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Principal Investigator: Franco Laghi
Organization: EDWARD HINES JR VA HOSPITAL
Fiscal Year: 2024
Funding agency: Veterans Affairs
Rationale: In COPD, hospital-based pulmonary rehabilitation can improve symptoms, functional status, and
quality of life and decrease unscheduled physician visits, emergency room visits, hospitalizations, and possibly,
mortality. Despite the well documented efficacy, hospital-based rehab remains inadequate due to insufficient
access, acceptance and sustainability. This has triggered a growing interest in home-based rehab programs.
Patients enrolled in home-based programs, however, may exercise at low intensities to avoid dyspnea/fatigue,
limiting the potential benefits of exercise training. Accordingly, it is essential to develop innovative home-based
programs that decrease exercise-induced dyspnea and fatigue while ensuring sufficient exercise intensity to
produce sustainable physiologic benefit. Recent data suggest that rhythmically enhanced stimulation (RAS)
using music may constitute such an innovative strategy. Music can diminish exercise-induced dyspnea/fatigue
allowing patients to tolerate more challenging physical activity and obtain a greater benefit from rehab. Music
also can induce entrainment of motor responses such as walking. We thus plan to capitalize on both the
sensorimotor coupling of gait with RAS-enhanced music and the mitigating effect of music over exercise-induced
dyspnea/fatigue. Specifically, we propose to compare the efficacy of a 12-week, home-based exercise program
augmented by patient-tailored, RAS-enhanced music to a 12-week traditional home-based exercise program in
patients with COPD. Hypothesis: (H1) Compared to patients randomized to a home-based, exercise program
without music (control group), patients randomized to a home-based, exercise program augmented with RAS-
enhanced music (intervention group) will demonstrate (H1a, primary hypothesis) greater increase in 6-minute
walk distance, (H1b) greater increase in walking time on a constant-load treadmill test protocol, (H1c) reduced
dyspnea during a constant-load treadmill test protocol, and (H1d) greater increases in health-related quality of
life. In addition (H2), they will accumulate greater volume of physical activity (actigraphy) and (H3) will better
sustain these benefits over time. Lastly (Explorative Objective), we will assess the mechanistic impact
physiological and psychological phenotype and clinical factors on responsiveness to rehabilitation (duration
constant-load treadmill test) achieved with and without concurrent use of RAS-music. Methods: The proposed
study is a randomized, controlled clinical trial in which 170 patients will be randomized into a home-based,
exercise program without music or a home-based exercise program augmented with RAS-enhanced music.
Patients will receive 12-weeks of home-based training per group assignment (at least three times weekly) followed
by 12-weeks of follow-up to assess the sustainability of our novel intervention. Testing will be carried out at
baseline and at 6, 12 and 24 weeks. Testing will include pulmonary function test, 6-minute walk tests, constant-
load treadmill test, physical activity quantification, measurements of dyspnea, quality of life, and objective
quantification of quadriceps dimensions (ultrasonography) and strength/fatigue (magnetic stimulation of the
femoral nerve). Analysis: In the principal analysis of the primary outcome measure (6-minute walk distance) we
will use a mixed-model analysis that includes treatment, time and treatment-by-time interaction terms. This
model will automatically account for missing data—where missing at random is assumed. We will conduct a
sensitivity analysis based on the results of the mixed model analysis to determine which other assumptions
regarding missing data might produce different results. One component of the sensitivity analysis will include
adjustment for baseline demographic and health covariates. A linear regression model and a mixed model
ANOVA will be used to assess the impact of clinical confounders (Explorative Objective). Scientific
contribution: These data will provide a solid foundation to determine the physiologic impact of our rehab
strategy. This innovative, practical and economical pulmonary rehabilitation strategy has the potential to create
a paradigm shift in the care of the many veterans with COPD who have no access to pulmonary rehabilitation.
Terms: <ANOVA><Acoustic Stimulation><Active Follow-up><Adherence><Analysis of Variance><Anxiety><Auditory Stimulation><Breathlessness><COPD><Caring><Chronic Obstruction Pulmonary Disease><Chronic Obstructive Lung Disease><Chronic Obstructive Pulmonary Disease><Clinic><Clinical><Control Groups><Coupling><Cyclicity><Data><Dimensions><Dyspnea><ED visit><ER visit><Echography><Echotomography><Eligibility><Eligibility Determination><Emergency care visit><Emergency department visit><Emergency hospital visit><Emergency room visit><Enrollment><Ensure><Equipment><Exercise><Exercise Tolerance><Exertion><Fatigue><Fear><Foundations><Fright><Gait><Health><Health Care Costs><Health Care Professional><Health Costs><Health Professional><Healthcare Costs><Healthcare professional><Home><Hospital Admission><Hospitalization><Hospitals><Impairment><Inpatients><Intervention><Intervention Strategies><Lack of Energy><Linear Regressions><Lung><Lung Function Tests><Lung Respiratory System><Magnetism><Measurement><Measures><Medical><Medical Rehabilitation><Medical Ultrasound><Mental Depression><Methods><Modeling><Motor><Music><Out-patients><Outcome Measure><Outpatients><Patients><Pattern><Periodicity><Peripheral arterial disease><Phenotype><Physical activity><Physically Challenged><Physicians><Physiologic><Physiological><Protocol><Protocol Screening><Protocols documentation><Psychological Factors><Pulmonary function tests><QOL><Qualifying><Quality of life><Randomized><Randomized Controlled Clinical Trials><Rehabilitation><Rehabilitation therapy><Rhythmicity><Self Efficacy><Severities><Solid><Symptoms><Testing><Time><Training><Transportation><Treadmill Tests><Ultrasonic Imaging><Ultrasonogram><Ultrasonography><Ultrasound Diagnosis><Ultrasound Medical Imaging><Ultrasound Test><Variance Analyses><Veterans><Visit><Walking><Work><actigraph><actigraphy><active followup><airflow limitation><airflow obstruction><airway limitation><airway obstruction><chronic obstructive pulmonary disorder><comparable efficacy><comparative efficacy><compare efficacy><cost><depression><determine efficacy><diagnostic ultrasound><disability><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><emotional reaction><enroll><evaluate efficacy><examine efficacy><exercise capacity><exercise intensity><exercise program><exercise training><experience><experimental group><femoral nerve><fitness program><follow up><follow-up><followed up><followup><functional gain><functional improvement><functional loss><functional status><group intervention><health related quality of life><homes><improve function><improve symptom><improved><improved functional outcomes><innovate><innovation><innovative><interest><interventional strategy><lung rehabilitation><magnetic><measurable outcome><mortality><novel><obstructed airflow><obstructed airway><outcome measurement><participant enrollment><patient enrollment><peripheral artery disease><primary outcome><programs><psychologic><psychological><pulmonary><pulmonary rehabilitation><quadriceps><quadriceps muscle><randomisation><randomization><randomized control clinical trial><randomly assigned><recruit><rehab strategy><rehab therapy><rehabilitation strategy><rehabilitative><rehabilitative therapy><respiratory airway obstruction><response><social><sonogram><sonography><sound measurement><success><symptom improvement><symptomatic improvement><systemic inflammation><systemic inflammatory response><ultrasound imaging><ultrasound scanning><walking pace><walking speed>