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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Following a 3 month non intervention period, participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Rehabilitation | Behavioral | Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Walk Test | 6 minute walk test: the longest distance a person can walk for a duration of 6 minutes | Baseline, 3 months, 6 months (Six Minute Walk Distance) |
| 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. | Baseline (after the 3 month non-intervention period) and after 6 months of participation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation |
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Inclusion Criteria:
Exclusion Criteria:
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TIA
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| Name | Affiliation | Role |
|---|---|---|
| Dina Brooks, PhD | Toronto Rehabilitation Institute | Principal Investigator |
| William E McIllroy, PhD | University of Waterloo | Principal Investigator |
| Paul Oh, MD | Toronto Rehabilitation Institute | Principal Investigator |
| Sandra Black, MD | Sunnybrook and Women's College Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Rehabilitation Institute - Rumsey Center | Toronto | Ontario | M4G 1R7 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding the exercise program. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Functional Walk Test | 6 minute walk test: the longest distance a person can walk for a duration of 6 minutes | Transient Ischemic Attack participants who completed the 6 month intervention. | Posted | Mean | Standard Deviation | meters | Baseline, 3 months, 6 months (Six Minute Walk Distance) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise | Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding cardiac rehabilitation. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training. |
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This study was conducted in a single centre located in a large city centre and may lack generalizability to other programs, including those where CR services are not publicly funded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. | Toronto Rehab | 4169781739 | dina.brooks@utoronto.ca |
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| ID | Term |
|---|---|
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Cognition | Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function. | Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | ml/kg/min | Baseline (after the 3 month non-intervention period) and after 6 months of participation. |
|
|
|
|
| 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). | Transient Ischemic Attack. Two patients did not complete questionnaires. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation |
|
|
|
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| Secondary | Cognition | Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function. | TIA. Three subjects did not complete the assessment at each time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation |
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| 0 |
| 20 |
| 0 |
| 20 |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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