An interventional study of Aerobic Exercise Indoors and Aerobic Exercise Outdoors in Mild Cognitive Impairment and Aging, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention
Aerobic exercise is an evidence-based approach to mitigate cognitive decline in older adults with mild cognitive impairment (MCI). Emerging evidence suggests that the cognitive benefits of exercise may be enhanced when performed in outdoor, natural settings, as compared to indoor or built settings. Thus, the investigators aim to compare the effects of outdoor versus indoor walking programs on cognitive function among older adults with MCI. Secondary outcomes are motor function, emotional well-being, health-related behaviours, and quality of life. Participants will be randomly assigned to a 12--week, 3x/week program of either outdoor walking on forest trails or indoor walking on a treadmill. A 3-month followup will also be completed after trial completion.
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.
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This study's enrollment of 72 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
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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.
Other: 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 pre-determined routes in trails of an urban forest (Pacific Spirit Park).
Other: 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 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 pre-determined routes in trails of an urban forest (Pacific Spirit Park)
Change in List Sorting Performance
This is a measure of working memory
Time frame: Baseline to 12 weeks
Change in Digits Span Forwards and Backwards
This is a measure of working memory.
Time frame: Baseline to 12 weeks
Change in NIH Toolbox Cognitive Battery Performance
Measures different cognitive domains, with a focus on executive functions
Time frame: Baseline to 12 weeks
Change in Digit Symbol Substitute Test
A measure of processing speed and executive functions.
Time frame: Baseline to 12 weeks
Change in the Short Physical Performance Battery
A measure of balance and mobility
Time frame: Baseline to 12 weeks
Change in Timed Up and Go Test
A measure of general mobility
Time frame: Baseline to 12 weeks
Change in State-Trait Anxiety Inventory
A measure of anxiety
Time frame: Baseline to 12 weeks and 6 months
Change in Centre for Epidemiological Studies Depression Scale
A measure of depressive symptoms
Time frame: Baseline to 12 weeks and 6 months
Change in Blood Pressure
Systolic and diastolic blood pressure
Time frame: Baseline to 12 weeks
Change in sensor measured sleep
Using MotionWatch 8 to measure sleep quality
Time frame: Baseline to 12 weeks
Change in sensor measured physical activity
Using MotionWatch 8 to measure levels and amount of physical activity
Time frame: Baseline to 12 weeks
Change in Physical Activity Scale for the Elderly
A self-report measure of physical activity, higher scores indicate higher activity
Time frame: Baseline to 12 weeks and 6 months
Change in Pittsburgh Sleep Quality Index
A self-report measure of sleep quality, higher scores indicate poorer sleep quality
Time frame: Baseline to 12 weeks and 6 months
Change in ICEpop CAPability measure for Older people (ICECAP-O)
A measure of quality of life, higher values indicate better quality of life
Time frame: Baseline to 12 weeks and 6 months
5-level EuroQoL 5-dimension (EQ-5D-5L) questionnaire
A measure of quality of life, higher values indicate better quality of life
Time frame: Baseline to 12 weeks and 6 months
Change in gait speed, derived from Short Physical Performance Battery
A measure of walking speed.
Time frame: Baseline to 12 weeks.
Changes in hemodynamics of the brain as measured by fNIRS during the N-Back Task
A measure of brain function.
Time frame: Baseline to 12 weeks.
Changes in Feeling Scale
Measure of affective valence
Time frame: Baseline to 12 weeks.
Changes in Exercise Enjoyment Scale
An affective measure
Time frame: Baseline to 12 weeks.
Changes in Felt Arousal Scale
Measure of affective activation
Time frame: Baseline to 12 weeks
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of British Columbia