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Vascular Cognitive ImpairmentNCT01027858

PROMOTE: Promotion of the Mind Through Exercise

A study testing Aerobic-based exercise training in people with 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 study to provide preliminary evidence of efficacy of aerobic-based exercise training for maintaining cognitive function, executive function, and everyday function in adults with mild vascular cognitive impairment. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Vascular Cognitive Impairment
What is being tested?
Aerobic-based exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteCanada
Study dates
Dec 2009to May 2015
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 45 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 as outlined by Erkinjuntti and colleagues (1), which requires the presence of both cognitive syndrome (as defined in Section A below) and small vessel ischaemic disease (as defined in Section B below).
  • Cognitive Syndrome defined as:
  • Dysexecutive Syndrome: Some impairment in goal formulation, initiation, planning, organizing, sequencing, executing, set-shifting and maintenance, or abstracting.
  • Memory Deficit: Some impairment in recall, relative intact recognition, less severe forgetting, benefit from cues.
  • Progression: Deterioration of A1 and A2 from a previous higher level of functioning that are not per se interfering with complex occupational and social activities.
  • Small Vessel Ischaemic Disease defined as:
Show all 21Show fewer
  • Evidence of relevant cerebrovascular disease by brain imaging (in the last 12 months) defined as the presence of both:
  • Periventricular and deep white matter lesions: Patchy areas of low attenuation (intermediate density between that of normal white matter and that of intraventricular cerebro-spinal fluid) or diffuse symmetrical areas of low attenuation with ill defined margins extending to the centrum semiovale plus at least one lacunar infarct (correlating to the white matter grading scale greater than 3 from the Cardiovascular Health Study) (2,3); and ii. Absence of cortical and/or cortico-sub-cortical non-lacunar territorial infarcts and watershed infarcts, haemorrhages indicating large vessel disease, signs of normal pressure hydrocephalus, or other specific causes of white matter lesions (e.g., multiple sclerosis, leukodystrophies, sarcoidosis, brain irradiation, etc).
  • Presence or a history of neurological signs as evidence for cerebrovascular disease such as hemiparesis, lower facial weakness, Babinski sign, sensory deficit, dysarthria, gait disorder, extrapyramidal signs consistent with sub-cortical brain lesion(s).
  • In addition, individuals must meet the following inclusion criteria:
  • Montreal Cognitive Assessment (MoCA) (4) score less than 26 at screening;
  • MMSE (5) score of > 20 at screening;
  • Community-dwelling;
  • Lives in Metro Vancouver;
  • Have a caregiver, family member, or friend who interacts with him/her on a weekly basis;
  • 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;
  • 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);
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of British Columbia

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: Role of Exercise on Cognition and Function in Seniors With Vascular Cognitive Impairment: A Randomized Controlled Trial

The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of aerobic-based exercise training for maintaining cognitive function, executive function, and everyday function in adults with mild vascular cognitive impairment.

Read the detailed description

A total of 70 adults diagnosed with Ischaemic Vascular Cognitive Impairment (SIVCI) will be randomized to either a 6 month thrice weekly walking program or usual care. After 6 months of intervention, they will be followed for an additional 6 months. There will be three measurement sessions: baseline, 6 months (end of intervention period); and 12 months.

Being tested
Aerobic-based exercise training, CON (control; usual care)
Keywords
exercise, aerobic exercise training, vascular cognitive impairment, Mild Sub-cortical Ischaemic Vascular Cognitive Impairment (SIVCI)
Medical subject headings
Motor Activity

What participants receive

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

  • Aerobic-based exercise trainingBehavioural

    Six months of thrice-weekly walking 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).

  • CON (control; usual care)Behavioural

    Nutrition education and usual care as prescribed by neurologist

Study groups in NCT01027858
Study groupRoleWhat they receive
1ExperimentalAT (aerobic-based exercise training)
Receives: Behavioral: Aerobic-based exercise training
2Active comparatorCON (control; usual care)
Receives: Behavioral: CON (control; usual care)

What is being measured

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

  1. This is a proof-of-concept study. The primary endpoints are: ADAS-Cog

    Measured: baseline, 6 months, and 12 months

  2. EXIT-25

    Measured: baseline, 6 months, and 12 months

  3. ADCS-ADL

    Measured: baseline, 6 months, and 12 months

Secondary outcomes (4)
  1. Secondary outcomes of interest include: performance of specific executive processes

    Measured: baseline, 6 months, and 12 months

  2. Physical function

    Measured: baseline, 6 months, and 12 months

  3. Inflammatory biomarkers

    Measured: baseline, 6 months, and 12 months

  4. Serum glucose and lipids. These will be assessed at 6 and 12 months.

    Measured: baseline, 6 months, 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 posted9 Dec 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2014
  4. Study completionMay 2015

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
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01027858
Sponsor's protocol ID
H09-00529
Status last verified
Feb 2022
First submitted
7 Dec 2009
Last updated
25 Feb 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu-Ambrose T, Best JR, Davis JC, Eng JJ, Lee PE, Jacova C, Boyd LA, Brasher PM, Munkacsy M, Cheung W, Hsiung GR. Aerobic exercise and vascular cognitive impairment: A randomized controlled trial. Neurology. 2016 Nov 15;87(20):2082-2090. doi: 10.1212/WNL.0000000000003332. Epub 2016 Oct 19.

    PubMed 27760869
  • Liu-Ambrose T, Eng JJ, Boyd LA, Jacova C, Davis JC, Bryan S, Lee P, Brasher P, Hsiung GY. Promotion of the mind through exercise (PROMoTE): a proof-of-concept randomized controlled trial of aerobic exercise training in older adults with vascular cognitive impairment. BMC Neurol. 2010 Feb 17;10:14. doi: 10.1186/1471-2377-10-14.

    PubMed 20158920
  • Hsu CL, Best JR, Davis JC, Nagamatsu LS, Wang S, Boyd LA, Hsiung GR, Voss MW, Eng JJ, Liu-Ambrose T. Aerobic exercise promotes executive functions and impacts functional neural activity among older adults with vascular cognitive impairment. Br J Sports Med. 2018 Feb;52(3):184-191. doi: 10.1136/bjsports-2016-096846. Epub 2017 Apr 21.

    PubMed 28432077
  • Barha CK, Hsiung GR, Best JR, Davis JC, Eng JJ, Jacova C, Lee PE, Munkacsy M, Cheung W, Liu-Ambrose T. Sex Difference in Aerobic Exercise Efficacy to Improve Cognition in Older Adults with Vascular Cognitive Impairment: Secondary Analysis of a Randomized Controlled Trial. J Alzheimers Dis. 2017;60(4):1397-1410. doi: 10.3233/JAD-170221.

    PubMed 29036816
  • Dao E, Barha CK, Best JR, Hsiung GY, Tam R, Liu-Ambrose T. The Effect of Aerobic Exercise on White Matter Hyperintensity Progression May Vary by Sex. Can J Aging. 2019 Jun;38(2):236-244. doi: 10.1017/S0714980818000582. Epub 2019 Mar 14.

    PubMed 30867079
  • A history of the Arkansas State Dental Hygienists Association. Ark Dent J. 1987 Apr;58(1):43. No abstract available.

    PubMed 3107531
  • Barha CK, Dao E, Marcotte L, Hsiung GR, Tam R, Liu-Ambrose T. Cardiovascular risk moderates the effect of aerobic exercise on executive functions in older adults with subcortical ischemic vascular cognitive impairment. Sci Rep. 2021 Oct 7;11(1):19974. doi: 10.1038/s41598-021-99249-1.

    PubMed 34620933
  • Barha CK, Starkey SY, Hsiung GYR, Tam R, Liu-Ambrose T. Aerobic exercise improves executive functions in females, but not males, without the BDNF Val66Met polymorphism. Biol Sex Differ. 2023 Apr 3;14(1):16. doi: 10.1186/s13293-023-00499-7.

    PubMed 37013586
  • Barha CK, Hsiung GYR, Liu-Ambrose T. The Role of S100B in Aerobic Training Efficacy in Older Adults with Mild Vascular Cognitive Impairment: Secondary Analysis of a Randomized Controlled Trial. Neuroscience. 2019 Jul 1;410:176-182. doi: 10.1016/j.neuroscience.2019.04.052. Epub 2019 May 7.

    PubMed 31075314
  • Dao E, Best JR, Hsiung GR, Sossi V, Jacova C, Tam R, Liu-Ambrose T. Associations between cerebral amyloid and changes in cognitive function and falls risk in subcortical ischemic vascular cognitive impairment. BMC Geriatr. 2017 Jun 28;17(1):133. doi: 10.1186/s12877-017-0522-4.

    PubMed 28659161
  • Davis JC, Hsiung GR, Bryan S, Best JR, Eng JJ, Munkacsy M, Cheung W, Chiu B, Jacova C, Lee P, Liu-Ambrose T. Economic evaluation of aerobic exercise training in older adults with vascular cognitive impairment: PROMoTE trial. BMJ Open. 2017 Mar 29;7(3):e014387. doi: 10.1136/bmjopen-2016-014387.

    PubMed 28360247
  • Davis JC, Hsiung GY, Bryan S, Jacova C, Jacova P, Munkacsy M, Cheung W, Lee P, Liu-Ambrose T. Agreement between Patient and Proxy Assessments of Quality of Life among Older Adults with Vascular Cognitive Impairment Using the EQ-5D-3L and ICECAP-O. PLoS One. 2016 Apr 21;11(4):e0153878. doi: 10.1371/journal.pone.0153878. eCollection 2016.

    PubMed 27101402
  • Dao E, Hsiung GY, Sossi V, Jacova C, Tam R, Dinelle K, Best JR, Liu-Ambrose T. Exploring the effects of coexisting amyloid in subcortical vascular cognitive impairment. BMC Neurol. 2015 Oct 12;15:197. doi: 10.1186/s12883-015-0459-1.

    PubMed 26459220

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic-based exercise training in people with 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 21 inclusion and 6 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 25 Feb 2022. 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?

This is a proof-of-concept study. The primary endpoints are: ADAS-Cog (time frame: baseline, 6 months, and 12 months). The study lists 3 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 NCT01027858, which also lists 13 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 25 Feb 2022.

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