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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

Tracking Information
First Submitted Date  ICMJE March 26, 2019
First Posted Date  ICMJE March 27, 2019
Results First Submitted Date  ICMJE April 28, 2021
Results First Posted Date  ICMJE August 3, 2021
Last Update Posted Date August 3, 2021
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
Short Physical Performance Battery [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
6 Minute Walk Distance [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transitional Rehabilitation in CABG Patients
Official Title  ICMJE Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Coronary Artery Disease
  • Coronary Artery Bypass Graft Surgery
Intervention  ICMJE Device: neuromuscular electrical stimulation
bilateral quadriceps exercise with neuromuscular electrical stimulation
Study Arms  ICMJE
  • Experimental: Treatment
    Neuromuscular electrical stimulation
    Intervention: Device: neuromuscular electrical stimulation
  • No Intervention: Control
    No treatment control
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 Jan 25. doi: 10.1097/HCR.0000000000000576. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2020)
54
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2019)
55
Actual Study Completion Date  ICMJE October 24, 2019
Actual Primary Completion Date October 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03892460
Other Study ID Numbers  ICMJE 17-0413
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael J. Toth, Ph.D., University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Vermont
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP