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

August 26, 2020 updated by: Teresa Liu-Ambrose, University of British Columbia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Baseline and 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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.
Time Frame: Baseline, 3 months, 6 months, and 12 months
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).
Time Frame: Baseline, 3 months, 6 months, and 12 months
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).
Time Frame: Baseline, 3 months, 6 months, and 12 months
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.
Time Frame: Baseline, 3 months, 6 months, and 12 months
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.
Time Frame: Baseline, 3 months, 6 months, and 12 months
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
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
Baseline, 3 months, 6 months, and 12 months
Change from baseline in quadriceps strength.
Time Frame: Baseline, 3 months, 6 months, and 12 months
Baseline, 3 months, 6 months, and 12 months
Change from baseline in grip strength.
Time Frame: Baseline, 3 months, 6 months, and 12 months
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
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).
Time Frame: Baseline, 3 months, 6 months, and 12 months
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).
Time Frame: Baseline, 3 months, 6 months, and 12 months
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
Time Frame: Baseline, 3 months, 6 months, and 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.
Time Frame: Baseline, 3 months, 6 months, and 12 months
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
Baseline, 3 months, 6 months, and 12 months
Change from Baseline in lipid profile.
Time Frame: Baseline and 6 months
Baseline and 6 months
Change from Baseline in insulin sensitivity.
Time Frame: Baseline and 6 months
Baseline and 6 months
Health care resource usage.
Time Frame: Baseline, 3, and 6 months
Baseline, 3, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H13-00715

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Exercise training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings