Clinical trial NCT03089853: Smart Telehealth Exercise Intervention to Reduce COPD Readmissions
Official title: Smart Telehealth Exercise Intervention to Reduce COPD Readmissions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
pulmonary rehabilitation
telehealth
smart
technology
Neuromuscular Electrical Stimulation (NEMS)
acute exacerbation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2017-03-24
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pilot, randomized controlled study where subjects will be randomized in a 2:1 ratio to either receive remote tele pulmonary rehabilitation intervention and NMES or usual care.
Primary purpose: TREATMENT

Brief summary: 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 the University of Alabama at Birmingham (UAB), about 30 will get Smart Telehealth and NMES, and 10 will get usual care.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of All-cause Readmissions
timeFrame: Up to Day 30
Secondary outcomes:
measure: Change in Forced Expiratory Volume During First Second (FEV1)
timeFrame: 12 weeks
measure: Change in Dyspnea - Modified Medical Research Council (mMRC) Score
timeFrame: 12 weeks
measure: Change in Dyspnea - San Diego Shortness of Breath Questionnaire (SOBQ)
timeFrame: 12 weeks
measure: Change in COPD Related Quality of Life - COPD Assessment Test (CAT)
timeFrame: 12 weeks
measure: Change in Muscle Strength of Quadriceps
timeFrame: 12 weeks
measure: 30-second Chair Test to Measure Skeletal Muscle Dysfunction, Leg Strength and Endurance
timeFrame: 12 weeks
measure: Changes in Systemic Inflammation
timeFrame: 12 weeks
measure: Changes in Muscle Inflammation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Lung Health Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Surya P Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
References: