NCT05036304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 19, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

September 1, 2021

Last Update Submit

January 25, 2024

Conditions

Keywords

green spacecognitive functionaerobic exercise

Outcome Measures

Primary Outcomes (2)

  • Change in List Sorting Performance

    This is a measure of working memory

    Baseline to 12 weeks

  • Change in Digits Span Forwards and Backwards

    This is a measure of working memory.

    Baseline to 12 weeks

Secondary Outcomes (18)

  • Change in NIH Toolbox Cognitive Battery Performance

    Baseline to 12 weeks

  • Change in Digit Symbol Substitute Test

    Baseline to 12 weeks

  • Change in the Short Physical Performance Battery

    Baseline to 12 weeks

  • Change in Timed Up and Go Test

    Baseline to 12 weeks

  • Change in State-Trait Anxiety Inventory

    Baseline to 12 weeks and 6 months

  • +13 more secondary outcomes

Study Arms (2)

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.

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).

Other: Aerobic Exercise Outdoors

Interventions

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 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)

Aerobic Exercise Outdoors

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z1M9, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Teresa Liu-Ambrose, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Matthew Noseworthy, BSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Assessor will be blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 5, 2021

Study Start

January 19, 2022

Primary Completion

July 10, 2023

Study Completion

November 27, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Locations