- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02669394
Reshaping the Path of Vascular Cognitive Impairment (VCI)
Reshaping the Path of Vascular Cognitive Impairment With Resistance Training
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- University of British Columbia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- Montreal Cognitive Assessment (MoCA) score less than 26 at screening;
- MMSE score of = or > 20 at screening;
- Community-dwelling;
- Lives in Metro Vancouver;
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resistance Training (RT)
The 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. |
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).
Other Names:
|
Active Comparator: Stretching and Relaxation (CON)
The 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. |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function as measured by Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus)
Time Frame: Baseline, 6 months, and 12 months
|
ADAS-Cog 13 Plus additional cognitive tests
|
Baseline, 6 months, and 12 months
|
Change in white matter health as measured by total white matter lesion volume
Time Frame: Baseline to 12 months
|
White matter hyperintensity volume in mm3
|
Baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Executive functions as measured by standard neuropsychological tests
Time Frame: Baseline, 6 months, and 12 months
|
Baseline, 6 months, and 12 months
|
|
Cardiometabolic risk factors as measured by body mass index
Time Frame: baseline, 6 months, and 12 months
|
baseline, 6 months, and 12 months
|
|
Cardiometabolic risk factors as measured by waist to hip ratio
Time Frame: baseline, 6 months, and 12 months
|
baseline, 6 months, and 12 months
|
|
Physiological falls risk as measured by the Physiological Profile Assessment
Time Frame: baseline, 6 months, and 12 months
|
baseline, 6 months, and 12 months
|
|
Mobility and balance as measured by the Short Physical Performance Battery
Time Frame: baseline, 6 months, and 12 months
|
baseline, 6 months, and 12 months
|
|
Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: baseline, 6 months, and 12 months
|
baseline, 6 months, and 12 months
|
|
Quality of life as measured by the Medical Outcomes Study Short Form-6D (SF-6D)
Time Frame: baseline, 6 months, and 12 months
|
baseline, 6 months, and 12 months
|
|
White matter integrity as measured by diffusion tensor imaging
Time Frame: baseline and 12 months
|
baseline and 12 months
|
|
Myelin plasticity as measured by multicomponent relaxation imaging
Time Frame: baseline and 12 months
|
baseline and 12 months
|
|
Memory as measured by standard neuropsychological tests
Time Frame: baseline, 6 months, and 12 months
|
baseline, 6 months, and 12 months
|
|
Upper body strength as measured by grip strength
Time Frame: baseline, 6 months, and 12 months
|
baseline, 6 months, and 12 months
|
|
Functional capacity as measured by 6 minute walk test
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
|
Neurotrophic factors in blood: IGF-1, BDNF, VEGF (subset only)
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
|
Self-reported physical activity as measured by the PASE questionnaire
Time Frame: Monthly
|
Monthly
|
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NIH Cognitive Toolbox
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
|
Isokinetic strength of the lower limb (subset only)
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
|
Functional connectivity using resting state fMRI (subset only)
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
|
Health resource utilization
Time Frame: Baseline and every 3 months
|
Baseline and every 3 months
|
|
Prospective falls via monthly falls calendars
Time Frame: Monthly
|
Monthly
|
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Dual-task ability using dual-task timed up and go test
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
|
Dual task gait using Gaitrite mat (subset only)
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
|
Cognitive function using ADAS-Cog 13
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
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Dominant quad isometric strength using a strain gauge
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
|
Hypothalamic-pituitary-adrenal axis activity using saliva samples (i.e., cortisol) (subset only)
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
|
Regional brain volumes using structural MRI
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
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Selected Pro- and anti-inflammatory cytokines in blood (subset only)
Time Frame: Baseline, 6 months, and 12 months
|
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
|
Cardiometabolic risk factors as measured by blood panel (subset only)
Time Frame: Baseline, 6 months, and 12 months
|
Baseline, 6 months, and 12 months
|
|
Arterial stiffness as measured by carotid-femoral arterial pulse-wave velocity (PWV) (subset only)
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
|
Lower body strength as measured by 30 sec sit to stand test
Time Frame: baseline, 6 months, and 12 months
|
baseline, 6 months, and 12 months
|
|
Mobility using Timed up and Go Test
Time Frame: Baseline, 6 months, 12 months
|
Baseline, 6 months, 12 months
|
|
Telomere Length (subset only)
Time Frame: Baseline, 6 months, and 12 months
|
Baseline, 6 months, and 12 months
|
|
Sleep quality as measured by MW8
Time Frame: Baseline, 6 months, and 12 months
|
Baseline, 6 months, and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kenneth Madden, MD, University of British Columbia
- Principal Investigator: Roger Tam, PhD, University of British Columbia
- Principal Investigator: Thalia Field, MD, University of British Columbia
- Principal Investigator: Teresa Liu-Ambrose, PhD, PT, University of British Columbia
- Principal Investigator: John Best, PhD, University of British Columbia
- Principal Investigator: Jennifer Davis, PhD, University of British Columbia
- Principal Investigator: Charlie Goldsmith, PhD, Simon Fraser University
- Principal Investigator: Ging-Yuek Robin Hsiung, MD, PhD, University of British Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Brain Ischemia
- Dementia
- Cognition Disorders
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Ischemic Attack, Transient
- Cognitive Dysfunction
- Dementia, Vascular
Other Study ID Numbers
- H15-00972
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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