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Transient Ischemic AttackNCT02669394

Reshaping the Path of Vascular Cognitive Impairment (VCI)

A study testing Resistance exercise training in people with Transient Ischemic Attack and Vascular 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
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Trial summary

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… Read more about this study

Who is it for?
Ages 55 years and older
What is being tested?
Resistance exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteCanada
Study dates
17 May 2016to 2 Jun 2022
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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

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 Vascular Cognitive Impairment With Resistance Training

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.

Read the detailed description

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).

Being tested
Resistance exercise training, Control: stretching and relaxation program
Medical subject headings
Ischemic Attack, Transient, Dementia, Vascular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance exercise trainingBehavioural

    Also called RT Program

    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).

  • Control: stretching and relaxation programBehavioural

    Also called CON Program

    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.

Study groups in NCT02669394
Study groupRoleWhat they receive
Resistance Training (RT)ExperimentalThe RT program will be a twice-weekly program. A pressurized air system and free weights will be used . The pressurized air system exercises will consist of biceps curls, triceps extension, seated row, latissmus dorsi pull downs, leg press, hamstring curls, and calf raises. Other exercises, with free weights, will include mini-squats, mini-lunges, and lunge walks. The intensity of the training stimulus will initially be at 50% to 60% of 1 repetition maximum (RM) as determined at week two, and progress to 75% to 85% of 1-RM at a work level of 6 to 8 repetitions (2 sets) by week four. The training stimulus will be increased using the 7 RM method. 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 compliance.
Receives: Behavioral: Resistance exercise training
Stretching and Relaxation (CON)Active comparatorThe CON program will be a twice-weekly program. The CON group will consist of stretching exercises, basic core-strength/kegal exercises, and relaxation techniques. Other than bodyweight, no additional loading (e.g., hand weights, resistance bands, etc.) will be applied to any of the exercises. To meet the public health mandates of COVID-19, when it is necessary, training will occur at home. 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 compliance.
Receives: Behavioral: Control: stretching and relaxation program

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)

    ADAS-Cog 13 Plus additional cognitive tests

    Measured: Baseline, 6 months, and 12 months

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

    White matter hyperintensity volume in mm3

    Measured: Baseline to 12 months

Secondary outcomes (33)
  1. Executive functions as measured by standard neuropsychological tests

    Measured: Baseline, 6 months, and 12 months

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

    Measured: Baseline and 12 months

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

    Measured: Baseline, 6 months, and 12 months

  4. Cardiometabolic risk factors as measured by body mass index

    Measured: baseline, 6 months, and 12 months

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

    Measured: baseline, 6 months, and 12 months

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

    Measured: baseline, 6 months, and 12 months

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

    Measured: baseline, 6 months, and 12 months

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

    Measured: baseline, 6 months, and 12 months

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

    Measured: baseline, 6 months, and 12 months

  10. White matter integrity as measured by diffusion tensor imaging

    Measured: baseline and 12 months

  11. Myelin plasticity as measured by multicomponent relaxation imaging

    Measured: baseline and 12 months

  12. Memory as measured by standard neuropsychological tests

    Measured: baseline, 6 months, and 12 months

  13. Upper body strength as measured by grip strength

    Measured: baseline, 6 months, and 12 months

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

    Measured: baseline, 6 months, and 12 months

  15. Functional capacity as measured by 6 minute walk test

    Measured: Baseline, 6 months, 12 months

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

    Measured: Baseline, 6 months, 12 months

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

    Measured: Monthly

  18. NIH Cognitive Toolbox

    Measured: Baseline, 6 months, 12 months

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

    Measured: Baseline, 6 months, 12 months

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

    Measured: Baseline and 12 months

  21. Health resource utilization

    Measured: Baseline and every 3 months

  22. Prospective falls via monthly falls calendars

    Measured: Monthly

  23. Mobility using Timed up and Go Test

    Measured: Baseline, 6 months, 12 months

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

    Measured: Baseline, 6 months, 12 months

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

    Measured: Baseline, 6 months, 12 months

  26. Cognitive function using ADAS-Cog 13

    Measured: Baseline, 6 months, 12 months

  27. Dominant quad isometric strength using a strain gauge

    Measured: Baseline, 6 months, 12 months

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

    Measured: Baseline, 6 months, 12 months

  29. Regional brain volumes using structural MRI

    Measured: Baseline and 12 months

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

    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

    Measured: Baseline, 6 months, and 12 months

  31. Telomere Length (subset only)

    Measured: Baseline, 6 months, and 12 months

  32. Sleep quality as measured by MW8

    Measured: Baseline, 6 months, and 12 months

  33. Brain Age as derived from structural scans

    Brain Age

    Measured: Baseline and 12 months

Timeline

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

  1. First posted1 Feb 2016 (estimated)
  2. Study start17 May 2016
  3. Primary completion2 Jun 2022
  4. Study completion2 Jun 2022

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02669394
Sponsor's protocol ID
H15-00972
Status last verified
Mar 2026
First submitted
14 Jan 2016
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Boa Sorte Silva NC, Tam RC, Alkeridy WA, Lam K, Dao E, Barha CK, Falck RS, Hsu CL, Hsiung GR, Madden KM, Field TS, Liu-Ambrose T. Exercise and white matter hyperintensities: a randomized clinical trial. Brain Commun. 2026 Oct 8;8(5):fcag381. doi: 10.1093/braincomms/fcag381. eCollection 2026.

    PubMed 42948654
  • Falck RS, Barha CK, Stein RG, Grant S, Bullock A, Madden KM, Davis JC, Tam R, Liu-Ambrose T. Resistance training and depressive symptoms in subcortical vascular cognitive impairment: secondary results of a randomised clinical trial. Br J Sports Med. 2026 Sep 3:bjsports-2026-112111. doi: 10.1136/bjsports-2026-112111. Online ahead of print.

    PubMed 42692806
  • Gu Y, Hsu CL, Boa Sorte Silva NC, Tam RC, Alkeridy WA, Lam K, Liu-Ambrose T. Probing cognitive reserve with resting state functional connectivity in subcortical ischemic vascular cognitive impairment. J Alzheimers Dis Rep. 2026 Jan 6;10:25424823251409395. doi: 10.1177/25424823251409395. eCollection 2026 Jan-Dec.

    PubMed 41929984
  • Liu-Ambrose T, Falck RS, Dao E, Crockett RA, Barha CK, Silva NCBS, Alkeridy WA, Best JR, Hsiung GR, Field TS, Madden KM, Davis JC, Ten Brinke LF, Tam RC. Resistance training and subcortical vascular cognitive impairment: A 12-month randomized trial. Alzheimers Dement. 2026 Mar;22(3):e71245. doi: 10.1002/alz.71245.

    PubMed 41795685
  • 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
  • Liu-Ambrose T, Dao E, Crockett RA, Barha CK, Falck RS, Best JR, Hsiung GR, Field TS, Madden KM, Alkeridy WA, Boa Sorte Silva NC, Davis JC, Ten Brinke LF, Doherty S, Tam RC. Reshaping the path of vascular cognitive impairment with resistance training: a study protocol for a randomized controlled trial. Trials. 2021 Mar 18;22(1):217. doi: 10.1186/s13063-021-05156-1.

    PubMed 33736706

Questions about this trial

What is this clinical trial studying?

A study testing Resistance exercise training in people with Transient Ischemic Attack and Vascular 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 12 inclusion and 9 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 17 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, 6 months, and 12 months). The study lists 2 primary outcomes in all. 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 NCT02669394, which also lists 6 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 17 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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