Stroke, Ischemic
Conditions
Brief summary
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.
Interventions
BEHAVIORALExercise
36 sessions of comprehensive cardiac rehabilitation over 12 weeks
Sponsors
HealthPartners Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
single arm, non-randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patient has suffered an ischemic stroke * Patient should be ambulatory (non-disabling stroke) to be able to participate in the CCR exercise program * Patient is able to start cardiac rehabilitation within 2 weeks of stroke
Exclusion criteria
* No baseline (index admission for ischemic stroke) MRI completed * Life expectancy \< 1-year * Presence of brain hemorrhage: intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma * Concurrent diagnosis of seizure disorder * Patient with moderate or severe neurologic deficits, limiting their ability to participate in the CCR exercise program * Cardiopulmonary conditions preventing the patient from participation, such as severe heart failure, severe aortic stenosis, and exercise-induced asthma * Patient with cognitive dysfunction impairing their ability to follow directions * Anticipated procedures such as carotid stenting, carotid endarterectomy, and intracranial aneurysm coiling * Patient unable to commit to the frequent visits of the CCR program * Participation in other interventional research (observational research is allowed) * Unable to have brain MRI * Non-English speaker * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance Rate | 12 weeks | 75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With or Without Recurrent Stroke | 6 month | Recurrent stroke in follow-up period |
| Number of Participants With or Without Myocardial Infarction | 6 month | Myocardial infarction in follow-up time |
| Hospital Readmission | 6 month | rate, for a cardiovascular or cerebrovascular indication |
| Number of Participants With or Without Silent Stroke | 6 month | rate, on MRI |
| Number of Participants Without Death | 6 month | rate |
Countries
United States
Participant flow
Recruitment details
32 patients assessed for eligibility * 9 refused to participate * 6 unable to reach
Participants by arm
| Arm | Count |
|---|---|
| Intervention Exercise intervention
Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| A1c | 7.8 mg/dL STANDARD_DEVIATION 3.6 |
| Age, Continuous | 63.3 years STANDARD_DEVIATION 12.4 |
| Anion Gap | 10.4 mEq/L STANDARD_DEVIATION 1.7 |
| Bicarbonate (cO2) | 24.1 mEq/L STANDARD_DEVIATION 3.5 |
| Body Mass Index (BMI) | 35.1 kg/m^2 STANDARD_DEVIATION 8 |
| Calcium | 9.4 mg/dL STANDARD_DEVIATION 0.6 |
| Chloride | 103.9 mEq/L STANDARD_DEVIATION 2.2 |
| Creatinine | 1.0 mg/dL STANDARD_DEVIATION 0.2 |
| Diastolic Blood Pressure (DBP) | 78.9 mmHg STANDARD_DEVIATION 14.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Glomerular Filtration Rate < 60 | 3 Participants |
| Glomerular Filtration Rate > 60 | 7 Participants |
| Glucose | 141.9 mg/dL STANDARD_DEVIATION 82 |
| HDL | 39.6 mg/dL STANDARD_DEVIATION 7.3 |
| International Normalized Rate (INR) | 1.0 ratio STANDARD_DEVIATION 0.1 |
| LDL | 105.7 mg/dL STANDARD_DEVIATION 36.2 |
| Length of Stay for Initial Stroke Admission | 1.8 days STANDARD_DEVIATION 1.1 |
| National Institutes of Health Stroke Scale (NIHSS) | 0.5 units on a scale |
| Non-HDL | 139.1 mg/dL STANDARD_DEVIATION 41.5 |
| Potassium | 4.0 mEq/L STANDARD_DEVIATION 0.3 |
| Prothrombin Time (PT) | 25.9 seconds STANDARD_DEVIATION 6.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 10 Participants |
| Smoking Status Current | 4 Participants |
| Smoking Status Never | 7 Participants |
| Smoking Status Previous | 3 Participants |
| Sodium | 138.1 mEq/L STANDARD_DEVIATION 3.1 |
| Stroke Mechanism Cardiomebolic | 3 Participants |
| Stroke Mechanism Cryptogenic | 3 Participants |
| Stroke Mechanism Lacunar | 2 Participants |
| Stroke Mechanism Large Vessel Extracranial | 4 Participants |
| Stroke Mechanism Other/Missing | 2 Participants |
| Systolic Blood Pressure (SBP) | 136.9 mmHg STANDARD_DEVIATION 17.5 |
| Triglycerides | 188.4 mg/dL STANDARD_DEVIATION 124.1 |
| Weight | 220.2 lbs STANDARD_DEVIATION 34.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Attendance Rate
75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions
Time frame: 12 weeks
Population: 14 Stroke patients who enrolled and consented in study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Attendance Rate | 8 Participants |
Secondary
Hospital Readmission
rate, for a cardiovascular or cerebrovascular indication
Time frame: 6 month
Population: 14 Stroke patients who enrolled and consented in study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Hospital Readmission | No | 8 Participants |
| Intervention | Hospital Readmission | Lost to follow-up | 6 Participants |
Secondary
Number of Participants With or Without Myocardial Infarction
Myocardial infarction in follow-up time
Time frame: 6 month
Population: 14 Stroke patients who enrolled and consented in study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants With or Without Myocardial Infarction | No myocardial infarction | 8 Participants |
| Intervention | Number of Participants With or Without Myocardial Infarction | Lost to follow-up | 6 Participants |
Secondary
Number of Participants With or Without Silent Stroke
rate, on MRI
Time frame: 6 month
Population: 14 Stroke patients who enrolled and consented in study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants With or Without Silent Stroke | Yes, silent stroke | 1 Participants |
| Intervention | Number of Participants With or Without Silent Stroke | No silent stroke | 7 Participants |
| Intervention | Number of Participants With or Without Silent Stroke | Lost to follow-up | 6 Participants |
Secondary
Number of Participants Without Death
rate
Time frame: 6 month
Population: 14 Stroke patients who enrolled and consented in study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants Without Death | No death | 8 Participants |
| Intervention | Number of Participants Without Death | Lost to follow-up | 6 Participants |
Secondary
Number of Patients With or Without Recurrent Stroke
Recurrent stroke in follow-up period
Time frame: 6 month
Population: 14 Stroke patients who enrolled and consented in study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Patients With or Without Recurrent Stroke | No recurrent stroke | 8 Participants |
| Intervention | Number of Patients With or Without Recurrent Stroke | Lost to follow-up | 6 Participants |