Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke
Vitality
Complex Mental and Social Activities to Promote Cognitive Function in Older Adults With Chronic Stroke: A Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief Summary
The investigators will conduct a randomized controlled trial study to provide preliminary evidence of efficacy of exercise training or a complex mental and social activities program for improving cognitive function in older adults with chronic stroke, compared with a stretch and relaxation program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Nov 2013
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2013
CompletedFirst Posted
Study publicly available on registry
August 5, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedAugust 28, 2020
August 1, 2020
5.8 years
July 23, 2013
August 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months
ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog 13, higher scores indicate greater impairment.
Baseline and 6 months
Secondary Outcomes (24)
Change from baseline in executive functions as measured by the Stroop Test.
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in executive functions as measured by the Tower of London Test.
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in processing speed and executive functions as measured by the Trail Making Tests (Parts A & B).
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in category fluency.
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in memory and executive functions as measured by the verbal digits forward and backward tests.
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
- +19 more secondary outcomes
Study Arms (3)
Exercise training
EXPERIMENTALTwice-weekly for the 6-month duration.
Complex mental and social activities
EXPERIMENTALTwice-weekly for the 6-month duration.
Control: stretching and relaxation program
ACTIVE COMPARATORTwice-weekly for the 6-month duration.
Interventions
The EX Program will provide objective progression in the guided exercises of each participant.
The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.
The CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position.
Eligibility Criteria
You may qualify if:
- Aged 55 years or over;
- Have a history of a single stroke of at least one year prior to study enrolment;
- Mini-Mental State Examination (MMSE) (5) score of ≥ 20 at screening, including a perfect score on the 3-step command to ensure intact comprehension and ability to follow instructions;
- Have subjective cognitive complaints;
- 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;
- Able to walk for a minimum of six metres with rest intervals with or without assistive devices;
- Have an activity tolerance of 60 minutes with rest intervals;
- Not currently participating in any regular therapy or progressive exercise; and
- 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.
You may not qualify if:
- Diagnosed with dementia of any type;
- Diagnosed with another type of neurodegenerative or neurological condition (ie. Parkinson's disease) that affects cognitive function 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, as determined by his/her family physician;
- 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
- Have aphasia as judged by an inability to communicate by phone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of British Columbia
Vancouver, British Columbia, Canada
Related Publications (3)
Liu-Ambrose T, Falck RS, Dao E, Best JR, Davis JC, Bennett K, Hall PA, Hsiung GR, Middleton LE, Goldsmith CH, Graf P, Eng JJ. Effect of Exercise Training or Complex Mental and Social Activities on Cognitive Function in Adults With Chronic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2236510. doi: 10.1001/jamanetworkopen.2022.36510.
PMID: 36227593DERIVEDFalck RS, Best JR, Davis JC, Eng JJ, Middleton LE, Hall PA, Liu-Ambrose T. Sleep and cognitive function in chronic stroke: a comparative cross-sectional study. Sleep. 2019 May 1;42(5):zsz040. doi: 10.1093/sleep/zsz040.
PMID: 30805652DERIVEDBest JR, Eng JJ, Davis JC, Hsiung R, Hall PA, Middleton LE, Graf P, Goldsmith CH, Liu-Ambrose T. Study protocol for Vitality: a proof-of-concept randomised controlled trial of exercise training or complex mental and social activities to promote cognition in adults with chronic stroke. BMJ Open. 2018 Mar 17;8(3):e021490. doi: 10.1136/bmjopen-2018-021490.
PMID: 29550783DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janice J Eng, PhD, PT
University of British Columbia
- PRINCIPAL INVESTIGATOR
Teresa Liu-Ambrose, PhD, PT
University of British Columbia
- PRINCIPAL INVESTIGATOR
Peter Hall, PhD
University of Waterloo
- PRINCIPAL INVESTIGATOR
Charlie Goldsmith, PhD
Simon Fraser University
- PRINCIPAL INVESTIGATOR
Jennifer Davis, PhD
University of British Columbia
- PRINCIPAL INVESTIGATOR
Laura Middleton, PhD
University of Waterloo
- PRINCIPAL INVESTIGATOR
Ging-Yuek Robin Hsiung, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 23, 2013
First Posted
August 5, 2013
Study Start
November 1, 2013
Primary Completion
August 1, 2019
Study Completion
February 1, 2020
Last Updated
August 28, 2020
Record last verified: 2020-08