Trial Outcomes & Findings for Comprehensive Cardiac Rehabilitation Feasibility After Stroke (NCT NCT03944668)
NCT ID: NCT03944668
Last Updated: 2023-05-16
Results Overview
75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-05-16
Participant Flow
32 patients assessed for eligibility * 9 refused to participate * 6 unable to reach
Participant milestones
| Measure |
Intervention
Exercise intervention
Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Able to Use Patient Data
|
14
|
|
Overall Study
Participated in Intervention
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only patients who began CCR Fast exercise program and had baseline physical visit
Baseline characteristics by cohort
| Measure |
Intervention
n=14 Participants
Exercise intervention
Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
|
|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 12.4 • n=14 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
|
Smoking Status
Current
|
4 Participants
n=14 Participants
|
|
Smoking Status
Previous
|
3 Participants
n=14 Participants
|
|
Smoking Status
Never
|
7 Participants
n=14 Participants
|
|
Stroke Mechanism
Cryptogenic
|
3 Participants
n=14 Participants
|
|
Stroke Mechanism
Cardiomebolic
|
3 Participants
n=14 Participants
|
|
Stroke Mechanism
Large Vessel Extracranial
|
4 Participants
n=14 Participants
|
|
Stroke Mechanism
Lacunar
|
2 Participants
n=14 Participants
|
|
Stroke Mechanism
Other/Missing
|
2 Participants
n=14 Participants
|
|
National Institutes of Health Stroke Scale (NIHSS)
|
0.5 units on a scale
n=14 Participants
|
|
Length of Stay for Initial Stroke Admission
|
1.8 days
STANDARD_DEVIATION 1.1 • n=14 Participants
|
|
Weight
|
220.2 lbs
STANDARD_DEVIATION 34.7 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Body Mass Index (BMI)
|
35.1 kg/m^2
STANDARD_DEVIATION 8.0 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Systolic Blood Pressure (SBP)
|
136.9 mmHg
STANDARD_DEVIATION 17.5 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Diastolic Blood Pressure (DBP)
|
78.9 mmHg
STANDARD_DEVIATION 14.4 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Triglycerides
|
188.4 mg/dL
STANDARD_DEVIATION 124.1 • n=9 Participants • Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab
|
|
HDL
|
39.6 mg/dL
STANDARD_DEVIATION 7.3 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
LDL
|
105.7 mg/dL
STANDARD_DEVIATION 36.2 • n=9 Participants • Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab
|
|
Non-HDL
|
139.1 mg/dL
STANDARD_DEVIATION 41.5 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Sodium
|
138.1 mEq/L
STANDARD_DEVIATION 3.1 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Potassium
|
4.0 mEq/L
STANDARD_DEVIATION 0.3 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Chloride
|
103.9 mEq/L
STANDARD_DEVIATION 2.2 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Bicarbonate (cO2)
|
24.1 mEq/L
STANDARD_DEVIATION 3.5 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Glucose
|
141.9 mg/dL
STANDARD_DEVIATION 82 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Creatinine
|
1.0 mg/dL
STANDARD_DEVIATION 0.2 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Calcium
|
9.4 mg/dL
STANDARD_DEVIATION 0.6 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Anion Gap
|
10.4 mEq/L
STANDARD_DEVIATION 1.7 • n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
International Normalized Rate (INR)
|
1.0 ratio
STANDARD_DEVIATION 0.1 • n=7 Participants • Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab
|
|
Prothrombin Time (PT)
|
25.9 seconds
STANDARD_DEVIATION 6.6 • n=6 Participants • Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab
|
|
A1c
|
7.8 mg/dL
STANDARD_DEVIATION 3.6 • n=8 Participants • Only patients who began CCR Fast exercise program, had baseline physical visit, and got results from respective lab
|
|
Glomerular Filtration Rate
> 60
|
7 Participants
n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
|
Glomerular Filtration Rate
< 60
|
3 Participants
n=10 Participants • Only patients who began CCR Fast exercise program and had baseline physical visit
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 14 Stroke patients who enrolled and consented in study
75% attendance at comprehensive cardiovascular rehabilitation (CCR) sessions
Outcome measures
| Measure |
Intervention
n=14 Participants
Exercise intervention
Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
|
|---|---|
|
Attendance Rate
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthPopulation: 14 Stroke patients who enrolled and consented in study
Recurrent stroke in follow-up period
Outcome measures
| Measure |
Intervention
n=14 Participants
Exercise intervention
Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
|
|---|---|
|
Number of Patients With or Without Recurrent Stroke
No recurrent stroke
|
8 Participants
|
|
Number of Patients With or Without Recurrent Stroke
Lost to follow-up
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthPopulation: 14 Stroke patients who enrolled and consented in study
Myocardial infarction in follow-up time
Outcome measures
| Measure |
Intervention
n=14 Participants
Exercise intervention
Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
|
|---|---|
|
Number of Participants With or Without Myocardial Infarction
No myocardial infarction
|
8 Participants
|
|
Number of Participants With or Without Myocardial Infarction
Lost to follow-up
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthPopulation: 14 Stroke patients who enrolled and consented in study
rate, for a cardiovascular or cerebrovascular indication
Outcome measures
| Measure |
Intervention
n=14 Participants
Exercise intervention
Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
|
|---|---|
|
Hospital Readmission
No
|
8 Participants
|
|
Hospital Readmission
Lost to follow-up
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthPopulation: 14 Stroke patients who enrolled and consented in study
rate, on MRI
Outcome measures
| Measure |
Intervention
n=14 Participants
Exercise intervention
Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
|
|---|---|
|
Number of Participants With or Without Silent Stroke
Yes, silent stroke
|
1 Participants
|
|
Number of Participants With or Without Silent Stroke
No silent stroke
|
7 Participants
|
|
Number of Participants With or Without Silent Stroke
Lost to follow-up
|
6 Participants
|
SECONDARY outcome
Timeframe: 6 monthPopulation: 14 Stroke patients who enrolled and consented in study
rate
Outcome measures
| Measure |
Intervention
n=14 Participants
Exercise intervention
Exercise: 36 sessions of comprehensive cardiac rehabilitation over 12 weeks
|
|---|---|
|
Number of Participants Without Death
No death
|
8 Participants
|
|
Number of Participants Without Death
Lost to follow-up
|
6 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amanda Herrmann, PhD
HealthPartners Neuroscience Research
Phone: 651-495-6356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place