StrokeVitalityNCT01916486
Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke
A study testing Exercise training and Complex mental and social activities in people with Stroke and Chronic Stroke, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Stroke, Chronic Stroke
- What is being tested?
- Exercise training and Complex mental and social activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Chronic Stroke
- Being tested
- Exercise training, Complex mental and social activities, Control: stretching and relaxation program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
Also called EX Program
The EX Program will provide objective progression in the guided exercises of each participant.
Complex mental and social activitiesBehavioural
Also called Cog-Plus Program
The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.
Control: stretching and relaxation programBehavioural
Also called CON Program
The CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | Twice-weekly for the 6-month duration. Receives: Behavioral: Exercise training |
| Complex mental and social activities | Experimental | Twice-weekly for the 6-month duration. Receives: Behavioral: Complex mental and social activities |
| Control: stretching and relaxation program | Active comparator | Twice-weekly for the 6-month duration. Receives: Behavioral: Control: stretching and relaxation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (24)
Change from baseline in executive functions as measured by the Stroop Test.
Measured: 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.
Measured: 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).
Measured: Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in category fluency.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from baseline in general balance and mobility as measured by the Short Physical Performance Battery.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from baseline in functional capacity as measured by the 6 Minute Walk Test.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from baseline in general balance and mobility as measured the Timed Up-and-Go Test.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from baseline in quadriceps strength.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from baseline in grip strength.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Pittsburgh Sleep Index.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Motion Watch 8.
Measured: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in lipid profile.
Measured: Baseline and 6 months
Change from Baseline in insulin sensitivity.
Measured: Baseline and 6 months
Health care resource usage.
Measured: Baseline, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2019
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Teresa Liu-Ambrose, University of British Columbia
- Investigators
- Janice J Eng, PhD, PT, Principal investigator, University of British ColumbiaTeresa Liu-Ambrose, PhD, PT, Principal investigator, University of British ColumbiaPeter Hall, PhD, Principal investigator, University of WaterlooCharlie Goldsmith, PhD, Principal investigator, Simon Fraser UniversityJennifer Davis, PhD, Principal investigator, University of British ColumbiaLaura Middleton, PhD, Principal investigator, University of WaterlooGing-Yuek Robin Hsiung, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916486
- Sponsor's protocol ID
- H13-00715
- Acronym
- Vitality
- Status last verified
- Aug 2020
- First submitted
- 23 Jul 2013
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 36227593Falck 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.
PubMed 30805652Best 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.
PubMed 29550783
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Mental and Social Activities to Promote Cognitive Function in Older Adults With Chronic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01916486
- Acronym / sponsor ID
- Vitality / H13-00715
- Conditions
- Stroke, Chronic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2013
- Primary completion
- Aug 2019 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Exercise trainingTwice-weekly for the 6-month duration. |
| Complex mental and social activities | Experimental | Behavioral: Complex mental and social activitiesTwice-weekly for the 6-month duration. |
| Control: stretching and relaxation program | Active comparator | Behavioral: Control: stretching and relaxation programTwice-weekly for the 6-month duration. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingAlso: EX ProgramThe EX Program will provide objective progression in the guided exercises of each participant. | Behavioural | Exercise training |
| Complex mental and social activitiesAlso: Cog-Plus ProgramThe Cog-Plus Program will engage participants in activities promoting cognitive function and socialization. | Behavioural | Complex mental and social activities |
| Control: stretching and relaxation programAlso: CON ProgramThe CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position. | Behavioural | Control: stretching and relaxation program |
Primary outcome
Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months
Time frame: Baseline and 6 months
ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog 13, higher scores indicate greater impairment.
24 secondary outcomes
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
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
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
Change from baseline in category fluency.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in fatigue as measured by the Fatigue Severity Scale.
Time frame: 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).
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in community mobility as measured by the Life-space Assessment (LSA).
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in leisure activity as measured by the Shortened Nottingham Leisure Scale.
Time frame: Baseline, 3 months, 6 months, and 12 months
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
Change from baseline in functional capacity as measured by the 6 Minute Walk Test.
Time frame: Baseline, 3 months, 6 months, and 12 months
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
Change from baseline in quadriceps strength.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in grip strength.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in mood as measured by the Center for Epidemiologic Studies Depression Scale.
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Pittsburgh Sleep Index.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Motion Watch 8.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in lipid profile.
Time frame: Baseline and 6 months
Change from Baseline in insulin sensitivity.
Time frame: Baseline and 6 months
Health care resource usage.
Time frame: Baseline, 3, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Derived from this study: PubMed 36227593Liu-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.
- Derived from this study: PubMed 30805652Falck 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.
- Derived from this study: PubMed 29550783Best 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice J Eng, PhD, PT principal investigator
University of British Columbia
Teresa Liu-Ambrose, PhD, PT principal investigator
University of British Columbia
Peter Hall, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training and Complex mental and social activities in people with Stroke and Chronic Stroke, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916486, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.