Clinical trial NCT03892460: Transitional Rehabilitation in CABG Patients
Official title: Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Bypass Graft Surgery
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: 4 weeks
Secondary outcomes:
measure: 6 Minute Walk Distance
timeFrame: 4 weeks
measure: Medical Outcomes Short Form 36 - Physical Function
timeFrame: Hospital discharge and 4-weeks post-discharge
measure: Medical Outcome Short Form 36 - Role Physical
timeFrame: Hospital discharge and 4-weeks post-discharge
measure: Medical Outcomes Short Form 36 - Bodily Pain
timeFrame: Hospital discharge and 4-week post-discharge
measure: Medical Outcomes Short Form 36 - General Health
timeFrame: Hospital discharge and 4-week post-discharge
measure: Medical Outcomes Short Form 36 - Vitality
timeFrame: Hospital discharge and 4-weeks post-discharge
measure: Medical Outcomes Short Form 36 - Social Function
timeFrame: Hospital discharge and 4-weeks post-discharge
measure: Medical Outcomes Short Form 36 - Role Emotional
timeFrame: Hospital discharge and 4-week discharge
measure: Medical Outcomes Short Form 36
timeFrame: Hospital discharge and 4-week post-discharge
measure: Physical Activity
timeFrame: Daily from discharge to 4-week post-discharge evaluation
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
Study officials:
References:
citation: 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.