CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Neuromuscular electrical stimulation (NMES)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03089853
NCT03089853N/ACompleted

Smart Telehealth Exercise Intervention to Reduce COPD Readmissions

University of Alabama at Birmingham·interventional·Posted Mar 24, 2017·Updated Mar 22, 2022

In Brief

A clinical study evaluating Neuromuscular electrical stimulation (NMES) for Chronic Obstructive Pulmonary Disease. Completed, enrolled 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 24, 2017
Enrollment StartJul 14, 2016
Primary CompletionAug 31, 2019
Study CompletionAug 15, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.3 years ago

Interventions

Neuromuscular electrical stimulation (NMES)device

Bipolar self-adhesive neuromuscular stimulation electrodes will be placed over the quadriceps femoris muscle group. Stimulation pulses (30 Hz trains of 300 μsec biphasic pulses) will be delivered using the neuromuscular electrical stimulator. A 5 sec on/25 sec off work/rest ratio will be used initially, progressing to 10 sec on/30 sec off. The patient will be fully supported while knee extensions are performed as the participant sits in a chair. Current from the stimulator will be manually increased and determined by patient tolerance. The goal for each patient will be to reach the highest tolerable amplitude (up to 100mA). Training will be performed on each quadriceps femoris muscle, 30 minutes/day, for 2 weeks including hospital stay till return to the COPD Clinic. This will be 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.