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Comprehensive Cardiovascular Rehabilitation Feasibility After Stroke (CCR FAST) will evaluate the feasibility of enrolling Regions Hospital stroke patients in a Comprehensive Cardiovascular Rehabilitation (CCR) program. CCR will include aerobic exercise and patient education (regarding risk factors and medication compliance), similar to the rehabilitation program for cardiac disease patients. The overall goal of CCR FAST is to demonstrate the feasibility and safety of including stroke patients in a CCR program, while examining the clinical value in reducing stroke recurrence, myocardial infarction, readmission, and mortality in stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Exercise intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 36 sessions of comprehensive cardiac rehabilitation over 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attendance Rate | 75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With or Without Recurrent Stroke | Recurrent stroke in follow-up period | 6 month |
| Number of Participants With or Without Myocardial Infarction | Myocardial infarction in follow-up time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haitham M Hussein, MD | Regions Hospital Stroke Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States | ||
| Regions Hospital Outpatient Cardiopulmonary Rehabilitation Clinic |
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32 patients assessed for eligibility
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Exercise intervention Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
14 Enrolled and consented stroke patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Exercise intervention Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks |
| 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 | Attendance Rate | 75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions | 14 Stroke patients who enrolled and consented in study | Posted | Count of Participants | Participants | 12 weeks |
|
|
6 months
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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 | Intervention | Stroke patients enrolled in study | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Herrmann, PhD | HealthPartners Neuroscience Research | 651-495-6356 | amanda.a.herrmann@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2020 | Jan 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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single arm, non-randomized
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| 6 month |
| Hospital Readmission | rate, for a cardiovascular or cerebrovascular indication | 6 month |
| Number of Participants With or Without Silent Stroke | rate, on MRI | 6 month |
| Number of Participants Without Death | rate | 6 month |
| Saint Paul |
| Minnesota |
| 55114 |
| United States |
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking Status | Count of Participants | Participants |
|
| Stroke Mechanism | Count of Participants | Participants |
|
| National Institutes of Health Stroke Scale (NIHSS) | NIHSS is a tool used to evaluate stroke severity. The total score ranges from 0-42, with a higher score indicating a more severe stroke. | Median | Inter-Quartile Range | units on a scale |
|
| Length of Stay for Initial Stroke Admission | Mean | Standard Deviation | days |
|
| Weight | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | lbs |
|
| Body Mass Index (BMI) | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | kg/m^2 |
|
| Systolic Blood Pressure (SBP) | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure (DBP) | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mmHg |
|
| Triglycerides | Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab | Mean | Standard Deviation | mg/dL |
|
| HDL | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mg/dL |
|
| LDL | Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab | Mean | Standard Deviation | mg/dL |
|
| Non-HDL | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mg/dL |
|
| Sodium | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mEq/L |
|
| Potassium | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mEq/L |
|
| Chloride | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mEq/L |
|
| Bicarbonate (cO2) | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mEq/L |
|
| Glucose | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mg/dL |
|
| Creatinine | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mg/dL |
|
| Calcium | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mg/dL |
|
| Anion Gap | Only patients who began CCR Fast exercise program and had baseline physical visit | Mean | Standard Deviation | mEq/L |
|
| International Normalized Rate (INR) | Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab | Mean | Standard Deviation | ratio |
|
| Prothrombin Time (PT) | Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab | Mean | Standard Deviation | seconds |
|
| A1c | Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab | Mean | Standard Deviation | mg/dL |
|
| Glomerular Filtration Rate | Only patients who began CCR Fast exercise program and had baseline physical visit | Count of Participants | Participants |
|
|
| Secondary | Number of Patients With or Without Recurrent Stroke | Recurrent stroke in follow-up period | 14 Stroke patients who enrolled and consented in study | Posted | Count of Participants | Participants | 6 month |
|
|
|
| Secondary | Number of Participants With or Without Myocardial Infarction | Myocardial infarction in follow-up time | 14 Stroke patients who enrolled and consented in study | Posted | Count of Participants | Participants | 6 month |
|
|
|
| Secondary | Hospital Readmission | rate, for a cardiovascular or cerebrovascular indication | 14 Stroke patients who enrolled and consented in study | Posted | Count of Participants | Participants | 6 month |
|
|
|
| Secondary | Number of Participants With or Without Silent Stroke | rate, on MRI | 14 Stroke patients who enrolled and consented in study | Posted | Count of Participants | Participants | 6 month |
|
|
|
| Secondary | Number of Participants Without Death | rate | 14 Stroke patients who enrolled and consented in study | Posted | Count of Participants | Participants | 6 month |
|
|
|
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |