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Reshaping the Path of Vascular Cognitive Impairment (VCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02669394
Recruitment Status : Active, not recruiting
First Posted : February 1, 2016
Last Update Posted : March 18, 2022
Sponsor:
Information provided by (Responsible Party):
Teresa Liu-Ambrose, University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Transient Ischemic Attack Vascular Cognitive Impairment Subcortical Vascular Dementia Behavioral: Resistance exercise training Behavioral: Control: stretching and relaxation program Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reshaping the Path of Vascular Cognitive Impairment With Resistance Training
Actual Study Start Date : May 17, 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

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.

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).
Other Name: RT Program

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.

Behavioral: 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.
Other Name: CON Program




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Executive functions as measured by standard neuropsychological tests [ Time Frame: Baseline, 6 months, and 12 months ]
  2. Arterial stiffness as measured by carotid-femoral arterial pulse-wave velocity (PWV) [ Time Frame: Baseline and 12 months ]
  3. Cardiometabolic risk factors as measured by blood panel [ Time Frame: Baseline, 6 months, and 12 months ]
  4. Cardiometabolic risk factors as measured by body mass index [ Time Frame: baseline, 6 months, and 12 months ]
  5. Cardiometabolic risk factors as measured by waist to hip ratio [ Time Frame: baseline, 6 months, and 12 months ]
  6. Physiological falls risk as measured by the Physiological Profile Assessment [ Time Frame: baseline, 6 months, and 12 months ]
  7. Mobility and balance as measured by the Short Physical Performance Battery [ Time Frame: baseline, 6 months, and 12 months ]
  8. Mood as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: baseline, 6 months, and 12 months ]
  9. Quality of life as measured by the Medical Outcomes Study Short Form-6D (SF-6D) [ Time Frame: baseline, 6 months, and 12 months ]
  10. White matter integrity as measured by diffusion tensor imaging [ Time Frame: baseline and 12 months ]
  11. Myelin plasticity as measured by multicomponent relaxation imaging [ Time Frame: baseline and 12 months ]
  12. Memory as measured by standard neuropsychological tests [ Time Frame: baseline, 6 months, and 12 months ]
  13. Upper body strength as measured by grip strength [ Time Frame: baseline, 6 months, and 12 months ]
  14. Lower body strength as measured by 30 sec sit to stand test (subset only) [ Time Frame: baseline, 6 months, and 12 months ]
  15. Functional capacity as measured by 6 minute walk test [ Time Frame: Baseline, 6 months, 12 months ]
  16. Neurotrophic factors in blood: IGF-1, BDNF, VEGF (subset only) [ Time Frame: Baseline, 6 months, 12 months ]
  17. Self-reported physical activity as measured by the PASE questionnaire [ Time Frame: Monthly ]
  18. NIH Cognitive Toolbox [ Time Frame: Baseline, 6 months, 12 months ]
  19. Isokinetic strength of the lower limb (subset only) [ Time Frame: Baseline, 6 months, 12 months ]
  20. Functional connectivity using resting state fMRI (subset only) [ Time Frame: Baseline and 12 months ]
  21. Health resource utilization [ Time Frame: Baseline and every 3 months ]
  22. Prospective falls via monthly falls calendars [ Time Frame: Monthly ]
  23. Mobility using timed up and go test [ Time Frame: Baseline, 6 months, 12 months ]
  24. Dual-task ability using dual-task timed up and go test [ Time Frame: Baseline, 6 months, 12 months ]
  25. Dual task gait using Gaitrite mat (subset only) [ Time Frame: Baseline, 6 months, 12 months ]
  26. Cognitive function using ADAS-Cog 13 [ Time Frame: Baseline, 6 months, 12 months ]
  27. Dominant quad isometric strength using a strain gauge [ Time Frame: Baseline, 6 months, 12 months ]
  28. Hypothalamic-pituitary-adrenal axis activity using saliva samples (i.e., cortisol) (subset only) [ Time Frame: Baseline, 6 months, 12 months ]
  29. Regional brain volumes using structural MRI [ Time Frame: Baseline and 12 months ]
  30. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669394


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
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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
Principal Investigator: Roger Tam, PhD University of British Columbia
Principal Investigator: Thalia Field, MD University of British Columbia
Principal Investigator: Kenneth Madden, MD University of British Columbia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Teresa Liu-Ambrose, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02669394    
Other Study ID Numbers: H15-00972
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Dementia, Vascular
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Brain Ischemia
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases