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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Chronic Stroke
• Intervention / Treatment: Behavioral: Exercise training; Behavioral: Complex mental and social activities; Behavioral: Control: stretching and relaxation program

Detailed Description

A total of 119 adults diagnosed with chronic stroke will be randomized to either a 6-month twice-weekly exercise program, complex mental and social activities program, or stretch and relaxation program. After 6 months of intervention, they will be followed for an additional 6 months. There will be four measurement sessions: baseline, 3 months, 6 months (end of intervention period); and 12 months.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

The study will specifically recruit individuals who had an ischemic or hemorrhagic stroke and have probable mild cognitive impairment.

In addition, individuals must meet the following inclusion criteria:

1. Aged 55 years or over;
2. Have a history of a single stroke of at least one year prior to study enrolment;
3. 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;
4. Have subjective cognitive complaints;
5. Community-dwelling;
6. Lives in Metro Vancouver;
7. Able to comply with scheduled visits, treatment plan, and other trial procedures;
8. Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity;
9. 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;
10. Able to walk for a minimum of six metres with rest intervals with or without assistive devices;
11. Have an activity tolerance of 60 minutes with rest intervals;
12. Not currently participating in any regular therapy or progressive exercise; and
13. 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.

Exclusion Criteria:

1. Diagnosed with dementia of any type;
2. Diagnosed with another type of neurodegenerative or neurological condition (ie. Parkinson's disease) that affects cognitive function 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, as determined by his/her family physician;
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. Have aphasia as judged by an inability to communicate by phone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise training; Twice-weekly for the 6-month duration.	Behavioral: Exercise training; The EX Program will provide objective progression in the guided exercises of each participant.; Other Names: EX Program
EXPERIMENTAL: Complex mental and social activities; Twice-weekly for the 6-month duration.	Behavioral: Complex mental and social activities; The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.; Other Names: Cog-Plus Program
ACTIVE_COMPARATOR: Control: stretching and relaxation program; Twice-weekly for the 6-month duration.	Behavioral: Control: stretching and relaxation program; The CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position.; Other Names: CON Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from baseline in instrumental activities of daily living as measured by the Instrumental Activities of Daily Living Scale.	Higher scores indicate better performance.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in fatigue as measured by the Fatigue Severity Scale.	Higher scores indicate greater fatigue.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in physical activity level as measured by the Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS).	Acquired on a monthly basis. Higher scores indicate greater activity.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in community mobility as measured by the Life-space Assessment (LSA).	Higher scores indicate greater community mobility.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in leisure activity as measured by the Shortened Nottingham Leisure Scale.	Acquired on a monthly basis. Higher scores indicate greater leisure activity.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in general balance and mobility as measured by the Short Physical Performance Battery.		Baseline, 3 months, 6 months, and 12 months
Change from baseline in functional capacity as measured by the 6 Minute Walk Test.		Baseline, 3 months, 6 months, and 12 months
Change from baseline in general balance and mobility as measured the Timed Up-and-Go Test.		Baseline, 3 months, 6 months, and 12 months
Change from baseline in quadriceps strength.		Baseline, 3 months, 6 months, and 12 months
Change from baseline in grip strength.		Baseline, 3 months, 6 months, and 12 months
Change from baseline in mood as measured by the Center for Epidemiologic Studies Depression Scale.	Higher scores indicate greater impairment in mood.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in quality of life as measured by the European Quality of Life-5 Dimensions (EQ-5D).	Acquired on a monthly basis.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in quality of life as measured by European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS).	Acquired on a monthly basis.	Baseline, 3 months, 6 months, and 12 months
Change from Baseline in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Cog Plus) at 12 months	ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog Plus, higher scores indicate greater impairment.	Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Pittsburgh Sleep Index.		Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Motion Watch 8.		Baseline, 3 months, 6 months, and 12 months
Change from Baseline in lipid profile.		Baseline and 6 months
Change from Baseline in insulin sensitivity.		Baseline and 6 months
Health care resource usage.		Baseline, 3, and 6 months

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Janice J Eng, PhD, PT, University of British Columbia; Principal Investigator: Peter Hall, PhD, University of Waterloo; Principal Investigator: Laura Middleton, PhD, University of Waterloo; Principal Investigator: Ging-Yuek Robin Hsiung, MD, University of British Columbia

Publications and helpful links

General Publications

• 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.
• Falck 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.
• Best 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (ESTIMATE): August 5, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: H13-00715