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Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke (Vitality)

Primary Purpose

Stroke, Chronic Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise training
Complex mental and social activities
Control: stretching and relaxation program
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Exercise training

Complex mental and social activities

Control: stretching and relaxation program

Arm Description

Twice-weekly for the 6-month duration.

Twice-weekly for the 6-month duration.

Twice-weekly for the 6-month duration.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline in executive functions as measured by the Stroop Test.
Change from baseline in executive functions as measured by the Tower of London Test.
Change from baseline in processing speed and executive functions as measured by the Trail Making Tests (Parts A & B).
Change from baseline in category fluency.
Change from baseline in memory and executive functions as measured by the verbal digits forward and backward tests.
Change from baseline in instrumental activities of daily living as measured by the Instrumental Activities of Daily Living Scale.
Higher scores indicate better performance.
Change from baseline in fatigue as measured by the Fatigue Severity Scale.
Higher scores indicate greater fatigue.
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.
Change from baseline in community mobility as measured by the Life-space Assessment (LSA).
Higher scores indicate greater community mobility.
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.
Change from baseline in general balance and mobility as measured by the Short Physical Performance Battery.
Change from baseline in functional capacity as measured by the 6 Minute Walk Test.
Change from baseline in general balance and mobility as measured the Timed Up-and-Go Test.
Change from baseline in quadriceps strength.
Change from baseline in grip strength.
Change from baseline in mood as measured by the Center for Epidemiologic Studies Depression Scale.
Higher scores indicate greater impairment in mood.
Change from baseline in quality of life as measured by the European Quality of Life-5 Dimensions (EQ-5D).
Acquired on a monthly basis.
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.
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.
Change from Baseline in sleep quality as measured by the Pittsburgh Sleep Index.
Change from Baseline in sleep quality as measured by the Motion Watch 8.
Change from Baseline in lipid profile.
Change from Baseline in insulin sensitivity.
Health care resource usage.

Full Information

First Posted
July 23, 2013
Last Updated
August 26, 2020
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01916486
Brief Title
Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke
Acronym
Vitality
Official Title
Complex Mental and Social Activities to Promote Cognitive Function in Older Adults With Chronic Stroke: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Chronic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise training
Arm Type
Experimental
Arm Description
Twice-weekly for the 6-month duration.
Arm Title
Complex mental and social activities
Arm Type
Experimental
Arm Description
Twice-weekly for the 6-month duration.
Arm Title
Control: stretching and relaxation program
Arm Type
Active Comparator
Arm Description
Twice-weekly for the 6-month duration.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Other Intervention Name(s)
EX Program
Intervention Description
The EX Program will provide objective progression in the guided exercises of each participant.
Intervention Type
Behavioral
Intervention Name(s)
Complex mental and social activities
Other Intervention Name(s)
Cog-Plus Program
Intervention Description
The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.
Intervention Type
Behavioral
Intervention Name(s)
Control: stretching and relaxation program
Other Intervention Name(s)
CON Program
Intervention Description
The CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position.
Primary Outcome Measure Information:
Title
Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months
Description
ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog 13, higher scores indicate greater impairment.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in executive functions as measured by the Stroop Test.
Time Frame
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Title
Change from baseline in executive functions as measured by the Tower of London Test.
Time Frame
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Title
Change from baseline in processing speed and executive functions as measured by the Trail Making Tests (Parts A & B).
Time Frame
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Title
Change from baseline in category fluency.
Time Frame
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Title
Change from baseline in memory and executive functions as measured by the verbal digits forward and backward tests.
Time Frame
Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Title
Change from baseline in instrumental activities of daily living as measured by the Instrumental Activities of Daily Living Scale.
Description
Higher scores indicate better performance.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in fatigue as measured by the Fatigue Severity Scale.
Description
Higher scores indicate greater fatigue.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in physical activity level as measured by the Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS).
Description
Acquired on a monthly basis. Higher scores indicate greater activity.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in community mobility as measured by the Life-space Assessment (LSA).
Description
Higher scores indicate greater community mobility.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in leisure activity as measured by the Shortened Nottingham Leisure Scale.
Description
Acquired on a monthly basis. Higher scores indicate greater leisure activity.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in general balance and mobility as measured by the Short Physical Performance Battery.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in functional capacity as measured by the 6 Minute Walk Test.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in general balance and mobility as measured the Timed Up-and-Go Test.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in quadriceps strength.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in grip strength.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in mood as measured by the Center for Epidemiologic Studies Depression Scale.
Description
Higher scores indicate greater impairment in mood.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in quality of life as measured by the European Quality of Life-5 Dimensions (EQ-5D).
Description
Acquired on a monthly basis.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from baseline in quality of life as measured by European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS).
Description
Acquired on a monthly basis.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from Baseline in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Cog Plus) at 12 months
Description
ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog Plus, higher scores indicate greater impairment.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from Baseline in sleep quality as measured by the Pittsburgh Sleep Index.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from Baseline in sleep quality as measured by the Motion Watch 8.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Change from Baseline in lipid profile.
Time Frame
Baseline and 6 months
Title
Change from Baseline in insulin sensitivity.
Time Frame
Baseline and 6 months
Title
Health care resource usage.
Time Frame
Baseline, 3, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice J Eng, PhD, PT
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teresa Liu-Ambrose, PhD, PT
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Hall, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charlie Goldsmith, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Davis, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Middleton, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ging-Yuek Robin Hsiung, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36227593
Citation
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.
Results Reference
derived
PubMed Identifier
30805652
Citation
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.
Results Reference
derived
PubMed Identifier
29550783
Citation
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.
Results Reference
derived

Learn more about this trial

Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke

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