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Transitional Rehabilitation in CABG Patients

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ClinicalTrials.gov Identifier: NCT03892460
Recruitment Status : Completed
First Posted : March 27, 2019
Results First Posted : August 3, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Michael J. Toth, Ph.D., University of Vermont

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Coronary Artery Disease
Coronary Artery Bypass Graft Surgery
Intervention Device: neuromuscular electrical stimulation
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Control
Hide Arm/Group Description

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Period Title: Overall Study
Started 30 24
Randomization 25 20
Completed 18 19
Not Completed 12 5
Arm/Group Title Treatment Control Total
Hide Arm/Group Description

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control Total of all reporting groups
Overall Number of Baseline Participants 30 24 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 24 participants 54 participants
64.9  (5.9) 66.5  (7.1) 65.7  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 24 participants 54 participants
Female
3
  10.0%
3
  12.5%
6
  11.1%
Male
27
  90.0%
21
  87.5%
48
  88.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 24 participants 54 participants
Hispanic or Latino
1
   3.3%
0
   0.0%
1
   1.9%
Not Hispanic or Latino
29
  96.7%
24
 100.0%
53
  98.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 24 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.3%
0
   0.0%
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   3.3%
0
   0.0%
1
   1.9%
White
28
  93.3%
24
 100.0%
52
  96.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 24 participants 54 participants
30 24 54
1.Primary Outcome
Title Short Physical Performance Battery
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: units on a scale
Discharge 7.33  (0.55) 8.00  (0.54)
4-weeks post-discharge 11.44  (0.22) 10.90  (0.21)
2.Secondary Outcome
Title 6 Minute Walk Distance
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: meters
Discharge 216  (22) 238  (21)
4-weeks post-discharge 482  (21) 431  (20)
3.Secondary Outcome
Title Medical Outcomes Short Form 36 - Physical Function
Hide Description 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.
Time Frame Hospital discharge and 4-weeks post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:
Neuromuscular electrical stimulation
No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: units on a scale
Discharge 40  (7) 33  (7)
4-weeks post-discharge 70  (5) 58  (5)
4.Secondary Outcome
Title Medical Outcome Short Form 36 - Role Physical
Hide Description 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.
Time Frame Hospital discharge and 4-weeks post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: units on a scale
Discharge 26  (10) 21  (9)
4-weeks post-discharge 19  (8) 18  (7)
5.Secondary Outcome
Title Medical Outcomes Short Form 36 - Bodily Pain
Hide Description 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.
Time Frame Hospital discharge and 4-week post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: units on a scale
Discharge 31  (4) 28  (4)
4-weeks post-discharge 28  (3) 27  (3)
6.Secondary Outcome
Title Medical Outcomes Short Form 36 - General Health
Hide Description 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.
Time Frame Hospital discharge and 4-week post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: units on a scale
Discharge 71  (4) 63  (4)
4-weeks post-discharge 81  (3) 72  (3)
7.Secondary Outcome
Title Medical Outcomes Short Form 36 - Vitality
Hide Description 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.
Time Frame Hospital discharge and 4-weeks post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: units on a scale
Discharge 55  (5) 53  (5)
4-weeks post-discharge 55  (4) 51  (3)
8.Secondary Outcome
Title Medical Outcomes Short Form 36 - Social Function
Hide Description 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.
Time Frame Hospital discharge and 4-weeks post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: units on a scale
Discharge 74  (7) 63  (7)
4-week post-discharge 76  (6) 72  (5)
9.Secondary Outcome
Title Medical Outcomes Short Form 36 - Role Emotional
Hide Description 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.
Time Frame Hospital discharge and 4-week discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: units on a scale
Discharge 65  (11) 54  (11)
4-week post-discharge 72  (10) 51  (9)
10.Secondary Outcome
Title Medical Outcomes Short Form 36
Hide Description 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.
Time Frame Hospital discharge and 4-week post-discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Mean (Standard Error)
Unit of Measure: units on a scale
Discharge 77  (4) 74  (4)
4-week post-discharge 86  (4) 78  (3)
11.Secondary Outcome
Title Physical Activity
Hide Description 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).
Time Frame Daily from discharge to 4-week post-discharge evaluation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Control
Hide Arm/Group Description:

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
Overall Number of Participants Analyzed 18 19
Measure Type: Number
Unit of Measure: step counts per day
125.6 109.6
Time Frame 1-month post-surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Control
Hide Arm/Group Description

Neuromuscular electrical stimulation

neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation

No treatment control
All-Cause Mortality
Treatment Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/24 (0.00%)    
Hide Serious Adverse Events
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/24 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      0/24 (0.00%)    
Cardiac disorders     
Pleuritic chest pain  [1]  1/30 (3.33%)  30 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Pleuritic chest pain during functional stesting
First, patients were not blinded to treatment status because NMES elicits skeletal muscle contraction and any sham treatment would not. Second, study personnel were not blinded, as resources were insufficient for unblinded and blinded personnel. Third, we did not analyze data using an intent-to-treat approach. Fourth, our study included few women. Finally, our study is limited to the strict inclusion/exclusion criteria and studies in larger cohorts are required to assess external validity.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Toth
Organization: University of Vermont College of Medicine
Phone: 802-656-7989
EMail: michael.toth@med.uvm.edu
Layout table for additonal information
Responsible Party: Michael J. Toth, Ph.D., University of Vermont
ClinicalTrials.gov Identifier: NCT03892460    
Other Study ID Numbers: 17-0413
First Submitted: March 26, 2019
First Posted: March 27, 2019
Results First Submitted: April 28, 2021
Results First Posted: August 3, 2021
Last Update Posted: August 3, 2021