Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-25 @ 6:34 PM
Study NCT ID:
NCT03892460
Status:
COMPLETED
Last Update Posted:
2021-08-03
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transitional Rehabilitation in CABG Patients
Sponsor:
University of Vermont
Organization:
Study Overview
Official Title:
Novel Transitional Rehabilitation Care in Coronary Artery Bypass Graft (CABG) Patients
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: