PROMOTE: Promotion of the Mind Through Exercise

NCT01027858 | Completed DMC

• 1 other identifier: H09-00529
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Cognitive Impairment

Keywords

exercise; aerobic exercise training; vascular cognitive impairment; Mild Sub-cortical Ischaemic Vascular Cognitive Impairment (SIVCI)

Outcome Measures

Primary Outcomes (3)

• This is a proof-of-concept study. The primary endpoints are: ADAS-Cog

  baseline, 6 months, and 12 months

• EXIT-25

  baseline, 6 months, and 12 months

• ADCS-ADL

  baseline, 6 months, and 12 months

Secondary Outcomes (4)

• Secondary outcomes of interest include: performance of specific executive processes

  baseline, 6 months, and 12 months

• Physical function

  baseline, 6 months, and 12 months

• Inflammatory biomarkers

  baseline, 6 months, and 12 months

• Serum glucose and lipids. These will be assessed at 6 and 12 months.

  baseline, 6 months, and 12 months

Other Outcomes (2)

• Brain Structure

  Baseline and 6 months

• Brain Function

  Baseline and 6 months

Study Arms (2)

1

EXPERIMENTAL

AT (aerobic-based exercise training)

Behavioral: Aerobic-based exercise training

2

ACTIVE COMPARATOR

CON (control; usual care)

Behavioral: CON (control; usual care)

Interventions

Aerobic-based exercise training BEHAVIORAL

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).

1

CON (control; usual care) BEHAVIORAL

Nutrition education and usual care as prescribed by neurologist

2

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Dysexecutive Syndrome: Some impairment in goal formulation, initiation, planning, organizing, sequencing, executing, set-shifting and maintenance, or abstracting.
• Memory Deficit: Some impairment in recall, relative intact recognition, less severe forgetting, benefit from cues.
• 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:
• 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).
• 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).
• Montreal Cognitive Assessment (MoCA) (4) score less than 26 at screening;
• MMSE (5) score of \> 20 at screening;
• Community-dwelling;
• Lives in Metro Vancouver;
• Have a caregiver, family member, or friend who interacts with him/her on a weekly basis;
• Able to comply with scheduled visits, treatment plan, and other trial procedures;

You may not qualify if:

• 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;
• 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);
• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Stroke Network: collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

Related Publications (13)

• Liu-Ambrose T, Best JR, Davis JC, Eng JJ, Lee PE, Jacova C, Boyd LA, Brasher PM, Munkacsy M, Cheung W, Hsiung GR. Aerobic exercise and vascular cognitive impairment: A randomized controlled trial. Neurology. 2016 Nov 15;87(20):2082-2090. doi: 10.1212/WNL.0000000000003332. Epub 2016 Oct 19.

  PMID: 27760869 BACKGROUND

• 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.

  PMID: 20158920 BACKGROUND

• Hsu CL, Best JR, Davis JC, Nagamatsu LS, Wang S, Boyd LA, Hsiung GR, Voss MW, Eng JJ, Liu-Ambrose T. Aerobic exercise promotes executive functions and impacts functional neural activity among older adults with vascular cognitive impairment. Br J Sports Med. 2018 Feb;52(3):184-191. doi: 10.1136/bjsports-2016-096846. Epub 2017 Apr 21.

  PMID: 28432077 BACKGROUND

• Barha CK, Hsiung GR, Best JR, Davis JC, Eng JJ, Jacova C, Lee PE, Munkacsy M, Cheung W, Liu-Ambrose T. Sex Difference in Aerobic Exercise Efficacy to Improve Cognition in Older Adults with Vascular Cognitive Impairment: Secondary Analysis of a Randomized Controlled Trial. J Alzheimers Dis. 2017;60(4):1397-1410. doi: 10.3233/JAD-170221.

  PMID: 29036816 BACKGROUND

• Dao E, Barha CK, Best JR, Hsiung GY, Tam R, Liu-Ambrose T. The Effect of Aerobic Exercise on White Matter Hyperintensity Progression May Vary by Sex. Can J Aging. 2019 Jun;38(2):236-244. doi: 10.1017/S0714980818000582. Epub 2019 Mar 14.

  PMID: 30867079 BACKGROUND

• A history of the Arkansas State Dental Hygienists Association. Ark Dent J. 1987 Apr;58(1):43. No abstract available.

  PMID: 3107531 BACKGROUND

• Barha CK, Dao E, Marcotte L, Hsiung GR, Tam R, Liu-Ambrose T. Cardiovascular risk moderates the effect of aerobic exercise on executive functions in older adults with subcortical ischemic vascular cognitive impairment. Sci Rep. 2021 Oct 7;11(1):19974. doi: 10.1038/s41598-021-99249-1.

  PMID: 34620933 BACKGROUND

• Barha CK, Starkey SY, Hsiung GYR, Tam R, Liu-Ambrose T. Aerobic exercise improves executive functions in females, but not males, without the BDNF Val66Met polymorphism. Biol Sex Differ. 2023 Apr 3;14(1):16. doi: 10.1186/s13293-023-00499-7.

  PMID: 37013586 DERIVED

• Barha CK, Hsiung GYR, Liu-Ambrose T. The Role of S100B in Aerobic Training Efficacy in Older Adults with Mild Vascular Cognitive Impairment: Secondary Analysis of a Randomized Controlled Trial. Neuroscience. 2019 Jul 1;410:176-182. doi: 10.1016/j.neuroscience.2019.04.052. Epub 2019 May 7.

  PMID: 31075314 DERIVED

• Dao E, Best JR, Hsiung GR, Sossi V, Jacova C, Tam R, Liu-Ambrose T. Associations between cerebral amyloid and changes in cognitive function and falls risk in subcortical ischemic vascular cognitive impairment. BMC Geriatr. 2017 Jun 28;17(1):133. doi: 10.1186/s12877-017-0522-4.

  PMID: 28659161 DERIVED

• Davis JC, Hsiung GR, Bryan S, Best JR, Eng JJ, Munkacsy M, Cheung W, Chiu B, Jacova C, Lee P, Liu-Ambrose T. Economic evaluation of aerobic exercise training in older adults with vascular cognitive impairment: PROMoTE trial. BMJ Open. 2017 Mar 29;7(3):e014387. doi: 10.1136/bmjopen-2016-014387.

  PMID: 28360247 DERIVED

• Davis JC, Hsiung GY, Bryan S, Jacova C, Jacova P, Munkacsy M, Cheung W, Lee P, Liu-Ambrose T. Agreement between Patient and Proxy Assessments of Quality of Life among Older Adults with Vascular Cognitive Impairment Using the EQ-5D-3L and ICECAP-O. PLoS One. 2016 Apr 21;11(4):e0153878. doi: 10.1371/journal.pone.0153878. eCollection 2016.

  PMID: 27101402 DERIVED

• Dao E, Hsiung GY, Sossi V, Jacova C, Tam R, Dinelle K, Best JR, Liu-Ambrose T. Exploring the effects of coexisting amyloid in subcortical vascular cognitive impairment. BMC Neurol. 2015 Oct 12;15:197. doi: 10.1186/s12883-015-0459-1.

  PMID: 26459220 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Teresa Liu-Ambrose, Ph.D, PT

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

CA (1)