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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date January 2024
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 cognitive impairment combined with cerebral small vessel disease, compared with a stretch and relaxation program.


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).


Recruitment information / eligibility

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.

Study Design


Intervention

Behavioral:
Resistance exercise training
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 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.

Locations

Country Name City State
Canada University of British Columbia Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

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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