6 months, and 18 months
|
Wellbeing
|
Baseline, 3 months, 6 months, and 18 months
|
Cortisol levels through saliva samples (subset)
Time Frame: 5 times from baseline to 6 months
|
Cortisol levels
|
5 times from baseline to 6 months
|
Lower body strength as measured by the 30 sec sit-to-stand (subset)
Time Frame: Baseline and 6 months and 18 months
|
Lower body strength
|
Baseline and 6 months and 18 months
|
Telemere length
Time Frame: Baseline and 6 months
|
Marker of aging
|
Baseline and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lara Boyd, PhD, University of British Columbia
- Principal Investigator: Liisa Galea, PhD, University of British Columbia
- Principal Investigator: Alexander MacKay, PhD, University of British Columbia
- Principal Investigator: Claudia Jacova, PhD, Pacific University
- Principal Investigator: Arthur Kramer, PhD, Northeastern University
- Principal Investigator: Joel Singer, PhD, University of British Columbia
- Principal Investigator: Lindsay Nagamatsu, PhD, Western University
- 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: Charlie Goldsmith, PhD, Simon Fraser University
- Principal Investigator: Ging-Yuek Robin Hsiung, MD, PhD, University of British Columbia
- Principal Investigator: Michelle Voss, PhD, University of Iowa
- Principal Investigator: Cindy Barha, PhD, University of British Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H15-02181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
-
Jennifer BramenNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Meir Medical CenterTerminatedMild Cognitive Impairment (MCI)Israel
Clinical Trials on Aerobic Training
-
Riphah International UniversityRecruiting
-
University of BarcelonaCompleted
-
General Hospital Murska SobotaUniversity of Primorska; University of LjubljanaUnknownCoronary Artery Disease | Heart Failure With Reduced Ejection FractionSlovenia
-
Hadassah Medical OrganizationCompletedThe Influence of Different Training Regimens on Electrical Stability Following Myocardial InfarctionIschemic Heart Disease | Congestive Heart FailureIsrael
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompletedMyocardial InfarctionPakistan
-
Clare MaguireRehab Basel; Bildungszetrum Gesundheit Basel-StadtCompleted
-
University of GiessenHannover Medical SchoolUnknownType 2 DiabetesGermany
-
Cardenal Herrera UniversityNot yet recruiting
-
UNC Lineberger Comprehensive Cancer CenterCompletedStem Cell Transplantation, HematopoieticUnited States