Trial Outcomes & Findings for Transitional Rehabilitation in CABG Patients (NCT NCT03892460)
NCT ID: NCT03892460
Last Updated: 2021-08-03
Results Overview
Short Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair. Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function.
COMPLETED
NA
54 participants
4 weeks
2021-08-03
Participant Flow
Participant milestones
| Measure |
Treatment
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
No treatment control
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
24
|
|
Overall Study
Randomization
|
25
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transitional Rehabilitation in CABG Patients
Baseline characteristics by cohort
| Measure |
Treatment
n=30 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=24 Participants
No treatment control
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 5.9 • n=99 Participants
|
66.5 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
65.7 years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
24 participants
n=107 Participants
|
54 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 weeksShort Physical Performance Battery is composed of three tasks assessing balance, gait speed, and ability to stand from a chair. Units on a scale for each domain range from of 0-4 for a total score of 0 to 12, with a higher score indicating better physical function.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Short Physical Performance Battery
Discharge
|
7.33 units on a scale
Standard Error 0.55
|
8.00 units on a scale
Standard Error 0.54
|
|
Short Physical Performance Battery
4-weeks post-discharge
|
11.44 units on a scale
Standard Error 0.22
|
10.90 units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: 4 weeks6 MW was developed to assess cardiopulmonary fitness in patients with lung and cardiac disease, and has been validated in cardiac surgery patients. It assesses the distance that a patient can walk in 6 minutes time around a standard course.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
6 Minute Walk Distance
Discharge
|
216 meters
Standard Error 22
|
238 meters
Standard Error 21
|
|
6 Minute Walk Distance
4-weeks post-discharge
|
482 meters
Standard Error 21
|
431 meters
Standard Error 20
|
SECONDARY outcome
Timeframe: Hospital discharge and 4-weeks post-dischargeThe Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on limitations in physical function due to health problems. Lower scores represent more physical function disability, while higher scores represent less disability.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Medical Outcomes Short Form 36 - Physical Function
Discharge
|
40 units on a scale
Standard Error 7
|
33 units on a scale
Standard Error 7
|
|
Medical Outcomes Short Form 36 - Physical Function
4-weeks post-discharge
|
70 units on a scale
Standard Error 5
|
58 units on a scale
Standard Error 5
|
SECONDARY outcome
Timeframe: Hospital discharge and 4-weeks post-dischargeThe Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on limitations in usual role activities because of physical health problems. Lower scores represent more disability, while higher scores represent less disability.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Medical Outcome Short Form 36 - Role Physical
Discharge
|
26 units on a scale
Standard Error 10
|
21 units on a scale
Standard Error 9
|
|
Medical Outcome Short Form 36 - Role Physical
4-weeks post-discharge
|
19 units on a scale
Standard Error 8
|
18 units on a scale
Standard Error 7
|
SECONDARY outcome
Timeframe: Hospital discharge and 4-week post-dischargeThe Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on bodily pain. Lower scores represent more pain, while higher scores represent less pain.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Medical Outcomes Short Form 36 - Bodily Pain
Discharge
|
31 units on a scale
Standard Error 4
|
28 units on a scale
Standard Error 4
|
|
Medical Outcomes Short Form 36 - Bodily Pain
4-weeks post-discharge
|
28 units on a scale
Standard Error 3
|
27 units on a scale
Standard Error 3
|
SECONDARY outcome
Timeframe: Hospital discharge and 4-week post-dischargeThe Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on self-reported general health. Lower scores represent worse health, while higher scores represent better health.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Medical Outcomes Short Form 36 - General Health
Discharge
|
71 units on a scale
Standard Error 4
|
63 units on a scale
Standard Error 4
|
|
Medical Outcomes Short Form 36 - General Health
4-weeks post-discharge
|
81 units on a scale
Standard Error 3
|
72 units on a scale
Standard Error 3
|
SECONDARY outcome
Timeframe: Hospital discharge and 4-weeks post-dischargeThe Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focused on vitality (energy and fatigue). Lower scores represent less vitality, while higher scores represent more vitality.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Medical Outcomes Short Form 36 - Vitality
Discharge
|
55 units on a scale
Standard Error 5
|
53 units on a scale
Standard Error 5
|
|
Medical Outcomes Short Form 36 - Vitality
4-weeks post-discharge
|
55 units on a scale
Standard Error 4
|
51 units on a scale
Standard Error 3
|
SECONDARY outcome
Timeframe: Hospital discharge and 4-weeks post-dischargeThe Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focuses on limitations in social activities because of physical or emotional problems. Lower scores represent more more limitations, while higher scores represent less lmitations.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Medical Outcomes Short Form 36 - Social Function
Discharge
|
74 units on a scale
Standard Error 7
|
63 units on a scale
Standard Error 7
|
|
Medical Outcomes Short Form 36 - Social Function
4-week post-discharge
|
76 units on a scale
Standard Error 6
|
72 units on a scale
Standard Error 5
|
SECONDARY outcome
Timeframe: Hospital discharge and 4-week dischargeThe Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This sub-domain focuses on limitations in usual role activities because of emotional problems. Lower scores represent more limitations, while higher scores represent less limitations.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Medical Outcomes Short Form 36 - Role Emotional
Discharge
|
65 units on a scale
Standard Error 11
|
54 units on a scale
Standard Error 11
|
|
Medical Outcomes Short Form 36 - Role Emotional
4-week post-discharge
|
72 units on a scale
Standard Error 10
|
51 units on a scale
Standard Error 9
|
SECONDARY outcome
Timeframe: Hospital discharge and 4-week post-dischargeThe Medical Outcomes Short Form 36 is a questionnaire that assesses self-reported health and physical functional status. There are 36 questions that reflect eight sub-domains of health included in this questionnaire. Scores for each domain represent weighted sums of the questions in each sub-domain. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. This measure represents the total computed score across all sub-domains. Lower scores represent worse overall health, while higher scores represent better health.
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Medical Outcomes Short Form 36
Discharge
|
77 units on a scale
Standard Error 4
|
74 units on a scale
Standard Error 4
|
|
Medical Outcomes Short Form 36
4-week post-discharge
|
86 units on a scale
Standard Error 4
|
78 units on a scale
Standard Error 3
|
SECONDARY outcome
Timeframe: Daily from discharge to 4-week post-discharge evaluationPhysical activity was measured throughout the intervention in control and treatment groups and data. Data were analyzed by regression analysis to obtain the best fit line for the data and to compute a slope of the change in step count with day post-discharge to examine whether groups differed in their rate of recovery of weight-bearing activity (ie, walking).
Outcome measures
| Measure |
Treatment
n=18 Participants
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=19 Participants
No treatment control
|
|---|---|---|
|
Physical Activity
|
125.6 step counts per day
|
109.6 step counts per day
|
Adverse Events
Treatment
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=30 participants at risk
Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation
|
Control
n=24 participants at risk
No treatment control
|
|---|---|---|
|
Cardiac disorders
Pleuritic chest pain
|
3.3%
1/30 • Number of events 30 • 1-month post-surgery
|
0.00%
0/24 • 1-month post-surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place