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Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke

University of British Columbia logo

University of British Columbia

Status

Completed

Conditions

Stroke
Chronic Stroke

Treatments

Behavioral: Complex mental and social activities
Behavioral: Exercise training
Behavioral: Control: stretching and relaxation program

Study type

Interventional

Funder types

Other

Identifiers

NCT01916486
H13-00715

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

  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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 3 patient groups

Exercise training
Experimental group
Description:
Twice-weekly for the 6-month duration.
Treatment:
Behavioral: Exercise training
Complex mental and social activities
Experimental group
Description:
Twice-weekly for the 6-month duration.
Treatment:
Behavioral: Complex mental and social activities
Control: stretching and relaxation program
Active Comparator group
Description:
Twice-weekly for the 6-month duration.
Treatment:
Behavioral: Control: stretching and relaxation program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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