- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05036304
Supporting Aging Through Green Exercise (SAGE) (SAGE)
Supporting Aging Through Green Exercise (SAGE): Comparing the Cognitive Effects of Outdoor Versus Indoor Exercise Among Older Adults With Mild Cognitive Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Design: A 12-week, single-blinded, trial with two experimental arms. Participants will be randomized (1:1) to either outdoor walking (OP) or indoor walking or cycling (IP). Measurement will occur in person at baseline and at trial completion. Additionally, follow-up measurement of questionnaire-based outcomes will occur via email or phone at 3 months following trial completion. Outcome assessors will be trained by the research team and blinded to group allocation of the participants.
Participants: 68 community-dwelling adults aged 65-80 years old with probable MCI and in sufficient health to participate in aerobic exercise of moderate intensity
Interventional Arms: All participants will receive three group-based training sessions per week for 12 weeks, under the supervision of instructors with a relevant background and first aid certification. Each session will consist of 10 min of warm-up, 40 min of aerobic exercise, and 10 min of cool-down. For both OP and IP, aerobic exercise will be progressive and of moderate intensity. During training, each participant will wear a heart rate monitor and will be asked to work initially at approximately 45% of their heart rate reserve (HRR) and gradually progress to reach the target of 70% of HRR over the 12-week study period. Participants will also subjectively monitor workout intensity using the 20-point Borg's Rating of Perceived Exertion. OP participants will walk or jog a pre-determined route in trails of an urban forest (Pacific Spirit Park). IP participants will walk or jog on treadmills in the Exercise Prescription Suite of the Centre for Hip Health and Mobility (CHHM). Both OP and IP training groups will have a participant to instructor ratio of 3:1. To promote adherence to the exercise program, sessions will be offered at times that are convenient for each individual participant. Protocols will be adjusted as necessary to align with COVID-19 guidelines.
Measurement of descriptors and outcomes: Standardized protocols will be developed and study personnel will be trained. Assessors will be blinded to treatment allocation. We will measure descriptors and outcomes at baseline and at trial completion. Each measurement session will be 2 hours in duration. For these measurements, participants will complete a session of behavioural and clinical testing at the VCH Research Pavilion and the CHHM. To account for time-of-day effects, each participant's session start time will be the same at both timepoints, and the order of the assessments will be the same for all participants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z1M9
- University of British Columbia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- achieve a score ≥18/30 and ≤24/30 on the Montreal Cognitive Assessment
- have subjective cognitive impairment based on interview
- have no significant impairment in daily function, as determined by a score ≥6/8 on the Lawton and Brody Instrumental Activities of Daily Living Scale
- no diagnosis of dementia
- aged 65 to 80 years old
- live independently in their own home
- live in the Greater Vancouver area
- read, write, and speak English with acceptable visual and auditory acuity
- are cleared to start a supervised exercise programme based on the Physical Activity Readiness Questionnaire for Everyone
- able to walk independently
- able to provide informed consent
Exclusion Criteria:
- participating in regular moderate to vigorous intensity aerobic exercise in the last 3 months
- planning to enroll in a concurrent exercise or drug trial targeting cognitive function
- diagnosed with a neurological, cerebrovascular, or psychiatric disease, or other chronic medical condition requiring intensive treatment and monitoring
- have major impairments in eyesight, hearing or motor movements
- have clinically significant neuropathy or musculoskeletal or joint disease
- have a recent traumatic brain injury, including concussions
- are currently using prescribed cognitive intervention or electromagnetic stimulation
- at the time of recruit, indicate they recently (within the last 2 months) or will start taking drugs that significantly alter cognition, movement, or affect, such as cholinesterase inhibitors, anticholinergics, hormone replacement therapy, or antidepressants
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aerobic Exercise Indoors
Each session will consist of 10 min of warm-up, 40 min of aerobic exercise, and 10 min of cool-down.
Aerobic exercise will be progressive and of moderate intensity.
During training, each participant will wear a heart rate monitor and will be asked to work initially at approximately 45% of his/her target heart rate (i.e., heart rate reserve (HRR)) and gradually progress to reach the target of 70% of HRR over the 12-week study period.
Participants will also subjectively monitor workout intensity using the 20-point Borg's Rating of Perceived Exertion.
Participants will walk or jog on treadmills or cycle on stationary bikes in the Exercise Prescription Suite of the Centre for Hip Health and Mobility.
|
Each session will consist of 10 min of warm-up, 40 min of aerobic exercise, and 10 min of cool-down.
Aerobic exercise will be progressive and of moderate intensity.
During training, each participant will wear a heart rate monitor and will be asked to work initially at approximately 45% of his/her target heart rate (i.e., heart rate reserve (HRR)) and gradually progress to reach the target of 70% of HRR over the 12-week study period.
Participants will also subjectively monitor workout intensity using the 20-point Borg's Rating of Perceived Exertion.
Participants will walk or jog on treadmills or cycle on stationary bikes in the Exercise Prescription Suite of the Centre for Hip Health and Mobility.
|
Experimental: Aerobic Exercise Outdoors
Each session will consist of 10 min of warm-up, 40 min of aerobic exercise, and 10 min of cool-down.
Aerobic exercise will be progressive and of moderate intensity.
During training, each participant will wear a heart rate monitor and will be asked to work initially at approximately 45% of his/her target heart rate (i.e., heart rate reserve (HRR)) and gradually progress to reach the target of 70% of HRR over the 12-week study period.
Participants will also subjectively monitor workout intensity using the 20-point Borg's Rating of Perceived Exertion.
participants will walk or jog pre-determined routes in trails of an urban forest (Pacific Spirit Park).
|
Each session will consist of 10 min of warm-up, 40 min of aerobic exercise, and 10 min of cool-down.
Aerobic exercise will be progressive and of moderate intensity.
During training, each participant will wear a heart rate monitor and will be asked to work initially at approximately 45% of his/her target heart rate (i.e., heart rate reserve (HRR)) and gradually progress to reach the target of 70% of HRR over the 12-week study period.
Participants will also subjectively monitor workout intensity using the 20-point Borg's Rating of Perceived Exertion.
Participants will walk or jog pre-determined routes in trails of an urban forest (Pacific Spirit Park)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Digits Span Forwards and Backwards
Time Frame: Baseline to 12 weeks
|
This is a measure of working memory.
|
Baseline to 12 weeks
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Change in List Sorting Performance
Time Frame: Baseline to 12 weeks
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This is a measure of working memory
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Baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Digit Symbol Substitute Test
Time Frame: Baseline to 12 weeks
|
A measure of processing speed and executive functions.
|
Baseline to 12 weeks
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Change in the Short Physical Performance Battery
Time Frame: Baseline to 12 weeks
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A measure of balance and mobility
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Baseline to 12 weeks
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Change in Timed Up and Go Test
Time Frame: Baseline to 12 weeks
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A measure of general mobility
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Baseline to 12 weeks
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Change in State-Trait Anxiety Inventory
Time Frame: Baseline to 12 weeks and 6 months
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A measure of anxiety
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Baseline to 12 weeks and 6 months
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Change in Centre for Epidemiological Studies Depression Scale
Time Frame: Baseline to 12 weeks and 6 months
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A measure of depressive symptoms
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Baseline to 12 weeks and 6 months
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Change in Blood Pressure
Time Frame: Baseline to 12 weeks
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Systolic and diastolic blood pressure
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Baseline to 12 weeks
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Change in sensor measured sleep
Time Frame: Baseline to 12 weeks
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Using MotionWatch 8 to measure sleep quality
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Baseline to 12 weeks
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Change in sensor measured physical activity
Time Frame: Baseline to 12 weeks
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Using MotionWatch 8 to measure levels and amount of physical activity
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Baseline to 12 weeks
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Change in Physical Activity Scale for the Elderly
Time Frame: Baseline to 12 weeks and 6 months
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A self-report measure of physical activity, higher scores indicate higher activity
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Baseline to 12 weeks and 6 months
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Change in Pittsburgh Sleep Quality Index
Time Frame: Baseline to 12 weeks and 6 months
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A self-report measure of sleep quality, higher scores indicate poorer sleep quality
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Baseline to 12 weeks and 6 months
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Change in ICEpop CAPability measure for Older people (ICECAP-O)
Time Frame: Baseline to 12 weeks and 6 months
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A measure of quality of life, higher values indicate better quality of life
|
Baseline to 12 weeks and 6 months
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5-level EuroQoL 5-dimension (EQ-5D-5L) questionnaire
Time Frame: Baseline to 12 weeks and 6 months
|
A measure of quality of life, higher values indicate better quality of life
|
Baseline to 12 weeks and 6 months
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Change in NIH Toolbox Cognitive Battery Performance
Time Frame: Baseline to 12 weeks
|
Measures different cognitive domains, with a focus on executive functions
|
Baseline to 12 weeks
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Change in gait speed, derived from Short Physical Performance Battery
Time Frame: Baseline to 12 weeks.
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A measure of walking speed.
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Baseline to 12 weeks.
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Changes in hemodynamics of the brain as measured by fNIRS during the N-Back Task
Time Frame: Baseline to 12 weeks.
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A measure of brain function.
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Baseline to 12 weeks.
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Changes in Feeling Scale
Time Frame: Baseline to 12 weeks.
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Measure of affective valence
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Baseline to 12 weeks.
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Changes in Exercise Enjoyment Scale
Time Frame: Baseline to 12 weeks.
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An affective measure
|
Baseline to 12 weeks.
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Changes in Felt Arousal Scale
Time Frame: Baseline to 12 weeks
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Measure of affective activation
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Baseline to 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Teresa Liu-Ambrose, PhD, University of British Columbia
- Principal Investigator: Matthew Noseworthy, BSc, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H21-00406
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.
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