PROMOTE: Promotion of the Mind Through Exercise

February 8, 2022 updated by: Teresa Liu-Ambrose, University of British Columbia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
CON (control; usual care)
Behavioral: CON (control; usual care)
Nutrition education and usual care as prescribed by neurologist
Experimental: 1
AT (aerobic-based exercise training)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
This is a proof-of-concept study. The primary endpoints are: ADAS-Cog
Time Frame: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
EXIT-25
Time Frame: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
ADCS-ADL
Time Frame: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcomes of interest include: performance of specific executive processes
Time Frame: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
Physical function
Time Frame: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
Inflammatory biomarkers
Time Frame: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months
Serum glucose and lipids. These will be assessed at 6 and 12 months.
Time Frame: baseline, 6 months, and 12 months
baseline, 6 months, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain Structure
Time Frame: Baseline and 6 months
Volume and white matter lesions.
Baseline and 6 months
Brain Function
Time Frame: Baseline and 6 months
fMRI and resting state
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Heart and Stroke Foundation of Canada
Canadian Stroke Network

Investigators

  • Study Director: Penny Brasher, Ph.D, University of British Columbia
  • 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: Philip Lee, Ph.D, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 7, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H09-00529

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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