PROMOTE: Promotion of the Mind Through Exercise

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of British Columbia
Sponsor:
Collaborators:
Canadian Stroke Network
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01027858
First received: December 7, 2009
Last updated: February 20, 2014
Last verified: February 2014

December 7, 2009
February 20, 2014
December 2009
February 2014   (final data collection date for primary outcome measure)
  • This is a proof-of-concept study. The primary endpoints are: ADAS-Cog [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • EXIT-25 [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • ADCS-ADL [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • This is a proof-of-concept study. The primary endpoints are: ADAS-Cog [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • EXIT-25 [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
  • ADCS-ADL [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01027858 on ClinicalTrials.gov Archive Site
  • Secondary outcomes of interest include: performance of specific executive processes [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Physical function [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Inflammatory biomarkers [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Serum glucose and lipids. These will be assessed at 6 and 12 months. [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Secondary outcomes of interest include: performance of specific executive processes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Physical function [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
  • Inflammatory biomarkers [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
  • Serum glucose and lipids. These will be assessed at 6 and 12 months. [ Time Frame: 6 to 12 months ] [ Designated as safety issue: No ]
  • Brain Structure [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Volume and white matter lesions.
  • Brain Function [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
    fMRI and resting state
Not Provided
 
PROMOTE: Promotion of the Mind Through Exercise
Role of Exercise on Cognition and Function in Seniors With Vascular Cognitive Impairment: A Randomized Controlled Trial

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Vascular Cognitive Impairment
  • Behavioral: Aerobic-based exercise training
    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).
  • Behavioral: CON (control; usual care)
    Nutrition education and usual care as prescribed by neurologist
  • Experimental: 1
    AT (aerobic-based exercise training)
    Intervention: Behavioral: Aerobic-based exercise training
  • Active Comparator: 2
    CON (control; usual care)
    Intervention: Behavioral: CON (control; usual care)
Liu-Ambrose T, Eng JJ, Boyd LA, Jacova C, Davis JC, Bryan S, Lee P, Brasher P, Hsiung GY. Promotion of the mind through exercise (PROMoTE): a proof-of-concept randomized controlled trial of aerobic exercise training in older adults with vascular cognitive impairment. BMC Neurol. 2010 Feb 17;10:14. doi: 10.1186/1471-2377-10-14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
March 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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:

  1. Dysexecutive Syndrome: Some impairment in goal formulation, initiation, planning, organizing, sequencing, executing, set-shifting and maintenance, or abstracting.
  2. Memory Deficit: Some impairment in recall, relative intact recognition, less severe forgetting, benefit from cues.
  3. Progression: Deterioration of A1 and A2 from a previous higher level of functioning that are not per se interfering with complex occupational and social activities.

B. Small Vessel Ischaemic Disease defined as:

  1. 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).

  2. Presence or a history of neurological signs as evidence for cerebrovascular disease such as hemiparesis, lower facial weakness, Babinski sign, sensory deficit, dysarthria, gait disorder, extrapyramidal signs consistent with sub-cortical brain lesion(s).

In addition, individuals must meet the following inclusion criteria:

  1. Montreal Cognitive Assessment (MoCA) (4) score less than 26 at screening;
  2. MMSE (5) score of > 20 at screening;
  3. Community-dwelling;
  4. Lives in Metro Vancouver;
  5. Have a caregiver, family member, or friend who interacts with him/her on a weekly basis;
  6. Able to comply with scheduled visits, treatment plan, and other trial procedures;
  7. Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity;
  8. 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;
  9. 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;
  10. Able to walk independently; and
  11. 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. 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);
  4. Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
  5. 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
  6. Individual who plans to participate or is enrolled in a clinical drug trial concurrent to this study.
Both
45 Years and older
No
Contact: Michelle Munkacsy, MHK 604 875 4111 ext 69056
Canada
 
NCT01027858
H09-00529
Yes
University of British Columbia
University of British Columbia
  • Canadian Stroke Network
  • Heart and Stroke Foundation of Canada
Principal Investigator: Teresa Liu-Ambrose, Ph.D, PT University of British Columbia
Study Director: Janice Eng, Ph.D University of British Columbia
Study Director: Lara Boyd, Ph.D University of British Columbia
Study Director: Robin Hsiung, Ph.D University of British Columbia
Study Director: Claudia Jacova, Ph.D University of British Columbia
Study Director: Howard Feldman, MD University of British Columbia
Study Director: Penny Brasher, Ph.D University of British Columbia
Study Director: Philip Lee, Ph.D University of British Columbia
University of British Columbia
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP