Trial Outcomes & Findings for Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE) (NCT NCT03423238)
NCT ID: NCT03423238
Last Updated: 2021-11-23
Results Overview
Total number of participants who met all inclusion/exclusion criteria and were enrolled in the study
COMPLETED
NA
38 participants
18 months
2021-11-23
Participant Flow
Participant milestones
| Measure |
Rehab Only
Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
|
Rehab+Weight Loss (WL)
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Rehab Only
Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
|
Rehab+Weight Loss (WL)
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Targeting Obesity to Optimize Health in Cardiac Rehab (TOPCARE)
Baseline characteristics by cohort
| Measure |
Rehab Only
n=19 Participants
Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsTotal number of participants who met all inclusion/exclusion criteria and were enrolled in the study
Outcome measures
| Measure |
All Participants
n=38 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Feasibility - Number of Enrolled Participants
|
38 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsThe percentage of exercise/counseling sessions attended (calculated as the number of sessions attended divided by the number of sessions prescribed multiplied by 100)
Outcome measures
| Measure |
All Participants
n=17 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Compliance - Percentage of Sessions Attended
Dietary compliance
|
NA percentage of sessions attended
Standard Deviation NA
Dietary compliance was not assessed in the Rehab Only group.
|
98.2 percentage of sessions attended
Standard Deviation 1.9
|
|
Compliance - Percentage of Sessions Attended
Exercise compliance
|
45.2 percentage of sessions attended
Standard Deviation 27.5
|
68.6 percentage of sessions attended
Standard Deviation 16.6
|
PRIMARY outcome
Timeframe: 6 monthsThe number of participants who returned for the 6-month follow-up visit divided by the total number of randomized participants multiplied by 100
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Retention - Percentage of Participants Who Returned for Follow-up Testing
|
17 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: BaselineBody weight measured in kg
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Body Weight
|
108.76 kg
Standard Deviation 19.32
|
102.85 kg
Standard Deviation 22.27
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
Body weight measured in kg
Outcome measures
| Measure |
All Participants
n=15 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Body Weight
Month 3
|
104.852 kg
Standard Error 0.930
|
101.658 kg
Standard Error 0.854
|
|
Body Weight
Month 6
|
104.811 kg
Standard Error 1.290
|
99.122 kg
Standard Error 1.140
|
SECONDARY outcome
Timeframe: BaselineThe 6MW test is a valid and reproducible measure of submaximal exercise capacity that reflects the level at which most activities of daily living are performed, predicts clinical events in cardiac patients, and is therefore a clinically meaningful outcome in cardiac rehabilitation studies. Participants were asked to walk at their own maximal pace on an established course, covering as much ground as they can during the allotted time, without running. Performance was measured by the total distance covered in meters.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
6 Minute Walk (6MW) Test
|
441.37 meters
Standard Deviation 81.86
|
429.47 meters
Standard Deviation 79.95
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 3 did not complete Month 3 testing due to a broken foot (n=1), could not be reached (n=1), and safety/health concerns (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 3 testing due to safety/health concerns; 1 did not complete Month 6 testing due to a COVID related pause on in-person research.
The 6MW test is a valid and reproducible measure of submaximal exercise capacity that reflects the level at which most activities of daily living are performed, predicts clinical events in cardiac patients, and is therefore a clinically meaningful outcome in cardiac rehabilitation studies. Participants were asked to walk at their own maximal pace on an established course, covering as much ground as they can during the allotted time, without running. Performance was measured by the total distance covered in meters.
Outcome measures
| Measure |
All Participants
n=14 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=18 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
6 Minute Walk (6MW) Test
Month 3
|
452.962 meters
Standard Error 10.935
|
446.916 meters
Standard Error 9.867
|
|
6 Minute Walk (6MW) Test
Month 6
|
448.506 meters
Standard Error 14.479
|
462.986 meters
Standard Error 12.668
|
SECONDARY outcome
Timeframe: BaselinePopulation: 2 participants (Rehab+WL) did not complete baseline testing due to safety/health concerns (n=2, Rehab+WL).
Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=17 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Grip Strength
|
34.21 kg
Standard Deviation 8.74
|
35.94 kg
Standard Deviation 8.40
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 2 subjects did not complete Month 3 testing due to safety/health concerns; 3 did not complete Month 6 testing due to a COVID related pause on in-person research (n=1) or safety/health concerns (n=2).
Grip strength was measured twice in each hand using an isometric hydraulic hand dynamometer.
Outcome measures
| Measure |
All Participants
n=15 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=17 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Grip Strength
Month 3
|
33.711 kg
Standard Error 1.242
|
33.652 kg
Standard Error 1.182
|
|
Grip Strength
Month 6
|
34.534 kg
Standard Error 1.218
|
35.837 kg
Standard Error 1.082
|
SECONDARY outcome
Timeframe: BaselineMobility was assessed using the MAT-sf, a 10-item computer-based, self-administered assessment that uses animated video clips of 10 different tasks to illustrate various mobility-related challenges that cover a broad range of functioning. Participants provide an assessment of their ability to perform each task on the computer by clicking the appropriate response (yes/no, number of minutes, number of times). Scores range from 30 to 80, with higher scores indicative of better mobility.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Mobility - MAT-sf
|
64.87 score on a scale
Standard Deviation 8.72
|
61.47 score on a scale
Standard Deviation 8.44
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 3 did not complete Month 3 testing due to a broken foot (n=1), could not be reached (n=1), and technical difficulties (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
Mobility was assessed using the MAT-sf, a 10-item computer-based, self-administered assessment that uses animated video clips of 10 different tasks to illustrate various mobility-related challenges that cover a broad range of functioning. Participants provide an assessment of their ability to perform each task on the computer by clicking the appropriate response (yes/no, number of minutes, number of times). Scores range from 30 to 80, with higher scores indicative of better mobility.
Outcome measures
| Measure |
All Participants
n=14 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Mobility - MAT-sf
Month 3
|
64.839 score on a scale
Standard Deviation 1.484
|
65.212 score on a scale
Standard Deviation 1.332
|
|
Mobility - MAT-sf
Month 6
|
64.613 score on a scale
Standard Deviation 2.144
|
65.069 score on a scale
Standard Deviation 1.848
|
SECONDARY outcome
Timeframe: BaselineThe expanded Short Physical Performance Battery (eSPPB) is a modified version of a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. To minimize ceiling effects and maximize overall dispersion of test scores, the eSPPB increases the holding time of the semi- and full-tandem stands to 30 seconds and adds a single leg stand and a narrow walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Expanded Short Physical Performance Battery (eSPPB)
|
1.99 score on a scale
Standard Deviation 0.42
|
2.08 score on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
The expanded Short Physical Performance Battery (eSPPB) is a modified version of a widely used assessment of lower extremity physical function that consists of 3 standing balance tasks held for 10 seconds each (side-by-side, tandem and semi-tandem), two 4-m walk tests to assess usual gait speed, and 5 repeated chair stands. To minimize ceiling effects and maximize overall dispersion of test scores, the eSPPB increases the holding time of the semi- and full-tandem stands to 30 seconds and adds a single leg stand and a narrow walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). eSPPB scores are continuous and range from 0 to 4, with higher scores indicative of better performance.
Outcome measures
| Measure |
All Participants
n=15 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Expanded Short Physical Performance Battery (eSPPB)
Month 3
|
2.252 score on a scale
Standard Error 0.069
|
1.992 score on a scale
Standard Error 0.061
|
|
Expanded Short Physical Performance Battery (eSPPB)
Month 6
|
2.121 score on a scale
Standard Error 0.110
|
2.135 score on a scale
Standard Error 0.091
|
SECONDARY outcome
Timeframe: BaselineHealth-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The mental component summary (MCS) score is derived using a factor analysis technique that includes positive weights for the vitality, social functioning, role-emotional, and mental health scales and negative weights for the physical functioning, role-physical, bodily pain and general health scales.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score
|
54.92 score on a scale
Standard Deviation 8.52
|
53.50 score on a scale
Standard Deviation 11.45
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1).
Health-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The mental component summary (MCS) score is derived using a factor analysis technique that includes positive weights for the vitality, social functioning, role-emotional, and mental health scales and negative weights for the physical functioning, role-physical, bodily pain and general health scales.
Outcome measures
| Measure |
All Participants
n=17 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score
Month 3
|
54.778 score on a scale
Standard Error 2.003
|
53.698 score on a scale
Standard Error 1.820
|
|
Health-related Quality of Life SF-36 - Mental Component Summary (MCS) Score
Month 6
|
53.885 score on a scale
Standard Error 2.107
|
55.463 score on a scale
Standard Error 1.995
|
SECONDARY outcome
Timeframe: BaselineHealth-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The physical component summary (PCS) score is derived using a factor analysis technique that includes positive weights for the physical functioning, role-physical, bodily pain, general health and vitality scales and negative weights for the social functioning, role-emotional and mental health scales.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score
|
37.97 score on a scale
Standard Deviation 10.51
|
37.30 score on a scale
Standard Deviation 10.17
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1).
Health-related quality of life was assessed using the Medical Outcomes Study Short Form 36 (SF-36), a 36-item self-report measure with well-documented psychometric properties across a wide range of populations. All items are scored on a 0 to 100 range such that a high score defines a more favorable quality of life. The SF-36 generates eight subscale scores (general health perceptions; physical functioning; role limitations due to physical problems; bodily pain; mental health; role limitations due to emotional problems; vitality; and social functioning) which are generated by averaging items in the same subscale. The physical component summary (PCS) score is derived using a factor analysis technique that includes positive weights for the physical functioning, role-physical, bodily pain, general health and vitality scales and negative weights for the social functioning, role-emotional and mental health scales.
Outcome measures
| Measure |
All Participants
n=17 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score
Month 3
|
42.458 score on a scale
Standard Error 1.771
|
41.595 score on a scale
Standard Error 1.615
|
|
Health-related Quality of Life SF-36 - Physical Component Summary (PCS) Score
Month 6
|
41.949 score on a scale
Standard Error 2.374
|
42.569 score on a scale
Standard Error 2.245
|
SECONDARY outcome
Timeframe: BaselinePopulation: 15 participants (n=8, Rehab Only; n=7, Rehab+WL) did not complete baseline PWV testing due to technical difficulties (i.e., equipment malfunction, could not acquire signal); 1 participant (Rehab Only) refused.
Arterial stiffness was assessed as carotid-femoral pulse wave velocity (PWV). Carotid-femoral PWV was measured in the supine position using the SphygmoCor XCEL system. PWV is calculated by dividing the distance between the carotid and femoral arteries by the pulse transit time.
Outcome measures
| Measure |
All Participants
n=10 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=12 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Arterial Stiffness
|
8.67 m/s
Standard Deviation 2.53
|
8.40 m/s
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 8 did not complete Month 3 testing due to a broken foot (n=1), could not be reached (n=1), and technical issues (n=6); 11 did not complete Month 6 testing due to a COVID related pause (n=5) and technical issues (n=6). Rehab+WL: 2 subjects did not complete Month 3 testing due to technical issues; 4 did not complete Month 6 testing due to a COVID related pause (n=1) and technical issues (n=3)
Arterial stiffness was assessed as carotid-femoral pulse wave velocity (PWV). Carotid-femoral PWV was measured in the supine position using the SphygmoCor XCEL system. PWV is calculated by dividing the distance between the carotid and femoral arteries by the pulse transit time.
Outcome measures
| Measure |
All Participants
n=9 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=17 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Arterial Stiffness
Month 3
|
8.760 m/s
Standard Error 0.768
|
8.061 m/s
Standard Error 0.616
|
|
Arterial Stiffness
Month 6
|
9.611 m/s
Standard Error 0.719
|
8.487 m/s
Standard Error 0.567
|
SECONDARY outcome
Timeframe: BaselineBrachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Brachial Blood Pressure - Systolic
|
132.84 mmHg
Standard Deviation 21.14
|
128.63 mmHg
Standard Deviation 17.30
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes.
Outcome measures
| Measure |
All Participants
n=15 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Brachial Blood Pressure - Systolic
Month 3
|
124.089 mmHg
Standard Error 3.564
|
126.987 mmHg
Standard Error 3.178
|
|
Brachial Blood Pressure - Systolic
Month 6
|
124.272 mmHg
Standard Error 4.110
|
129.860 mmHg
Standard Error 3.399
|
SECONDARY outcome
Timeframe: BaselineBrachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Brachial Blood Pressure - Diastolic
|
76.26 mmHg
Standard Deviation 14.02
|
75.89 mmHg
Standard Deviation 13.26
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
Brachial blood pressure was measured using a conventional mercury sphygmomanometer with the participant in a seated position after resting quietly for 5-10 minutes.
Outcome measures
| Measure |
All Participants
n=15 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Brachial Blood Pressure - Diastolic
Month 3
|
70.024 mmHg
Standard Error 2.166
|
69.247 mmHg
Standard Error 1.962
|
|
Brachial Blood Pressure - Diastolic
Month 6
|
72.738 mmHg
Standard Error 2.546
|
69.989 mmHg
Standard Error 2.168
|
SECONDARY outcome
Timeframe: BaselinePopulation: 1 participant (Rehab Only) did not complete baseline testing due to safety/health concerns.
Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in the supine position after resting quietly for 5-10 minutes.
Outcome measures
| Measure |
All Participants
n=18 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Aortic Blood Pressure - Systolic
|
132.89 mmHg
Standard Deviation 19.33
|
130.47 mmHg
Standard Deviation 16.57
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in a supine position after resting quietly for 5-10 minutes.
Outcome measures
| Measure |
All Participants
n=15 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Aortic Blood Pressure - Systolic
Month 3
|
130.234 mmHg
Standard Error 3.650
|
129.328 mmHg
Standard Error 3.255
|
|
Aortic Blood Pressure - Systolic
Month 6
|
127.204 mmHg
Standard Error 3.203
|
126.692 mmHg
Standard Error 2.647
|
SECONDARY outcome
Timeframe: BaselinePopulation: 1 participant (Rehab Only) did not complete baseline testing due to safety/health concerns.
Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in a supine position after resting quietly for 5-10 minutes.
Outcome measures
| Measure |
All Participants
n=18 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Aortic Blood Pressure - Diastolic
|
83.72 mmHg
Standard Deviation 15.23
|
81.11 mmHg
Standard Deviation 12.36
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
Aortic blood pressure was measured using the SphygmoCor XCEL system with the participant in a supine position after resting quietly for 5-10 minutes.
Outcome measures
| Measure |
All Participants
n=15 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Aortic Blood Pressure - Diastolic
Month 3
|
78.322 mmHg
Standard Error 2.127
|
78.965 mmHg
Standard Error 1.905
|
|
Aortic Blood Pressure - Diastolic
Month 6
|
76.221 mmHg
Standard Error 2.307
|
78.783 mmHg
Standard Error 1.924
|
SECONDARY outcome
Timeframe: BaselineHemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Hemoglobin A1c
|
6.36 percentage of hemoglobin glycated
Standard Deviation 0.97
|
5.94 percentage of hemoglobin glycated
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
Hemoglobin A1c was measured in whole blood using a turbidimetric inhibition immunoassay.
Outcome measures
| Measure |
All Participants
n=15 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Hemoglobin A1c
Month 3
|
6.046 percentage of hemoglobin glycated
Standard Error 0.143
|
6.239 percentage of hemoglobin glycated
Standard Error 0.134
|
|
Hemoglobin A1c
Month 6
|
6.033 percentage of hemoglobin glycated
Standard Error 0.163
|
6.190 percentage of hemoglobin glycated
Standard Error 0.148
|
SECONDARY outcome
Timeframe: BaselineInsulin was determined by a chemiluminescent immunoassay.
Outcome measures
| Measure |
All Participants
n=19 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Fasting Insulin
|
22.67 mg/dl
Standard Deviation 14.24
|
20.08 mg/dl
Standard Deviation 10.89
|
SECONDARY outcome
Timeframe: Months 3 and 6Population: All available follow-up data were included. Rehab Only: 2 subjects dropped out prior to follow-up testing; 2 did not complete Month 3 testing due to a broken foot (n=1) and could not be reached (n=1); 5 did not complete Month 6 testing due to a COVID related pause on in-person research. Rehab+WL: 1 subject did not complete Month 6 testing due to a COVID related pause on in-person research.
Insulin was determined by a chemiluminescent immunoassay.
Outcome measures
| Measure |
All Participants
n=15 Participants
Includes all eligible participants prior to randomization
|
Rehab+Weight Loss (WL)
n=19 Participants
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Fasting Insulin
Month 6
|
17.558 mg/dl
Standard Error 3.276
|
19.623 mg/dl
Standard Error 2.878
|
|
Fasting Insulin
Month 3
|
20.161 mg/dl
Standard Error 2.626
|
20.197 mg/dl
Standard Error 2.414
|
Adverse Events
Rehab Only
Rehab+Weight Loss (WL)
Serious adverse events
| Measure |
Rehab Only
n=19 participants at risk
Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
|
Rehab+Weight Loss (WL)
n=19 participants at risk
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Cardiac disorders
Angina/Percutaneous coronary intervention procedure
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Left basilar pneumonia
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
Other adverse events
| Measure |
Rehab Only
n=19 participants at risk
Patients will be randomized to Rehab only using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation, which includes meeting with dietitian, exercise, health education, and exercise compliance.
|
Rehab+Weight Loss (WL)
n=19 participants at risk
Patients will be randomized to Rehab+WL using a randomization scheme with blocking stratified by sex and obesity severity (BMI\<30 vs. BMI≥30 kg/m2). All participants will undergo standard exercise-based cardiac rehabilitation in addition to a weight-loss intervention, which includes meeting with dietitian, exercise, health education, and exercise compliance, calorie-restricted diet, behavioral modification, and weight-loss compliance.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
acute bronchitis and URI
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain-Pinched nerve
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Musculoskeletal and connective tissue disorders
bilateral feet and leg pain, left leg and foot pain worse
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Musculoskeletal and connective tissue disorders
bilateral hip pain
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Bleeding diabetic ulcer
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Gastrointestinal disorders
Diarrhea and Nausea
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Cardiac disorders
elevated BP and low oxygen/wound
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Facial Cellulitis
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
10.5%
2/19 • Number of events 2 • 6 months
|
0.00%
0/19 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Flu symptoms
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Groin strain
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Musculoskeletal and connective tissue disorders
left ankle fracture and left midfoot fractures
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Musculoskeletal and connective tissue disorders
left hip pain
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
left knee pain
|
5.3%
1/19 • Number of events 1 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
left leg injury
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
nauseous possibly due to low blood sugar
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Outpatient ablation procedure
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Eye disorders
pink eye
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Cardiac disorders
Postural Dizziness with presynscope
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Surgical and medical procedures
pre-planned outpatient ablation procedure
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pulled muscle in back and left knee
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Musculoskeletal and connective tissue disorders
right ankle and heel pain
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus allergy
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Strep Throat and flu like symptoms
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
|
Blood and lymphatic system disorders
Fluid overload and increasing shortness of breath
|
0.00%
0/19 • 6 months
|
5.3%
1/19 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Blood loss
|
5.3%
1/19 • Number of events 1 • 6 months
|
0.00%
0/19 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place