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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Coronary Artery Bypass Graft Surgery Device: neuromuscular electrical stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : October 24, 2019
Actual Study Completion Date : October 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Neuromuscular electrical stimulation
Device: neuromuscular electrical stimulation
bilateral quadriceps exercise with neuromuscular electrical stimulation

No Intervention: Control
No treatment control



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 6 Minute Walk Distance [ Time Frame: 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.

  2. Medical Outcomes Short Form 36 - Physical Function [ Time Frame: 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.

  3. Medical Outcome Short Form 36 - Role Physical [ Time Frame: 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.

  4. Medical Outcomes Short Form 36 - Bodily Pain [ Time Frame: 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.

  5. Medical Outcomes Short Form 36 - General Health [ Time Frame: 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. Medical Outcomes Short Form 36 - Vitality [ Time Frame: 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.

  7. Medical Outcomes Short Form 36 - Social Function [ Time Frame: 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.

  8. Medical Outcomes Short Form 36 - Role Emotional [ Time Frame: 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.

  9. Medical Outcomes Short Form 36 [ Time Frame: 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.

  10. Physical Activity [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03892460


Locations
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United States, Vermont
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
  Study Documents (Full-Text)

Documents provided by Michael J. Toth, Ph.D., University of Vermont:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael J. Toth, Ph.D., Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT03892460    
Other Study ID Numbers: 17-0413
First Posted: March 27, 2019    Key Record Dates
Results First Posted: August 3, 2021
Last Update Posted: August 3, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases