N/A
Completed N=7
Smart Telehealth Exercise Intervention to Reduce COPD Readmissions
Source: ClinicalTrials.gov NCT03089853 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Rate of All-cause Readmissions — 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of All-cause Readmissions |
0; 0 | — |
| SECONDARY Change in Forced Expiratory Volume During First Second (FEV1) |
— | — |
| SECONDARY Change in Dyspnea - Modified Medical Research Council (mMRC) Score |
— | — |
| SECONDARY Change in Dyspnea - San Diego Shortness of Breath Questionnaire (SOBQ) |
— | — |
| SECONDARY Change in COPD Related Quality of Life - COPD Assessment Test (CAT) |
— | — |
| SECONDARY Change in Muscle Strength of Quadriceps |
— | — |
| SECONDARY 30-second Chair Test to Measure Skeletal Muscle Dysfunction, Leg Strength and Endurance |
— | — |
| SECONDARY Changes in Systemic Inflammation |
— | — |
| SECONDARY Changes in Muscle 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.
Data sourced from ClinicalTrials.gov (NCT03089853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.