Smart Telehealth Exercise Intervention to Reduce COPD Readmissions



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:5/12/2018
Start Date:July 14, 2016
End Date:July 2019
Contact:Surya P Bhatt, MD
Email:sbhatt@uabmc.edu
Phone:(205) 934-5555

Use our guide to learn which trials are right for you!

This is a prospective randomized controlled study to test the hypothesis that neuromuscular
electrical stimulation (NMES) and remote pulmonary rehabilitation at home offered via a smart
technology, called Smart TeleHealth, results in a reduction of systemic inflammation, via
reduction of skeletal muscle tissue inflammation, and thereby improves functional capacity,
and thus, reduces the rate of readmissions following hospitalization for acute exacerbations
of Chronic Obstructive Pulmonary Disease (COPD). This study will enroll up to 40 participants
at UAB, about 30 will get Smart Telehealth and NMES, and 10 will get usual care.

The overall hypothesis of our proposal is that neuromuscular electrical stimulation (NMES)
and remote pulmonary rehabilitation at home offered via smart technology results in a
reduction of systemic inflammation, via reduction of skeletal muscle tissue inflammation, and
thereby improves functional capacity, and thus, reduces the rate of readmissions following
hospitalization for acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD.) We
propose the following specific aims:

Aim 1: To determine if an NMES and remote tele pulmonary rehabilitation intervention reduces
30-day all cause readmissions in patients hospitalized for acute exacerbation of COPD.
Skeletal muscle dysfunction is associated with the number of hospital admissions, duration of
hospital stay and total number of exacerbations. We and others have shown that applying NMES
results in significant improvements in quadriceps muscle strength. It is plausible that
targeting skeletal muscle dysfunction will result in improved respiratory outcomes. Based on
our preliminary results comparing our exercise intervention with historic data, we
hypothesize that a combination of early in-hospital and home NMES and home pulmonary
rehabilitation using smart technology will prevent hospital readmissions following an acute
exacerbation of COPD.

Aim 2: To evaluate the effects of an NMES and remote tele pulmonary rehabilitation
intervention on muscle strength, dyspnea and respiratory quality of life in COPD post
hospital discharge. Skeletal muscle dysfunction contributes to the morbidity associated with
acute exacerbations, results in a longer duration of hospital stay and a shorter time to
readmission, and is associated with more frequent exacerbations. We hypothesize that by
preventing deconditioning, improving muscle bioenergetics and positively affecting muscle
strength, NMES and home pulmonary rehabilitation will improve respiratory quality of life,
dyspnea and functional capacity. We will compare outcome measures for respiratory morbidity
at baseline with those at 12 weeks.

Aim 3: To evaluate the effects of NMES and remote tele pulmonary rehabilitation intervention
on systemic and muscle inflammation. Acute exacerbations of COPD are associated with
sustained systemic inflammation and the mechanism for this may be perpetuation of
inflammation by a skeletal muscle reservoir. We have previously shown that older patients
such as those with COPD are more susceptible to muscle inflammation. Based on our preliminary
results showing significant benefits, we hypothesize that the reduced readmission rates are a
direct effect of lowering muscle inflammation. We hypothesize that inflammation arising from
the lungs is perpetuated by pro-inflammatory signaling in the skeletal muscles that sustains
systemic inflammation, and this can be reduced by a combination of early NMES and exercise
therapy at home by reducing skeletal muscle production of pro-inflammatory cytokines. We will
perform quadriceps muscle biopsy at baseline and at 4 weeks to demonstrate reduction in
pro-inflammatory signaling in skeletal muscles at 4 weeks in the intervention arm and
anticipate that this reduction will be associated with reduction in systemic inflammation.

Inclusion Criteria:

- Subjects who are hospitalized with an acute exacerbation of COPD and can be enrolled
within 36 hours of hospitalization.

- Age 40 years or older.

Exclusion Criteria:

- Secondary diagnosis of congestive heart failure and other respiratory conditions that
could confound the diagnosis such as pneumonia, bronchiectasis and lung cancer will be
excluded.

- Those on invasive or mechanical ventilation will not be enrolled.

- Participants with pacemakers/defibrillators will not be enrolled due to concern for
interaction with NEMS.

- Inability to consent for themselves.

- Pregnant or breastfeeding women will be excluded to minimize the risks of
neuromuscular electrical stimulation.
We found this trial at
1
site
Birmingham, Alabama 35294
Phone: 205-934-5555
?
mi
from
Birmingham, AL
Click here to add this to my saved trials