Smart Telehealth Exercise Intervention to Reduce COPD Readmissions

NCT03089853 | Completed Results DMC FDA Device

• 1 other identifier: F160504003
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; pulmonary rehabilitation; telehealth; smart; technology; Neuromuscular Electrical Stimulation (NEMS); acute exacerbation

Outcome Measures

Primary Outcomes (1)

• Rate of All-cause Readmissions

  The primary outcome is the rate of all-cause readmissions within 30 days following an index hospitalization for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

  Up to Day 30

Secondary Outcomes (8)

• Change in Forced Expiratory Volume During First Second (FEV1)

  12 weeks

• Change in Dyspnea - Modified Medical Research Council (mMRC) Score

  12 weeks

• Change in Dyspnea - San Diego Shortness of Breath Questionnaire (SOBQ)

  12 weeks

• Change in COPD Related Quality of Life - COPD Assessment Test (CAT)

  12 weeks

• Change in Muscle Strength of Quadriceps

  12 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Device: Neuromuscular electrical stimulation (NMES)

Usual Care Arm

NO INTERVENTION

Usual care will consist of a protocolized regimen of 5 days of systemic steroids, unless the treating physician determines a different regimen, in which case the change will be documented.

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.

Also known as: Respond II neuromuscular electrical stimulator

Intervention Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are hospitalized with an acute exacerbation of COPD and can be enrolled within 36 hours of hospitalization.
• Age 40 years or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UAB Lung Health Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Small sample size.

Results Point of Contact

• Title: Surya P Bhatt
• Organization: University of Alabama at Birmingham

sbhatt@uabmc.edu

205-934-5555

Study Officials

• Surya P Bhatt, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 24, 2017
• Study Start: July 14, 2016
• Primary Completion: August 31, 2019
• Study Completion: August 15, 2020
• Last Updated: March 22, 2022
• Results First Posted: September 22, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)