NCT03892460

Transitional Rehabilitation in CABG Patients

Completed NA Results posted Last updated 3 August 2021

What this trial tests

NA trial testing neuromuscular electrical stimulation in Coronary Artery Disease in 54 participants. Completed in 24 October 2019.

Timeline

1 September 2017

Primary endpoint
24 October 2019

24 October 2019

Quick facts

Lead sponsor	University of Vermont
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	54
Start date	1 September 2017
Primary completion	24 October 2019
Estimated completion	24 October 2019
Sites	1 location across United States

Drugs / interventions tested

• neuromuscular electrical stimulation

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Coronary Artery Bypass Graft Surgery — all drugs for Coronary Artery Bypass Graft Surgery →

Sponsor

University of Vermont

Who can join

Adults 50 to 80, any sex, with Coronary Artery Disease or Coronary Artery Bypass Graft Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Short Physical Performance Battery Primary · 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.

Discharge

Group	Value	95% CI
Treatment	7.33	± 0.55
Control	8.00	± 0.54

4-weeks post-discharge

Group	Value	95% CI
Treatment	11.44	± 0.22
Control	10.90	± 0.21

6 Minute Walk Distance Secondary · 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.

Discharge

Group	Value	95% CI
Treatment	216	± 22
Control	238	± 21

4-weeks post-discharge

Group	Value	95% CI
Treatment	482	± 21
Control	431	± 20

Medical Outcomes Short Form 36 - Physical Function Secondary · 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 disabilit

Discharge

Group	Value	95% CI
Treatment	40	± 7
Control	33	± 7

4-weeks post-discharge

Group	Value	95% CI
Treatment	70	± 5
Control	58	± 5

Medical Outcome Short Form 36 - Role Physical Secondary · 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

Discharge

Group	Value	95% CI
Treatment	26	± 10
Control	21	± 9

4-weeks post-discharge

Group	Value	95% CI
Treatment	19	± 8
Control	18	± 7

Medical Outcomes Short Form 36 - Bodily Pain Secondary · 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.

Discharge

Group	Value	95% CI
Treatment	31	± 4
Control	28	± 4

4-weeks post-discharge

Group	Value	95% CI
Treatment	28	± 3
Control	27	± 3

Medical Outcomes Short Form 36 - General Health Secondary · 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.

Discharge

Group	Value	95% CI
Treatment	71	± 4
Control	63	± 4

4-weeks post-discharge

Group	Value	95% CI
Treatment	81	± 3
Control	72	± 3

Medical Outcomes Short Form 36 - Vitality Secondary · 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.

Discharge

Group	Value	95% CI
Treatment	55	± 5
Control	53	± 5

4-weeks post-discharge

Group	Value	95% CI
Treatment	55	± 4
Control	51	± 3

Medical Outcomes Short Form 36 - Social Function Secondary · 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 lm

Discharge

Group	Value	95% CI
Treatment	74	± 7
Control	63	± 7

4-week post-discharge

Group	Value	95% CI
Treatment	76	± 6
Control	72	± 5

Medical Outcomes Short Form 36 - Role Emotional Secondary · 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.

Discharge

Group	Value	95% CI
Treatment	65	± 11
Control	54	± 11

4-week post-discharge

Group	Value	95% CI
Treatment	72	± 10
Control	51	± 9

Medical Outcomes Short Form 36 Secondary · 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.

Discharge

Group	Value	95% CI
Treatment	77	± 4
Control	74	± 4

4-week post-discharge

Group	Value	95% CI
Treatment	86	± 4
Control	78	± 3

Physical Activity Secondary · 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).

Group	Value	95% CI
Treatment	125.6
Control	109.6

Adverse events — posted to ClinicalTrials.gov

Time frame: 1-month post-surgery. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment

Serious: 0/30 (0%)

Deaths: 0/30

Control

Serious: 0/24 (0%)

Deaths: 0/24

Other adverse events (1 terms — click to expand)

Reaction	System	Treatment	Control
Pleuritic chest pain	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT03892460 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Improvement in Physical Function After Coronary Artery Bypass Graft Surgery Using a Novel Rehabilitation Intervention: A RANDOMIZED CONTROLLED TRIAL.
   Rengo JL, Savage PD, Hirashima F, Leavitt BJ, et al · · 2021 · cited 7× · PMID 33512980 · DOI 10.1097/hcr.0000000000000576
2. Assessment of the Early Disabling Effects of Coronary Artery Bypass Graft Surgery Using Direct Measures of Physical Function.
   Rengo JL, Savage PD, Hirashima F, Leavitt BJ, et al · · 2022 · cited 6× · PMID 33797459 · DOI 10.1097/hcr.0000000000000587