Coronary Artery DiseaseNCT03892460
Transitional Rehabilitation in CABG Patients
A study testing neuromuscular electrical stimulation in people with Coronary Artery Disease and Coronary Artery Bypass Graft Surgery, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Graft Surgery
- What is being tested?
- neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 24 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-80 yrs of age
- ambulatory
- scheduled for coronary artery bypass graft surgery
- able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont College of Medicine
Burlington, Vermont, 05405
About this study
Official title: Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients
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.
Read the 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.
- Being tested
- neuromuscular electrical stimulation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular electrical stimulationDevice
bilateral quadriceps exercise with neuromuscular electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Neuromuscular electrical stimulation Receives: Device: neuromuscular electrical stimulation |
| Control | No intervention | No treatment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (10)
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.
Measured: 4 weeks
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.
Measured: Hospital discharge and 4-weeks post-discharge
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.
Measured: Hospital discharge and 4-weeks post-discharge
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.
Measured: Hospital discharge and 4-week post-discharge
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.
Measured: Hospital discharge and 4-week post-discharge
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.
Measured: Hospital discharge and 4-weeks post-discharge
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.
Measured: Hospital discharge and 4-weeks post-discharge
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.
Measured: Hospital discharge and 4-week discharge
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.
Measured: Hospital discharge and 4-week post-discharge
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).
Measured: Daily from discharge to 4-week post-discharge evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Sep 2017
- Primary completion24 Oct 2019
- Study completion24 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Toth, Ph.D., University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892460
- Sponsor's protocol ID
- 17-0413
- Status last verified
- Jul 2021
- First submitted
- 26 Mar 2019
- Last updated
- 3 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rengo JL, Savage PD, Hirashima F, Leavitt BJ, Ades PA, Toth MJ. Improvement in Physical Function After Coronary Artery Bypass Graft Surgery Using a Novel Rehabilitation Intervention: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2021 Nov 1;41(6):413-418. doi: 10.1097/HCR.0000000000000576.
PubMed 33512980
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients
- ClinicalTrials.gov ID
- NCT03892460
- Acronym / sponsor ID
- 17-0413
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Posted 3 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: neuromuscular electrical stimulationNeuromuscular electrical stimulation |
| Control | No intervention | –No treatment control |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50-80 yrs of age
- ambulatory
- scheduled for coronary artery bypass graft surgery
- able to provide informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular electrical stimulationbilateral quadriceps exercise with neuromuscular electrical stimulation | Device | Treatment |
Primary outcome
Short Physical Performance Battery
Time frame: 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.
10 secondary outcomes
6 Minute Walk Distance
Time frame: 4 weeks
Medical Outcomes Short Form 36 - Physical Function
Time frame: Hospital discharge and 4-weeks post-discharge
Medical Outcome Short Form 36 - Role Physical
Time frame: Hospital discharge and 4-weeks post-discharge
Medical Outcomes Short Form 36 - Bodily Pain
Time frame: Hospital discharge and 4-week post-discharge
Medical Outcomes Short Form 36 - General Health
Time frame: Hospital discharge and 4-week post-discharge
Medical Outcomes Short Form 36 - Vitality
Time frame: Hospital discharge and 4-weeks post-discharge
Medical Outcomes Short Form 36 - Social Function
Time frame: Hospital discharge and 4-weeks post-discharge
Medical Outcomes Short Form 36 - Role Emotional
Time frame: Hospital discharge and 4-week discharge
Medical Outcomes Short Form 36
Time frame: Hospital discharge and 4-week post-discharge
Physical Activity
Time frame: Daily from discharge to 4-week post-discharge evaluation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33512980Rengo JL, Savage PD, Hirashima F, Leavitt BJ, Ades PA, Toth MJ. Improvement in Physical Function After Coronary Artery Bypass Graft Surgery Using a Novel Rehabilitation Intervention: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2021 Nov 1;41(6):413-418. doi: 10.1097/HCR.0000000000000576.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuromuscular electrical stimulation in people with Coronary Artery Disease and Coronary Artery Bypass Graft Surgery, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03892460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.