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Completed

NCT Number: NCT02737878

Reshaping the Path of Mild Cognitive Impairment by Refining Exercise Prescription

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.

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Aerobic training

Behavioral

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 training

Behavioral

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 Training

Behavioral

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.

Primary outcomes

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

    Time frame: Baseline to 6 months

    Cognition

Secondary outcomes

  1. Executive functions as measured by standard neuropsychological and computerized tests

    Time frame: Baseline and 6 months and 18 months

    Executive functions

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

    Time frame: Baseline and 6 months and 18 months

    IIV of executive functions

  3. Cardiometabolic risk factors as measured by blood panel

    Time frame: Baseline and 6 months

    Cardiometabolic risk factors

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

    Time frame: Baseline, 3 months, 6 months, 12 months, and 18 months

    Quality of life

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

    Time frame: Baseline, 3 months, 6 months, 12 months, and 18 months

    Quality of life

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

    Time frame: Baseline and 6 months

    Depressive symptoms

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

    Time frame: Baseline and 6 months

    Brain function

  8. Brain structure as measured by structural magnetic resonance imaging

    Time frame: Baseline and 6 months

    Brain structure

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

    Time frame: Baseline and 6 months

    White matter lesion

  10. Diffusion tensor imaging as measured by magnetic resonance imaging

    Time frame: Baseline and 6 months

    White matter integrity

  11. Memory as measured by standard neuropsychological and computerized tests

    Time frame: Baseline and 6 months and 18 months

    Memory

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

    Time frame: Baseline and 6 months and 18 months

    IIV of memory

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

    Time frame: Baseline and 6 months

    Visualspatial ability

  14. Cardiorespiratory capacity as measured by treadmill test

    Time frame: Baseline and 6 months

    Cardiovascular fitness

  15. Mobility as measured by 400-m walk

    Time frame: Baseline and 6 months and 18 months

    Mobility

  16. Cardiorespiratory capacity esimated from 400-m walk

    Time frame: Baseline and 6 months and 18 months

    Estimated cardiovascular fitness

  17. Cardiometabolic risk as measured by waist to hip ratio

    Time frame: Baseline and 6 months and 18 months

    Cardiometabolic risk

  18. Cardiometabolic risk as measured by body mass index

    Time frame: Baseline and 6 months and 18 months.

    Cardiometabolic risk

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

    Time frame: Baseline and 6 months

    Cardiometabolic risk

  20. Cortisol levels through saliva samples (subset)

    Time frame: 5 times from baseline to 6 months

    Cortisol levels

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

    Time frame: Baseline and 6 months and 18 months

    Lower body strength

  22. Lower body strength as measured by Biodex

    Time frame: Baseline and 6 months

    Lower body strength

  23. Upper body strength as measured by grip strength

    Time frame: Baseline and 6 months

    Upper body strength

  24. Sleep quality as measured by Motion Watch actigraphy

    Time frame: Baseline and 6 months

    Sleep quality

  25. Neurotrophic factors as measured by blood

    Time frame: Baseline and 6 months

    Neurotrophic factors

  26. Mobility as measured by Short Physical Performance Battery

    Time frame: Baseline and 6 months and 18 months

    Mobility

  27. Community mobility as measured by the Life Space Questionnaire

    Time frame: Baseline, 3 months, 6 months, 12 months, and 18 months

    Mobility

  28. Body composition as measured by DXA

    Time frame: Baseline and 6 months

    Body composition (lean & fat mass)

  29. Loneliness as measured by the UCLA Loneliness Scale

    Time frame: Baseline and 6 months

    Loneliness

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

    Time frame: Baseline and 6 months and 18 months

    Cognitive function

  31. Sedentary behaviour as measure by the Sedentary Behaviour Questionnaire

    Time frame: Baseline, 3 months, 6 months, 12 months, and 18 months

    Sedentary behaviour

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

    Time frame: Baseline and 6 months

    Sleep apnea risk

  33. Prospective falls via Monthly Calendars

    Time frame: Baseline and 3 months and 6 months and monthly

    Accidental falls

  34. Social support as measured by Social Provision Scale

    Time frame: Baseline and 6 months

    Social support

  35. Mindfulness as measured by the Mindfulness Attention Awareness Scale

    Time frame: Baseline and 6 months

    Mindfulness

  36. Memory as measured by the Everyday Memory Questionnaire

    Time frame: Baseline and 6 months

    Memory

  37. Sleep as measured by the Pittsburgh Sleep Quality Index

    Time frame: Baseline, 6 months, 12 months, and 18 months

    Sleep

  38. Functional ability as measured by the Lawson IADL

    Time frame: Baseline and 6 months

    Instrumental activities of daily living

  39. Comorbidities as measured by the Function Comorbidity Index

    Time frame: Baseline, 6 months, 12 months, and 18 months

    Chronic conditions

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

    Time frame: Baseline and 6 months and 18 months

    Mood

  41. Social network as measured by Lubben Social Network Scale

    Time frame: Baseline and 6 months

    Social network

  42. Physical activity as measured by the CHAMP Questionnaire

    Time frame: Baseline and 3 months and 6 months and monthly

    Physical Activity Level

  43. ADAS-Cog Plus

    Time frame: 18 months

    Cognitive function

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

    Time frame: Baseline, 6 months, and 18 months

    Verbal memory and learning

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

    Time frame: Baseline, 6 months, and 18 months

    Verbal functioning tests requiring retrieval

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

    Time frame: Baseline and 6 months

    Cytokines

  47. Dual-task gait using Gaitrite

    Time frame: Baseline and 6 months

    Dual-task walking

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

    Time frame: Baseline, 3 months, and 6 months

    Access health system services/resources

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

    Time frame: Baseline and 6 months

    Physical activity levels

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

    Time frame: Baseline and 6 months

    Sedentary behaviour

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

    Time frame: Baseline, 3 months, 6 months, and 18 months

    Quality of life

  52. Wellbeing measured by ICE-CAP

    Time frame: Baseline, 3 months, 6 months, and 18 months

    Wellbeing

  53. Telemere length

    Time frame: Baseline and 6 months

    Marker of aging

  54. Gait speed over 4-m walk

    Time frame: Baseline, 6 months, and 18 months

    Gait Speed

  55. Brain Age as derived from T1 structural scans

    Time frame: Basline and 6 months

    Brain Age

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
Apr 14, 2016
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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