Transient Ischemic Attack Clinical Trial
Official title:
Reshaping the Path of Vascular Cognitive Impairment With Resistance Training
NCT number | NCT02669394 |
Other study ID # | H15-00972 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 17, 2016 |
Est. completion date | June 2, 2022 |
Verified date | January 2024 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 91 |
Est. completion date | June 2, 2022 |
Est. primary completion date | June 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | 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: 1. Montreal Cognitive Assessment (MoCA) score less than 26 at screening; 2. MMSE score of = or > 20 at screening; 3. Community-dwelling; 4. Lives in Metro Vancouver; 5. Able to comply with scheduled visits, treatment plan, and other trial procedures; 6. Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity; 7. 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; 8. 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; 9. Able to walk independently; and 10. 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: 1. Absence of relevant small vessel ischaemic lesions on an existing brain computed tomography (CT) or MRI; 2. 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; 3. Diagnosed previously with a genetic cause of SIVCI (e.g., CADASIL); 4. 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); 5. Participating in regular RT in the last six months; 6. Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility; 7. 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 8. Individual who plans to participate or is enrolled in a clinical drug trial concurrent to this study. 9. 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) | ADAS-Cog 13 Plus additional cognitive tests | Baseline, 6 months, and 12 months | |
Primary | Change in white matter health as measured by total white matter lesion volume | White matter hyperintensity volume in mm3 | Baseline to 12 months | |
Secondary | Executive functions as measured by standard neuropsychological tests | Baseline, 6 months, and 12 months | ||
Secondary | Arterial stiffness as measured by carotid-femoral arterial pulse-wave velocity (PWV) (subset only) | Baseline and 12 months | ||
Secondary | Cardiometabolic risk factors as measured by blood panel (subset only) | Baseline, 6 months, and 12 months | ||
Secondary | Cardiometabolic risk factors as measured by body mass index | baseline, 6 months, and 12 months | ||
Secondary | Cardiometabolic risk factors as measured by waist to hip ratio | baseline, 6 months, and 12 months | ||
Secondary | Physiological falls risk as measured by the Physiological Profile Assessment | baseline, 6 months, and 12 months | ||
Secondary | Mobility and balance as measured by the Short Physical Performance Battery | baseline, 6 months, and 12 months | ||
Secondary | Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) | baseline, 6 months, and 12 months | ||
Secondary | Quality of life as measured by the Medical Outcomes Study Short Form-6D (SF-6D) | baseline, 6 months, and 12 months | ||
Secondary | White matter integrity as measured by diffusion tensor imaging | baseline and 12 months | ||
Secondary | Myelin plasticity as measured by multicomponent relaxation imaging | baseline and 12 months | ||
Secondary | Memory as measured by standard neuropsychological tests | baseline, 6 months, and 12 months | ||
Secondary | Upper body strength as measured by grip strength | baseline, 6 months, and 12 months | ||
Secondary | Lower body strength as measured by 30 sec sit to stand test | baseline, 6 months, and 12 months | ||
Secondary | Functional capacity as measured by 6 minute walk test | Baseline, 6 months, 12 months | ||
Secondary | Neurotrophic factors in blood: IGF-1, BDNF, VEGF (subset only) | Baseline, 6 months, 12 months | ||
Secondary | Self-reported physical activity as measured by the PASE questionnaire | Monthly | ||
Secondary | NIH Cognitive Toolbox | Baseline, 6 months, 12 months | ||
Secondary | Isokinetic strength of the lower limb (subset only) | Baseline, 6 months, 12 months | ||
Secondary | Functional connectivity using resting state fMRI (subset only) | Baseline and 12 months | ||
Secondary | Health resource utilization | Baseline and every 3 months | ||
Secondary | Prospective falls via monthly falls calendars | Monthly | ||
Secondary | Mobility using Timed up and Go Test | Baseline, 6 months, 12 months | ||
Secondary | Dual-task ability using dual-task timed up and go test | Baseline, 6 months, 12 months | ||
Secondary | Dual task gait using Gaitrite mat (subset only) | Baseline, 6 months, 12 months | ||
Secondary | Cognitive function using ADAS-Cog 13 | Baseline, 6 months, 12 months | ||
Secondary | Dominant quad isometric strength using a strain gauge | Baseline, 6 months, 12 months | ||
Secondary | Hypothalamic-pituitary-adrenal axis activity using saliva samples (i.e., cortisol) (subset only) | Baseline, 6 months, 12 months | ||
Secondary | Regional brain volumes using structural MRI | Baseline and 12 months | ||
Secondary | 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 | Baseline, 6 months, and 12 months | |
Secondary | Telomere Length (subset only) | Baseline, 6 months, and 12 months | ||
Secondary | Sleep quality as measured by MW8 | Baseline, 6 months, and 12 months |
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