Mild Cognitive ImpairmentSAGENCT05036304
Supporting Aging Through Green Exercise (SAGE)
A study testing Aerobic Exercise Indoors and Aerobic Exercise Outdoors in people with Mild Cognitive Impairment and Aging, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Aging
- What is being tested?
- Aerobic Exercise Indoors and Aerobic Exercise Outdoors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jan 2022to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z1M9
About this study
Official title: Supporting Aging Through Green Exercise (SAGE): Comparing the Cognitive Effects of Outdoor Versus Indoor Exercise Among Older Adults With Mild Cognitive Impairment
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Aging
- Being tested
- Aerobic Exercise Indoors, Aerobic Exercise Outdoors
- Keywords
- green space, cognitive function, aerobic exercise
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise IndoorsOther
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.
Aerobic Exercise OutdoorsOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Indoors | Active comparator | 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. Receives: Other: Aerobic Exercise Indoors |
| Aerobic Exercise Outdoors | Experimental | 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). Receives: Other: Aerobic Exercise Outdoors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in List Sorting Performance
This is a measure of working memory
Measured: Baseline to 12 weeks
Change in Digits Span Forwards and Backwards
This is a measure of working memory.
Measured: Baseline to 12 weeks
Secondary outcomes (18)
Change in NIH Toolbox Cognitive Battery Performance
Measures different cognitive domains, with a focus on executive functions
Measured: Baseline to 12 weeks
Change in Digit Symbol Substitute Test
A measure of processing speed and executive functions.
Measured: Baseline to 12 weeks
Change in the Short Physical Performance Battery
A measure of balance and mobility
Measured: Baseline to 12 weeks
Change in Timed Up and Go Test
A measure of general mobility
Measured: Baseline to 12 weeks
Change in State-Trait Anxiety Inventory
A measure of anxiety
Measured: Baseline to 12 weeks and 6 months
Change in Centre for Epidemiological Studies Depression Scale
A measure of depressive symptoms
Measured: Baseline to 12 weeks and 6 months
Change in Blood Pressure
Systolic and diastolic blood pressure
Measured: Baseline to 12 weeks
Change in sensor measured sleep
Using MotionWatch 8 to measure sleep quality
Measured: Baseline to 12 weeks
Change in sensor measured physical activity
Using MotionWatch 8 to measure levels and amount of physical activity
Measured: Baseline to 12 weeks
Change in Physical Activity Scale for the Elderly
A self-report measure of physical activity, higher scores indicate higher activity
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 12 weeks and 6 months
Change in gait speed, derived from Short Physical Performance Battery
A measure of walking speed.
Measured: Baseline to 12 weeks.
Changes in hemodynamics of the brain as measured by fNIRS during the N-Back Task
A measure of brain function.
Measured: Baseline to 12 weeks.
Changes in Feeling Scale
Measure of affective valence
Measured: Baseline to 12 weeks.
Changes in Exercise Enjoyment Scale
An affective measure
Measured: Baseline to 12 weeks.
Changes in Felt Arousal Scale
Measure of affective activation
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start19 Jan 2022
- Primary completion10 Jul 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Liu-Ambrose, University of British Columbia
- Investigators
- Teresa Liu-Ambrose, PhD, Principal investigator, University of British ColumbiaMatthew Noseworthy, BSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036304
- Sponsor's protocol ID
- H21-00406
- Acronym
- SAGE
- Status last verified
- Jan 2024
- First submitted
- 1 Sep 2021
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Aging Through Green Exercise (SAGE): Comparing the Cognitive Effects of Outdoor Versus Indoor Exercise Among Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05036304
- Acronym / sponsor ID
- SAGE / H21-00406
- Conditions
- Mild Cognitive Impairment, Aging
- Keywords
- green space, cognitive function, aerobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Indoors | Active comparator | Other: Aerobic Exercise IndoorsEach 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. |
| Aerobic Exercise Outdoors | Experimental | Other: Aerobic Exercise OutdoorsEach 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). |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise IndoorsEach 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 |
| Aerobic Exercise OutdoorsEach 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 |
Primary outcome
Change in List Sorting Performance
Time frame: Baseline to 12 weeks
This is a measure of working memory
Change in Digits Span Forwards and Backwards
Time frame: Baseline to 12 weeks
This is a measure of working memory.
18 secondary outcomes
Change in NIH Toolbox Cognitive Battery Performance
Time frame: Baseline to 12 weeks
Change in Digit Symbol Substitute Test
Time frame: Baseline to 12 weeks
Change in the Short Physical Performance Battery
Time frame: Baseline to 12 weeks
Change in Timed Up and Go Test
Time frame: Baseline to 12 weeks
Change in State-Trait Anxiety Inventory
Time frame: Baseline to 12 weeks and 6 months
Change in Centre for Epidemiological Studies Depression Scale
Time frame: Baseline to 12 weeks and 6 months
Change in Blood Pressure
Time frame: Baseline to 12 weeks
Change in sensor measured sleep
Time frame: Baseline to 12 weeks
Change in sensor measured physical activity
Time frame: Baseline to 12 weeks
Change in Physical Activity Scale for the Elderly
Time frame: Baseline to 12 weeks and 6 months
Change in Pittsburgh Sleep Quality Index
Time frame: Baseline to 12 weeks and 6 months
Change in ICEpop CAPability measure for Older people (ICECAP-O)
Time frame: Baseline to 12 weeks and 6 months
5-level EuroQoL 5-dimension (EQ-5D-5L) questionnaire
Time frame: Baseline to 12 weeks and 6 months
Change in gait speed, derived from Short Physical Performance Battery
Time frame: Baseline to 12 weeks.
Changes in hemodynamics of the brain as measured by fNIRS during the N-Back Task
Time frame: Baseline to 12 weeks.
Changes in Feeling Scale
Time frame: Baseline to 12 weeks.
Changes in Exercise Enjoyment Scale
Time frame: Baseline to 12 weeks.
Changes in Felt Arousal Scale
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Liu-Ambrose, PhD principal investigator
University of British Columbia
Matthew Noseworthy, BSc principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Indoors and Aerobic Exercise Outdoors in people with Mild Cognitive Impairment and Aging, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in List Sorting Performance (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.