Smart Telehealth Exercise Intervention to Reduce COPD Readmissions

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: Neuromuscular electrical stimulation (NMES)

• Registration Number: NCT03089853
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2016-07-14
• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Primary Completion: 2019-08-31
• Study Completion: 2020-08-15
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-09-01
• Results First Posted: 2020-09-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-18
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Neuromuscular electrical stimulation (NMES)	Subjects randomized to intervention arm will have a device applied to their thigh on either side, and subject to neuromuscular electrical stimulation for 30 minutes daily for 2 weeks, followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.

Primary Outcome Measures

Name	Time	Method
Rate of All-cause Readmissions	Up to Day 30	The primary outcome is the rate of all-cause readmissions within 30 days following an index hospitalization for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

Secondary Outcome Measures

Name	Time	Method
Change in COPD Related Quality of Life - COPD Assessment Test (CAT)	12 weeks	CAT is a self-administered questionnaire where a change of 2 units is considered clinically significant.
30-second Chair Test to Measure Skeletal Muscle Dysfunction, Leg Strength and Endurance	12 weeks	Scores range from 4 to 14, depending on age and sex. Higher scores indicate higher levels of functioning. MCID is 2.
Change in Dyspnea - San Diego Shortness of Breath Questionnaire (SOBQ)	12 weeks	SOBQ is a self-administered questionnaire to rate the level of dyspnea associated with activities of daily living. The minimum clinically important difference (MCID) if 5 units.
Changes in Muscle Inflammation	12 weeks	Pro-inflammatory signaling in quadriceps skeletal muscle
Change in Forced Expiratory Volume During First Second (FEV1)	12 weeks	This outcome will be measured using spirometry.
Change in Muscle Strength of Quadriceps	12 weeks	Measured using a dynamometer in pounds/kilograms.
Change in Dyspnea - Modified Medical Research Council (mMRC) Score	12 weeks	mMRC scale is a five-point scale originally published in 1959 that considers certain activities, such as walking or climbing stairs, which provoke breathlessness.
Changes in Systemic Inflammation	12 weeks	Blood levels of C-Reactive Protein (CRP), Fibrinogen, Interleukin 6 (IL-6) and Tumour Necrosis Factor alpha (TNF-alpha)

Trial Locations

Locations (1)

UAB Lung Health Center; 🇺🇸 Birmingham, Alabama, United States