Coronary Artery Bypass Graft Surgery, Coronary Artery Disease
Conditions
Brief summary
The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can preserve or improve physical function.
Detailed description
Coronary artery bypass graft (CABG) surgery is a common surgical procedures and an important treatment option for coronary artery disease. The post-surgery period of rest and recovery is associated with cardiorespiratory and skeletal muscle deconditioning. The goal of this research study is to understand whether an at-home exercise program started soon after CABG surgery, and continuing for 4 weeks following discharge from the hospital, can serve as a bridge between surgery and the start of cardiac rehabilitation to preserve or improve physical function. Volunteers will be randomly assigned to receive neuromuscular electrical stimulation (NMES) of their quadriceps muscles or not to receive NMES (control group). Volunteers will be evaluated prior to CABG, upon discharge and 4 weeks Post-CABG surgery. Assessments will include measurements of physical function by the Short Physical Performance Battery, 6 min walk tests and body composition analysis, as well as assessment of subjective physical functional capacity and quality of life using the Medical Outcomes Short form 36. Additionally, accelerometry will be used to monitor weight-bearing physical activity during the 4 week treatment phase.
Interventions
DEVICEneuromuscular electrical stimulation
bilateral quadriceps exercise with neuromuscular electrical stimulation
Sponsors
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 50-80 yrs of age * ambulatory * scheduled for coronary artery bypass graft surgery * able to provide informed consent
Exclusion criteria
* rheumatoid arthritis or other inflammatory/autoimmune disease * cancer, excluding non-melanoma skin cancer * exercise limiting peripheral vascular disease * neuromuscular disease or neuromuscular dysfunction associated with cerebrovascular event * body mass index \>38 kg/m2 * valvular heart disease not corrected surgically * lower extremity blood clot or implantable cardioverter-defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical Outcomes Short Form 36 - Physical Function | 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. |
| Medical Outcome Short Form 36 - Role Physical | 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. |
| Medical Outcomes Short Form 36 - Bodily Pain | 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. |
| Medical Outcomes Short Form 36 - General Health | 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. |
| 6 Minute Walk Distance | 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. |
| Medical Outcomes Short Form 36 - Social Function | 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. |
| Medical Outcomes Short Form 36 - Role Emotional | 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. |
| Medical Outcomes Short Form 36 | 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. |
| Physical Activity | 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). |
| Medical Outcomes Short Form 36 - Vitality | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Neuromuscular electrical stimulation
neuromuscular electrical stimulation: bilateral quadriceps exercise with neuromuscular electrical stimulation | 30 |
| Control No treatment control | 24 |
| Total | 54 |
Baseline characteristics
| Characteristic | Treatment | Total | Control |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 5.9 | 65.7 years STANDARD_DEVIATION 6.4 | 66.5 years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 53 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 52 Participants | 24 Participants |
| Region of Enrollment United States | 30 participants | 54 participants | 24 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 27 Participants | 48 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 24 |
| other Total, other adverse events | 1 / 30 | 0 / 24 |
| serious Total, serious adverse events | 0 / 30 | 0 / 24 |
Outcome results
Primary
Short Physical Performance Battery
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Short Physical Performance Battery | Discharge | 7.33 units on a scale | Standard Error 0.55 |
| Treatment | Short Physical Performance Battery | 4-weeks post-discharge | 11.44 units on a scale | Standard Error 0.22 |
| Control | Short Physical Performance Battery | Discharge | 8.00 units on a scale | Standard Error 0.54 |
| Control | Short Physical Performance Battery | 4-weeks post-discharge | 10.90 units on a scale | Standard Error 0.21 |
Secondary
6 Minute Walk Distance
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | 6 Minute Walk Distance | Discharge | 216 meters | Standard Error 22 |
| Treatment | 6 Minute Walk Distance | 4-weeks post-discharge | 482 meters | Standard Error 21 |
| Control | 6 Minute Walk Distance | Discharge | 238 meters | Standard Error 21 |
| Control | 6 Minute Walk Distance | 4-weeks post-discharge | 431 meters | Standard Error 20 |
Secondary
Medical Outcome Short Form 36 - Role Physical
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Medical Outcome Short Form 36 - Role Physical | Discharge | 26 units on a scale | Standard Error 10 |
| Treatment | Medical Outcome Short Form 36 - Role Physical | 4-weeks post-discharge | 19 units on a scale | Standard Error 8 |
| Control | Medical Outcome Short Form 36 - Role Physical | Discharge | 21 units on a scale | Standard Error 9 |
| Control | Medical Outcome Short Form 36 - Role Physical | 4-weeks post-discharge | 18 units on a scale | Standard Error 7 |
Secondary
Medical Outcomes Short Form 36
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Medical Outcomes Short Form 36 | Discharge | 77 units on a scale | Standard Error 4 |
| Treatment | Medical Outcomes Short Form 36 | 4-week post-discharge | 86 units on a scale | Standard Error 4 |
| Control | Medical Outcomes Short Form 36 | Discharge | 74 units on a scale | Standard Error 4 |
| Control | Medical Outcomes Short Form 36 | 4-week post-discharge | 78 units on a scale | Standard Error 3 |
Secondary
Medical Outcomes Short Form 36 - Bodily Pain
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Medical Outcomes Short Form 36 - Bodily Pain | Discharge | 31 units on a scale | Standard Error 4 |
| Treatment | Medical Outcomes Short Form 36 - Bodily Pain | 4-weeks post-discharge | 28 units on a scale | Standard Error 3 |
| Control | Medical Outcomes Short Form 36 - Bodily Pain | Discharge | 28 units on a scale | Standard Error 4 |
| Control | Medical Outcomes Short Form 36 - Bodily Pain | 4-weeks post-discharge | 27 units on a scale | Standard Error 3 |
Secondary
Medical Outcomes Short Form 36 - General Health
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Medical Outcomes Short Form 36 - General Health | Discharge | 71 units on a scale | Standard Error 4 |
| Treatment | Medical Outcomes Short Form 36 - General Health | 4-weeks post-discharge | 81 units on a scale | Standard Error 3 |
| Control | Medical Outcomes Short Form 36 - General Health | Discharge | 63 units on a scale | Standard Error 4 |
| Control | Medical Outcomes Short Form 36 - General Health | 4-weeks post-discharge | 72 units on a scale | Standard Error 3 |
Secondary
Medical Outcomes Short Form 36 - Physical Function
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Medical Outcomes Short Form 36 - Physical Function | Discharge | 40 units on a scale | Standard Error 7 |
| Treatment | Medical Outcomes Short Form 36 - Physical Function | 4-weeks post-discharge | 70 units on a scale | Standard Error 5 |
| Control | Medical Outcomes Short Form 36 - Physical Function | Discharge | 33 units on a scale | Standard Error 7 |
| Control | Medical Outcomes Short Form 36 - Physical Function | 4-weeks post-discharge | 58 units on a scale | Standard Error 5 |
Secondary
Medical Outcomes Short Form 36 - Role Emotional
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Medical Outcomes Short Form 36 - Role Emotional | Discharge | 65 units on a scale | Standard Error 11 |
| Treatment | Medical Outcomes Short Form 36 - Role Emotional | 4-week post-discharge | 72 units on a scale | Standard Error 10 |
| Control | Medical Outcomes Short Form 36 - Role Emotional | Discharge | 54 units on a scale | Standard Error 11 |
| Control | Medical Outcomes Short Form 36 - Role Emotional | 4-week post-discharge | 51 units on a scale | Standard Error 9 |
Secondary
Medical Outcomes Short Form 36 - Social Function
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Medical Outcomes Short Form 36 - Social Function | Discharge | 74 units on a scale | Standard Error 7 |
| Treatment | Medical Outcomes Short Form 36 - Social Function | 4-week post-discharge | 76 units on a scale | Standard Error 6 |
| Control | Medical Outcomes Short Form 36 - Social Function | Discharge | 63 units on a scale | Standard Error 7 |
| Control | Medical Outcomes Short Form 36 - Social Function | 4-week post-discharge | 72 units on a scale | Standard Error 5 |
Secondary
Medical Outcomes Short Form 36 - Vitality
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Medical Outcomes Short Form 36 - Vitality | Discharge | 55 units on a scale | Standard Error 5 |
| Treatment | Medical Outcomes Short Form 36 - Vitality | 4-weeks post-discharge | 55 units on a scale | Standard Error 4 |
| Control | Medical Outcomes Short Form 36 - Vitality | Discharge | 53 units on a scale | Standard Error 5 |
| Control | Medical Outcomes Short Form 36 - Vitality | 4-weeks post-discharge | 51 units on a scale | Standard Error 3 |
Secondary
Physical Activity
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Physical Activity | 125.6 step counts per day |
| Control | Physical Activity | 109.6 step counts per day |