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Supporting Aging Through Green Exercise (SAGE) (SAGE)

Primary Purpose

Mild Cognitive Impairment, Aging

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Aerobic Exercise Indoors
Aerobic Exercise Outdoors
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring green space, cognitive function, aerobic exercise

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. achieve a score ≥18/30 and ≤24/30 on the Montreal Cognitive Assessment
  2. have subjective cognitive impairment based on interview
  3. 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
  4. no diagnosis of dementia
  5. aged 65 to 80 years old
  6. live independently in their own home
  7. live in the Greater Vancouver area
  8. read, write, and speak English with acceptable visual and auditory acuity
  9. are cleared to start a supervised exercise programme based on the Physical Activity Readiness Questionnaire for Everyone
  10. able to walk independently
  11. able to provide informed consent

Exclusion Criteria:

  1. participating in regular moderate to vigorous intensity aerobic exercise in the last 3 months
  2. planning to enroll in a concurrent exercise or drug trial targeting cognitive function
  3. diagnosed with a neurological, cerebrovascular, or psychiatric disease, or other chronic medical condition requiring intensive treatment and monitoring
  4. have major impairments in eyesight, hearing or motor movements
  5. have clinically significant neuropathy or musculoskeletal or joint disease
  6. have a recent traumatic brain injury, including concussions
  7. are currently using prescribed cognitive intervention or electromagnetic stimulation
  8. 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

Sites / Locations

  • University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aerobic Exercise Indoors

Aerobic Exercise Outdoors

Arm Description

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).

Outcomes

Primary Outcome Measures

Change in List Sorting Performance
This is a measure of working memory.
Change in Digits Span Forwards and Backwards
This is a measure of working memory.

Secondary Outcome Measures

Change in NIH Toolbox Cognitive Battery Performance
Measures different cognitive domains
Change in Digit Symbol Substitute Test
A measure of processing speed and executive functions.
Change in the Short Physical Performance Battery
A measure of balance and mobility
Change in Timed Up and Go Test
A measure of general mobility
Change in State-Trait Anxiety Inventory
A measure of anxiety
Change in Centre for Epidemiological Studies Depression Scale
A measure of depressive symptoms
Change in Blood Pressure
Systolic and diastolic blood pressure
Change in sensor measured sleep
Using MotionWatch 8 to measure sleep quality
Change in sensor measured physical activity
Using MotionWatch 8 to measure levels and amount of physical activity
Change in Physical Activity Scale for the Elderly
A self-report measure of physical activity, higher scores indicate higher activity
Change in Pittsburgh Sleep Quality Index
A self-report measure of sleep quality, higher scores indicate poorer sleep quality
Change in ICEpop CAPability measure for Older people (ICECAP-O)
A measure of quality of life, higher values indicate better quality of life
5-level EuroQoL 5-dimension (EQ-5D-5L) questionnaire
A measure of quality of life, higher values indicate better quality of life

Full Information

First Posted
September 1, 2021
Last Updated
November 5, 2022
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05036304
Brief Title
Supporting Aging Through Green Exercise (SAGE)
Acronym
SAGE
Official Title
Supporting Aging Through Green Exercise (SAGE): Comparing the Cognitive Effects of Outdoor Versus Indoor Exercise Among Older Adults With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Aging
Keywords
green space, cognitive function, aerobic exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Assessor will be blinded.
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise Indoors
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aerobic Exercise Outdoors
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Indoors
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise Outdoors
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in List Sorting Performance
Description
This is a measure of working memory.
Time Frame
Baseline to 12 weeks
Title
Change in Digits Span Forwards and Backwards
Description
This is a measure of working memory.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in NIH Toolbox Cognitive Battery Performance
Description
Measures different cognitive domains
Time Frame
Baseline to 12 weeks
Title
Change in Digit Symbol Substitute Test
Description
A measure of processing speed and executive functions.
Time Frame
Baseline to 12 weeks
Title
Change in the Short Physical Performance Battery
Description
A measure of balance and mobility
Time Frame
Baseline to 12 weeks
Title
Change in Timed Up and Go Test
Description
A measure of general mobility
Time Frame
Baseline to 12 weeks
Title
Change in State-Trait Anxiety Inventory
Description
A measure of anxiety
Time Frame
Baseline to 12 weeks and 6 months
Title
Change in Centre for Epidemiological Studies Depression Scale
Description
A measure of depressive symptoms
Time Frame
Baseline to 12 weeks and 6 months
Title
Change in Blood Pressure
Description
Systolic and diastolic blood pressure
Time Frame
Baseline to 12 weeks
Title
Change in sensor measured sleep
Description
Using MotionWatch 8 to measure sleep quality
Time Frame
Baseline to 12 weeks
Title
Change in sensor measured physical activity
Description
Using MotionWatch 8 to measure levels and amount of physical activity
Time Frame
Baseline to 12 weeks
Title
Change in Physical Activity Scale for the Elderly
Description
A self-report measure of physical activity, higher scores indicate higher activity
Time Frame
Baseline to 12 weeks and 6 months
Title
Change in Pittsburgh Sleep Quality Index
Description
A self-report measure of sleep quality, higher scores indicate poorer sleep quality
Time Frame
Baseline to 12 weeks and 6 months
Title
Change in ICEpop CAPability measure for Older people (ICECAP-O)
Description
A measure of quality of life, higher values indicate better quality of life
Time Frame
Baseline to 12 weeks and 6 months
Title
5-level EuroQoL 5-dimension (EQ-5D-5L) questionnaire
Description
A measure of quality of life, higher values indicate better quality of life
Time Frame
Baseline to 12 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Liu Ambrose, PhD
Phone
16046178047
Email
teresa.ambrose@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Grant, BSc
Phone
16048754111
Ext
69223
Email
cogmob.research@hiphealth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Liu-Ambrose, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Noseworthy, BSc
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Supporting Aging Through Green Exercise (SAGE)

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