Transient Ischemic Attack
Conditions
Keywords
cardiac rehab
Brief summary
It is hypothesized that the addition of formal cardiac rehabilitation to standard care will result in long-term improvements in cardiovascular fitness and functional capacity in individuals who have suffered a transient ischemic attack (TIA) or minor stroke. Furthermore, it is proposed that the addition of cardiac rehabilitation will influence depressive symptoms and cognition.
Detailed description
A transient ischemic attack (TIA) is defined as an episode of neurological dysfunction caused by focal brain ischemia lasting less than 24 hours. Once an individual has suffered a TIA, preventative measures can be taken to target modifiable risk factors, one of which is physical inactivity. The current proposal focuses on the use of an established model of care (cardiac rehabilitation (CR)) and applies it to those who have suffered a TIA in order to maximize physical activity and minimize risk of future cardiovascular events. This will be a one-group pre/post design study with a 3 month non-intervention period. Participants will undergo measures at baseline and 3 months (non intervention period) then after 6 months of cardiac rehabilitation (cardiovascular fitness, 6 minute walk test, cognition, and depressive symptoms).
Interventions
BEHAVIORALCardiac Rehabilitation
Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Sponsors
Heart and Stroke Foundation of Canada
Toronto Rehabilitation Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with TIA * Three months post-TIA * Ability to understand the process and instructions for exercise training and provide informed consent
Exclusion criteria
* Resting Blood Pressure greater than 160/100 despite medication * Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal BP responses or STsegment depression \> 2 mm, symptomatic aortic stenosis, complex arrhythmias) * Current and extensive exercise participation * Hypertrophic Cardiomyopathy * Unstable Angina * Orthostatic BP decrease of \> 20 mm Hg with symptoms * Other musculoskeletal impairments which would limit the participants ability to walk sufficient durations * Pain or other co-morbidities (e.g., unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation * Cognitive or behavioural issues that would limit participation in exercise testing and training
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Walk Test | Baseline, 3 months, 6 months (Six Minute Walk Distance) | 6 minute walk test: the longest distance a person can walk for a duration of 6 minutes |
| Cardiovascular Fitness (VO2peak) | Baseline (after the 3 month non-intervention period) and after 6 months of participation. | To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiologic Studies Depression Scale (CES-D). | Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation | Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D). This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse). |
| Cognition | Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation | Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.
Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training. | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | employment | 1 |
| Overall Study | medical issue unrelated to intervention | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Exercise |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment Canada | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Cardiovascular Fitness (VO2peak)
To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.
Time frame: Baseline (after the 3 month non-intervention period) and after 6 months of participation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | Cardiovascular Fitness (VO2peak) | Baseline | 16.7 ml/kg/min | Standard Deviation 5 |
| Exercise | Cardiovascular Fitness (VO2peak) | 6 months | 19.1 ml/kg/min | Standard Deviation 4.6 |
p-value: 0.01t-test, 2 sided
Primary
Functional Walk Test
6 minute walk test: the longest distance a person can walk for a duration of 6 minutes
Time frame: Baseline, 3 months, 6 months (Six Minute Walk Distance)
Population: Transient Ischemic Attack participants who completed the 6 month intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | Functional Walk Test | Baseline | 498.4 meters | Standard Deviation 95.2 |
| Exercise | Functional Walk Test | 3 months | 503.2 meters | Standard Deviation 111.1 |
| Exercise | Functional Walk Test | 6 months | 564.2 meters | Standard Deviation 139.6 |
Comparison: With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.p-value: =0.06ANOVA
p-value: 0.06t-test, 2 sided
Secondary
Center for Epidemiologic Studies Depression Scale (CES-D).
Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D). This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse).
Time frame: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
Population: Transient Ischemic Attack. Two patients did not complete questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | Center for Epidemiologic Studies Depression Scale (CES-D). | Baseline | 6.5 score on a scale | Standard Deviation 6 |
| Exercise | Center for Epidemiologic Studies Depression Scale (CES-D). | 3 months | 7.6 score on a scale | Standard Deviation 5 |
| Exercise | Center for Epidemiologic Studies Depression Scale (CES-D). | 6 months | 4.3 score on a scale | Standard Deviation 5.2 |
Comparison: With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.p-value: 0.04ANOVA
Secondary
Cognition
Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.
Time frame: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
Population: TIA. Three subjects did not complete the assessment at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise | Cognition | Baseline | 26.5 units on a scale | Standard Deviation 2.4 |
| Exercise | Cognition | 3 months | 26.8 units on a scale | Standard Deviation 3.4 |
| Exercise | Cognition | 6 months | 27.1 units on a scale | Standard Deviation 2 |
Comparison: With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.p-value: >0.05ANOVA