Transitional Rehabilitation in CABG Patients

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Coronary Artery Bypass Graft Surgery
• Interventions: Device: neuromuscular electrical stimulation

• Registration Number: NCT03892460
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Primary Completion: 2019-10-24
• Study Completion: 2019-10-24
• Results First Submitted: 2021-04-28
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-10
• Last Update Submitted: 2021-07-10
• Results First Posted: 2021-08-03
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 50-80 yrs of age
• ambulatory
• scheduled for coronary artery bypass graft surgery
• able to provide informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	neuromuscular electrical stimulation	Neuromuscular electrical stimulation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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 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 - 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	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 - 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.
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.
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.

Trial Locations

Locations (1)

University of Vermont College of Medicine; 🇺🇸 Burlington, Vermont, United States