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Smart Telehealth Exercise Intervention to Reduce COPD Readmissions

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ClinicalTrials.gov Identifier: NCT03089853
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Surya P Bhatt, 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 UAB, about 30 will get Smart Telehealth and NMES, and 10 will get usual care.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Neuromuscular electrical stimulation (NMES) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smart Telehealth Exercise Intervention to Reduce COPD Readmissions
Actual Study Start Date : July 14, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm
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)
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.
Other Name: Respond II neuromuscular electrical stimulator

No Intervention: Usual Care Arm
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.



Primary Outcome Measures :
  1. Rate of all-cause readmissions [ Time Frame: Up to Day 30 ]
    The primary outcome is the rate of all-cause readmissions within 30 days following an index hospitalization for COPD exacerbation.


Secondary Outcome Measures :
  1. Change in FEV1 [ Time Frame: 12 weeks ]
    This outcome will be measured using spirometry.

  2. Change in dyspnea - Modified Medical Research Council (mMRC) score [ Time Frame: 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.

  3. Change in dyspnea - San Diego Shortness of Breath Questionnaire (SOBQ) [ Time Frame: 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.

  4. Change in COPD related quality of life - COPD Assessment Test (CAT) [ Time Frame: 12 weeks ]
    CAT is a self-administered questionnaire where a change of 2 units is considered clinically significant.

  5. Change in muscle strength of quadriceps [ Time Frame: 12 weeks ]
    Measured using a dynamometer in pounds/kilograms.

  6. 30-second chair test to measure skeletal muscle dysfunction, leg strength and endurance [ Time Frame: 12 weeks ]
    Scores range from 4 to 14, depending on age and sex. Higher scores indicate higher levels of functioning. MCID is 2.

  7. Changes in systemic inflammation [ Time Frame: 12 weeks ]
    Blood levels of CRP, Fibrinogen, IL-6 and TNF-alpha

  8. Changes in muscle inflammation [ Time Frame: 12 weeks ]
    Pro-inflammatory signaling in quadriceps skeletal muscle



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089853


Contacts
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Contact: Surya P Bhatt, MD (205) 934-5555 sbhatt@uabmc.edu

Locations
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United States, Alabama
UAB Lung Health Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Surya P Bhatt, MD    205-934-5555    sbhatt@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Surya P Bhatt, MD University of Alabama at Birmingham

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Responsible Party: Surya P Bhatt, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03089853     History of Changes
Other Study ID Numbers: F160504003
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Surya P Bhatt, University of Alabama at Birmingham:
COPD
pulmonary rehabilitation
telehealth
smart
technology
NEMS
acute exacerbation

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases