AzTrials
AzTrials

Mild Cognitive ImpairmentNCT02737878

Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription

A study testing Aerobic Training, Resistance Training and Balance and Tone Training in people with Mild Cognitive Impairment, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Dementia is one of the most pressing health care issues of the 21st century. Evidence suggests that exercise enhances cognitive function in healthy older adults. Most research has focused on aerobic training (AT). Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Aerobic Training, Resistance Training and Balance and Tone Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
1 siteCanada
Study dates
13 Nov 2017to 26 Aug 2025
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
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Community-dwelling in Metro Vancouver
  • Have subjective memory complaints, defined as the self-reported feeling of memory worsening with an onset within the last 5 years, as determined by interview and corroborated by an informant
  • Have a baseline Montreal Cognitive Assessment (MoCA) score < 26/30
  • Mini-Mental State Examination (MMSE) score = or > 22 at screening
  • Read, write, and speak English
  • Not expected to start or are stable on a fixed dose of anti-dementia medications (e.g., donepezil, galantamine, etc.) during the 6-month intervention period
Show all 10Show fewer
  • Able to walk independently
  • Must be in sufficient health to participate in the exercise programs
  • Able to comply with scheduled visits, treatment plan, and other trial procedures
  • Provide a personally signed and dated informed consent document indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. In addition, an assent form will be provided at baseline and again at regular intervals

Who cannot join

  • Engaged in moderate (e.g., brisk walking) physical activity > 1 time per week, or > 60 minutes per week, in the 3 months prior to study entry
  • Diagnosed with dementia of any type
  • Clinically suspected to have neurodegenerative disease as the cause of mild cognitive impairment (MCI) that is not Alzheimer's Disease (AD), vascular cognitive impairment (VCI), or both (e.g., multiple sclerosis, Parkinson's disease, Huntington's disease, frontotemporal dementia)
  • At high risk for cardiac complications during exercise or unable to self-regulate activity or to understand recommended activity level; 5) have clinically important peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician
  • Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (i.e., typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid)
  • On any hormone therapy (estrogen, progesterone, or testosterone) in the last 24 months
  • Planning to participate, or already enrolled in, a concurrent clinical drug or exercise trial

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of British Columbia

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Official title: Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription: Understanding Training Type and Exploring Mechanisms

Dementia is one of the most pressing health care issues of the 21st century. Evidence suggests that exercise enhances cognitive function in healthy older adults. Most research has focused on aerobic training (AT). Therefore, investigators aim to assess the individual effects of AT and resistance training (RT), as well as the interaction effect of combining the two types of exercise training, on cognitive function in older adults with mild cognitive impairment.

Read the detailed description

Investigators will conduct a 6-month assessor-blinded randomized-controlled trial of 216 community-dwelling adults with mild cognitive impairment. Individuals will be randomized to one of four experimental groups, all which receive 6 months of exercise classes four times per week: 1) combined aerobic training and resistance training; 2) aerobic training; 3) resistance training; or 4) balance and toning exercise. There will be two measurement sessions: baseline and 6 months (end of intervention period). A 12-month followup (i.e., 18 months from baseline) measurement will also be done.

Being tested
Aerobic Training, Resistance Training, Balance and Tone Training
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 TrainingBehavioural

    Six months of twice-weekly aerobic training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).

    To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of wearables to monitor heart rate. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

  • Resistance TrainingBehavioural

    Six months of twice-weekly resistance training program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).

    To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of a set of resistance bands of various weights. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

  • Balance and Tone TrainingBehavioural

    Six months of twice-weekly stretching and relaxation program that includes stretching exercises, range of motion exercises, basic core-strength/kegal exercises, static balance exrecises, functional strength exercises (e.g., sit to stand), and relaxation techniques. Each session will be 60 minutes.

    To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of small equipment (e.g., pilate ball). Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

  • Balance and Tone TrainingBehavioural

    Six months of twice-weekly stretching and relaxation program that includes stretching exercises, range of motion exercises, basic core-strength/kegal exercises, static balance exrecises, functional strength exercises (e.g., sit to stand), and relaxation techniques. Each session will be 60 minutes.

    To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of small equipment (e.g., pilate ball). Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and adherence.

Study groups in NCT02737878
Study groupRoleWhat they receive
Aerobic Training and Resistance Training (AT&RT)ExperimentalThe AT\&RT program will be a four-times-per week program. Twice a week will be aerobic training (AT) with a series of standardized AT exercise stations. Participants rotate through each station within the 40-min training duration with approx. 1-min rest between stations. Participants will exercise initially at approximately 50% of their age specific target heart rate reserve and gradually progress to reach the target of 80% of HRR. The other two days a week will be resistance training (RT) in which a pressurized air system and free weights will be used to provide the training stimulus. The initial intensity of the training stimulus will be set to a weight where participants can complete 2 sets of 10-15 repetitions. Training intensity will then progress on a cyclic basis from 45 to 85% of predicted 1 repetition maximum (1RM) as determined at week 6 using an 8-repetition maximum (8RM) test. Every 4 weeks, the 8RM test is repeated and the cycle repeats.
Receives: Behavioral: Aerobic Training; Behavioral: Resistance Training
Aerobic Training (AT)ExperimentalThe AT program will be a four-times-per week program. Twice a week will be AT with a series of standardized AT exercise stations (e.g., treadmills, stationary cycles, aerobic steppers, agility ladders). Participants rotate through each station within the 40-min training duration with approx. 1-min rest between stations. Participants will exercise initially at approximately 50% of their age specific target heart rate reserve and gradually progress to reach the target of 80% of HRR. The other two days per week will be a balance and tone (CON) program consisting of stretching exercises, range of motion exercises, basic core-strength/kegal exercises, static balance exrecises, functional strength exercises (e.g., sit to stand), and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.
Receives: Behavioral: Aerobic Training; Behavioral: Balance and Tone Training
Resistance Training (RT)ExperimentalThe RT program will be a four-times-per week program. Twice a week will be RT in which a pressurized air system and free weights will be used to provide the training stimulus. The initial intensity of the training stimulus will be set to a weight where participants can complete 2 sets of 10-15 repetitions. Training intensity will then progress on a cyclic basis from 45 to 85% of predicted 1 RM as determined at week 6 using an 8RM test. Every 4 weeks, the 8RM test is repeated and the cycle repeats.The other two days per week will be a CON program consisting of stretching exercises, range of motion exercises, basic core-strength/kegal exercises, static balance exrecises, functional strength exercises (e.g., sit to stand), and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.
Receives: Behavioral: Resistance Training; Behavioral: Balance and Tone Training
Balance and Tone Program (CON)Active comparatorThe CON program will be a four-times-per week program. The CON group will consiste of stretching exercises, range of motion exercises, basic core-strength/kegal exercises, static balance exrecises, functional strength exercises (e.g., sit to stand), and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the CON exercises.
Receives: Behavioral: Balance and Tone Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus)

    Cognition

    Measured: Baseline to 6 months

Secondary outcomes (55)
  1. Executive functions as measured by standard neuropsychological and computerized tests

    Executive functions

    Measured: Baseline and 6 months and 18 months

  2. Intraindividual variability (IIV) in executive functions as measured by the NIH ToolBox Cognitive Battery

    IIV of executive functions

    Measured: Baseline and 6 months and 18 months

  3. Cardiometabolic risk factors as measured by blood panel

    Cardiometabolic risk factors

    Measured: Baseline and 6 months

  4. Health related quality of life as measured by the EuroQol five dimensions questionnaire (EQ-5D-5L)

    Quality of life

    Measured: Baseline, 3 months, 6 months, 12 months, and 18 months

  5. Health related quality of life as measured by the ICE-CAP

    Quality of life

    Measured: Baseline, 3 months, 6 months, 12 months, and 18 months

  6. Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)

    Depressive symptoms

    Measured: Baseline and 6 months

  7. Brain function as measured by functional magnetic resonance imaging (fMRI)

    Brain function

    Measured: Baseline and 6 months

  8. Brain structure as measured by structural magnetic resonance imaging

    Brain structure

    Measured: Baseline and 6 months

  9. White matter lesion volume as measured by magnetic resonance imaging

    White matter lesion

    Measured: Baseline and 6 months

  10. Diffusion tensor imaging as measured by magnetic resonance imaging

    White matter integrity

    Measured: Baseline and 6 months

  11. Memory as measured by standard neuropsychological and computerized tests

    Memory

    Measured: Baseline and 6 months and 18 months

  12. Intraindividual variability (IIV) in memory as measured by the NIH ToolBox Cognitive Battery

    IIV of memory

    Measured: Baseline and 6 months and 18 months

  13. Visualspatial ability as measured by standard neuropsychological and computerized tests

    Visualspatial ability

    Measured: Baseline and 6 months

  14. Cardiorespiratory capacity as measured by treadmill test

    Cardiovascular fitness

    Measured: Baseline and 6 months

  15. Mobility as measured by 400-m walk

    Mobility

    Measured: Baseline and 6 months and 18 months

  16. Cardiorespiratory capacity esimated from 400-m walk

    Estimated cardiovascular fitness

    Measured: Baseline and 6 months and 18 months

  17. Cardiometabolic risk as measured by waist to hip ratio

    Cardiometabolic risk

    Measured: Baseline and 6 months and 18 months

  18. Cardiometabolic risk as measured by body mass index

    Cardiometabolic risk

    Measured: Baseline and 6 months and 18 months.

  19. Cardiometabolic risk as measured by pulse wave velocity (arterial stiffness)

    Cardiometabolic risk

    Measured: Baseline and 6 months

  20. Cortisol levels through saliva samples (subset)

    Cortisol levels

    Measured: 5 times from baseline to 6 months

  21. Lower body strength as measured by the 30 sec sit-to-stand (subset)

    Lower body strength

    Measured: Baseline and 6 months and 18 months

  22. Lower body strength as measured by Biodex

    Lower body strength

    Measured: Baseline and 6 months

  23. Upper body strength as measured by grip strength

    Upper body strength

    Measured: Baseline and 6 months

  24. Sleep quality as measured by Motion Watch actigraphy

    Sleep quality

    Measured: Baseline and 6 months

  25. Neurotrophic factors as measured by blood

    Neurotrophic factors

    Measured: Baseline and 6 months

  26. Mobility as measured by Short Physical Performance Battery

    Mobility

    Measured: Baseline and 6 months and 18 months

  27. Community mobility as measured by the Life Space Questionnaire

    Mobility

    Measured: Baseline, 3 months, 6 months, 12 months, and 18 months

  28. Body composition as measured by DXA

    Body composition (lean \& fat mass)

    Measured: Baseline and 6 months

  29. Loneliness as measured by the UCLA Loneliness Scale

    Loneliness

    Measured: Baseline and 6 months

  30. Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale - 13 items

    Cognitive function

    Measured: Baseline and 6 months and 18 months

  31. Sedentary behaviour as measure by the Sedentary Behaviour Questionnaire

    Sedentary behaviour

    Measured: Baseline, 3 months, 6 months, 12 months, and 18 months

  32. Risk of sleep apnea as measured by the STOP Bang Questionnaire

    Sleep apnea risk

    Measured: Baseline and 6 months

  33. Prospective falls via Monthly Calendars

    Accidental falls

    Measured: Baseline and 3 months and 6 months and monthly

  34. Social support as measured by Social Provision Scale

    Social support

    Measured: Baseline and 6 months

  35. Mindfulness as measured by the Mindfulness Attention Awareness Scale

    Mindfulness

    Measured: Baseline and 6 months

  36. Memory as measured by the Everyday Memory Questionnaire

    Memory

    Measured: Baseline and 6 months

  37. Sleep as measured by the Pittsburgh Sleep Quality Index

    Sleep

    Measured: Baseline, 6 months, 12 months, and 18 months

  38. Functional ability as measured by the Lawson IADL

    Instrumental activities of daily living

    Measured: Baseline and 6 months

  39. Comorbidities as measured by the Function Comorbidity Index

    Chronic conditions

    Measured: Baseline, 6 months, 12 months, and 18 months

  40. Mood as measured by the State and Trait Anxiety Inventory

    Mood

    Measured: Baseline and 6 months and 18 months

  41. Social network as measured by Lubben Social Network Scale

    Social network

    Measured: Baseline and 6 months

  42. Physical activity as measured by the CHAMP Questionnaire

    Physical Activity Level

    Measured: Baseline and 3 months and 6 months and monthly

  43. ADAS-Cog Plus

    Cognitive function

    Measured: 18 months

  44. Verbal memory and learning using the Rey Auditory Verbal Learning Test

    Verbal memory and learning

    Measured: Baseline, 6 months, and 18 months

  45. Verbal fluency (categorial of animals and semantic using F,A,S)

    Verbal functioning tests requiring retrieval

    Measured: Baseline, 6 months, and 18 months

  46. Cytokines - proteins involved in immune response, as measured by blood

    Cytokines

    Measured: Baseline and 6 months

  47. Dual-task gait using Gaitrite

    Dual-task walking

    Measured: Baseline and 6 months

  48. Health resource utilization (e.g., access health system services/resources)

    Access health system services/resources

    Measured: Baseline, 3 months, and 6 months

  49. Physical activity level (i.e., amount of light, moderate, and vigorous) measured by Motion Watch actigraphy

    Physical activity levels

    Measured: Baseline and 6 months

  50. Sedentary behaviour (i.e., less than = or less than1.5 mets of activity) measured by Motion Watch actigraphy

    Sedentary behaviour

    Measured: Baseline and 6 months

  51. Quality of life measured by EQ-5D-5L

    Quality of life

    Measured: Baseline, 3 months, 6 months, and 18 months

  52. Wellbeing measured by ICE-CAP

    Wellbeing

    Measured: Baseline, 3 months, 6 months, and 18 months

  53. Telemere length

    Marker of aging

    Measured: Baseline and 6 months

  54. Gait speed over 4-m walk

    Gait Speed

    Measured: Baseline, 6 months, and 18 months

  55. Brain Age as derived from T1 structural scans

    Brain Age

    Measured: Basline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study start13 Nov 2017
  3. Primary completion22 Aug 2024
  4. Study completion26 Aug 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02737878
Sponsor's protocol ID
H15-02181
Status last verified
Mar 2026
First submitted
11 Apr 2016
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Balbim GM, Boa Sorte Silva NC, Falck RS, Kramer AF, Voss MW, Liu-Ambrose T. 24-hour activity cycle behaviors and gray matter volume in mild cognitive impairment. Alzheimers Dement. 2025 Jul;21(7):e70496. doi: 10.1002/alz.70496.

    PubMed 40693459
  • Barha CK, Falck RS, Best JR, Nagamatsu LS, Hsiung GR, Sheel AW, Hsu CL, Kramer AF, Voss MW, Erickson KI, Davis JC, Shoemaker JK, Boyd L, Crockett RA, Ten Brinke L, Bherer L, Singer J, Galea LAM, Jacova C, Bullock A, Grant S, Liu-Ambrose T. Reshaping the path of mild cognitive impairment by refining exercise prescription: a study protocol of a randomized controlled trial to understand the "what," "for whom," and "how" of exercise to promote cognitive function. Trials. 2022 Sep 9;23(1):766. doi: 10.1186/s13063-022-06699-7.

    PubMed 36085237

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Training, Resistance Training and Balance and Tone Training in people with Mild Cognitive Impairment, 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 10 inclusion and 7 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 19 Mar 2026. 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?

Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02737878, which also lists 2 linked publications.

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 19 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in