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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

4 weeks

Results posted on

2021-08-03

Participant Flow

Participant milestones

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

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 weeks

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.

Outcome measures

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 weeks

6 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

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-discharge

The 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

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-discharge

The 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

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-discharge

The 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

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-discharge

The 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

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-discharge

The 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

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-discharge

The 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

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 discharge

The 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

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-discharge

The 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

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 evaluation

Physical 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

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

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Michael Toth

University of Vermont College of Medicine

Phone: 802-656-7989

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place