NCT03892460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

August 3, 2021

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

March 26, 2019

Results QC Date

April 28, 2021

Last Update Submit

July 10, 2021

Conditions

Coronary Artery DiseaseCoronary Artery Bypass Graft Surgery

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery

    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.

    4 weeks

Secondary Outcomes (10)

  • 6 Minute Walk Distance

    4 weeks

  • Medical Outcomes Short Form 36 - Physical Function

    Hospital discharge and 4-weeks post-discharge

  • Medical Outcome Short Form 36 - Role Physical

    Hospital discharge and 4-weeks post-discharge

  • Medical Outcomes Short Form 36 - Bodily Pain

    Hospital discharge and 4-week post-discharge

  • Medical Outcomes Short Form 36 - General Health

    Hospital discharge and 4-week post-discharge

  • +5 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Neuromuscular electrical stimulation

Device: neuromuscular electrical stimulation

Control

NO INTERVENTION

No treatment control

Interventions

neuromuscular electrical stimulationDEVICE

bilateral quadriceps exercise with neuromuscular electrical stimulation

Treatment

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

  • 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.

    PMID: 33512980DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Limitations and Caveats

First, patients were not blinded to treatment status because NMES elicits skeletal muscle contraction and any sham treatment would not. Second, study personnel were not blinded, as resources were insufficient for unblinded and blinded personnel. Third, we did not analyze data using an intent-to-treat approach. Fourth, our study included few women. Finally, our study is limited to the strict inclusion/exclusion criteria and studies in larger cohorts are required to assess external validity.

Results Point of Contact

Title
Michael Toth
Organization
University of Vermont College of Medicine
michael.toth@med.uvm.edu
802-656-7989

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 27, 2019

Study Start

September 1, 2017

Primary Completion

October 24, 2019

Study Completion

October 24, 2019

Last Updated

August 3, 2021

Results First Posted

August 3, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)