An interventional study of Aerobic-based exercise training and CON (control; usual care) in Vascular Cognitive Impairment, sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2022-02-25.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 71 is close to the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
A. Cognitive Syndrome defined as:
B. Small Vessel Ischaemic Disease defined as:
Evidence of relevant cerebrovascular disease by brain imaging (in the last 12 months) defined as the presence of both:
i. 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).
In addition, individuals must meet the following inclusion criteria:
Exclusion Criteria:
AT (aerobic-based exercise training)
Behavioral: Aerobic-based exercise training
CON (control; usual care)
Behavioral: CON (control; usual care)
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).
Nutrition education and usual care as prescribed by neurologist
This is a proof-of-concept study. The primary endpoints are: ADAS-Cog
Time frame: baseline, 6 months, and 12 months
EXIT-25
Time frame: baseline, 6 months, and 12 months
ADCS-ADL
Time frame: baseline, 6 months, and 12 months
Secondary outcomes of interest include: performance of specific executive processes
Time frame: baseline, 6 months, and 12 months
Physical function
Time frame: baseline, 6 months, and 12 months
Inflammatory biomarkers
Time frame: baseline, 6 months, and 12 months
Serum glucose and lipids. These will be assessed at 6 and 12 months.
Time frame: baseline, 6 months, and 12 months
Brain Structure
Volume and white matter lesions.
Time frame: Baseline and 6 months
Brain Function
fMRI and resting state
Time frame: Baseline and 6 months
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University of British Columbia