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Completed

NCT Number: NCT02669394

Reshaping the Path of Vascular Cognitive Impairment (VCI)

The investigators will conduct a proof-of-concept randomized controlled trial study to provide preliminary evidence of efficacy of a resistance exercise training program for maintaining white matter health and improving cognitive function in older adults with vascular cognitive impairment, defined as the presence of cognitive impairment combined with cerebral small vessel disease, compared with a stretch and relaxation program.

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Key information

About this study

A total of 88 adults with vascular cognitive impairment will be randomized to either a 12-month twice-weekly resistance training program or stretch and relaxation program. There will be three measurement sessions: baseline, 6 months (midpoint of intervention period), and 12 months (end of intervention period).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The study will specifically recruit individuals who fulfill the diagnostic criteria for SIVCI -- the presence of both cognitive impairment and small vessel ischaemic disease.

Specifically, individuals must meet the following inclusion criteria:

  • Montreal Cognitive Assessment (MoCA) score less than 26 at screening;
  • MMSE score of = or > 20 at screening;
  • Community-dwelling;
  • Lives in Metro Vancouver;
  • Able to comply with scheduled visits, treatment plan, and other trial procedures;
  • Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity;
  • Stable on a fixed dose of cognitive medications (e.g., donepezil, galantamine, rivastigmine, memantine, etc.) that is not expected to change during the 12-month study period, or, if they are not on any of these medications, they are not expected to start them during the 12-month study period;
  • 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;
  • Able to walk independently; and
  • Must be in sufficient health to participate in study's aerobic-based exercise training program. This will be based on medical history, vital signs, physical examination by study physicians, and written recommendation by family physician indicating individual's appropriateness to participate in an aerobic-based exercise training program.

Exclusion criteria

  • Absence of relevant small vessel ischaemic lesions on an existing brain computed tomography (CT) or MRI;
  • Diagnosed with another type of dementia (e.g., AD) or other neurological conditions (e.g., multiple sclerosis, Parkinson's disease, etc.) that affects cognition and mobility;
  • Diagnosed previously with a genetic cause of SIVCI (e.g., CADASIL);
  • At high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
  • Participating in regular RT in the last six months;
  • Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
  • Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.); or
  • Individual who plans to participate or is enrolled in a clinical drug trial concurrent to this study.
  • Unable to meet the specific scanning requirements of the UBC 3T MRI Research Centre. Specifically, we will exclude anyone with: pacemaker, brain aneurysm clip, cochlear implant, recent surgery or tattoos within the past 6 weeks, electrical stimulator for nerves or bones, implanted infusion pump, history of any eye injury involving metal fragments, artificial heart valve, orthopedic hardware, other metallic prostheses, coil, catheter or filter in any blood vessel, ear or eye implant, bullets, or other metallic fragments.

Treatment and study plan

Resistance Exercise Training

Behavioral

Twelve 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).

Other names: RT Program

Control: stretching and relaxation program

Behavioral

Twelve months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. Each session will be 60 minutes.

Other names: CON Program

Primary outcomes

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

    Time frame: Baseline, 6 months, and 12 months

    ADAS-Cog 13 Plus additional cognitive tests

  2. Change in white matter health as measured by total white matter lesion volume

    Time frame: Baseline to 12 months

    White matter hyperintensity volume in mm3

Secondary outcomes

  1. Executive functions as measured by standard neuropsychological tests

    Time frame: Baseline, 6 months, and 12 months

  2. Arterial stiffness as measured by carotid-femoral arterial pulse-wave velocity (PWV) (subset only)

    Time frame: Baseline and 12 months

  3. Cardiometabolic risk factors as measured by blood panel (subset only)

    Time frame: Baseline, 6 months, and 12 months

  4. Cardiometabolic risk factors as measured by body mass index

    Time frame: baseline, 6 months, and 12 months

  5. Cardiometabolic risk factors as measured by waist to hip ratio

    Time frame: baseline, 6 months, and 12 months

  6. Physiological falls risk as measured by the Physiological Profile Assessment

    Time frame: baseline, 6 months, and 12 months

  7. Mobility and balance as measured by the Short Physical Performance Battery

    Time frame: baseline, 6 months, and 12 months

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

    Time frame: baseline, 6 months, and 12 months

  9. Quality of life as measured by the Medical Outcomes Study Short Form-6D (SF-6D)

    Time frame: baseline, 6 months, and 12 months

  10. White matter integrity as measured by diffusion tensor imaging

    Time frame: baseline and 12 months

  11. Myelin plasticity as measured by multicomponent relaxation imaging

    Time frame: baseline and 12 months

  12. Memory as measured by standard neuropsychological tests

    Time frame: baseline, 6 months, and 12 months

  13. Upper body strength as measured by grip strength

    Time frame: baseline, 6 months, and 12 months

  14. Lower body strength as measured by 30 sec sit to stand test

    Time frame: baseline, 6 months, and 12 months

  15. Functional capacity as measured by 6 minute walk test

    Time frame: Baseline, 6 months, 12 months

  16. Neurotrophic factors in blood: IGF-1, BDNF, VEGF (subset only)

    Time frame: Baseline, 6 months, 12 months

  17. Self-reported physical activity as measured by the PASE questionnaire

    Time frame: Monthly

  18. NIH Cognitive Toolbox

    Time frame: Baseline, 6 months, 12 months

  19. Isokinetic strength of the lower limb (subset only)

    Time frame: Baseline, 6 months, 12 months

  20. Functional connectivity using resting state fMRI (subset only)

    Time frame: Baseline and 12 months

  21. Health resource utilization

    Time frame: Baseline and every 3 months

  22. Prospective falls via monthly falls calendars

    Time frame: Monthly

  23. Mobility using Timed up and Go Test

    Time frame: Baseline, 6 months, 12 months

  24. Dual-task ability using dual-task timed up and go test

    Time frame: Baseline, 6 months, 12 months

  25. Dual task gait using Gaitrite mat (subset only)

    Time frame: Baseline, 6 months, 12 months

  26. Cognitive function using ADAS-Cog 13

    Time frame: Baseline, 6 months, 12 months

  27. Dominant quad isometric strength using a strain gauge

    Time frame: Baseline, 6 months, 12 months

  28. Hypothalamic-pituitary-adrenal axis activity using saliva samples (i.e., cortisol) (subset only)

    Time frame: Baseline, 6 months, 12 months

  29. Regional brain volumes using structural MRI

    Time frame: Baseline and 12 months

  30. Selected Pro- and anti-inflammatory cytokines in blood (subset only)

    Time frame: Baseline, 6 months, and 12 months

    IFN-alpha, IL-1 alpha, IL-4, IL-6, IL-10, IL-12p70, IL-13, IL-17, TNF-alpha, Rantes, CXCL1, IL-18, TGF-B

  31. Telomere Length (subset only)

    Time frame: Baseline, 6 months, and 12 months

  32. Sleep quality as measured by MW8

    Time frame: Baseline, 6 months, and 12 months

  33. Brain Age as derived from structural scans

    Time frame: Baseline and 12 months

    Brain Age

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Reshaping the Path of Vascular Cognitive Impairment With Resistance Training

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2016
Registry last updated
Mar 17, 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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