Clinical trial NCT03655028: Increasing Physical Activity in COPD Through Rhythmically Enhanced Music
Official title: Increasing Physical Activity in COPD Through Rhythmically Enhanced Music
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD Patients and Patients Recovering From COVID19
Keywords: COPD
Exercise
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-08-31
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial in which COPD patients in the intervention group and COVID19 patient in the intervention group will undergo a home-based, exercise program augmented with RAS-enhanced music while COPD patients in the control group and COVID19 patients in the control group will undergo a home-based, exercise program without music. Outcomes of the home-based exercise program with music will be compared to the outcomes of home-based exercise alone. Outcomes are listed below.
Primary purpose: TREATMENT

Brief summary: The VA cares for nearly one million Veterans with COPD at a cost of more than $5.5 billion annually. COPD profoundly impairs quality of life as it limits ability to work, to maintain physical exertion and to engage in social activities. Hospital-based rehab can decrease the need for inpatient and outpatient medical care and can improve exercise capacity, quality of life and, possibly, decrease mortality. Unfortunately, access to hospital-based VA rehab is insufficient and, over time, the few Veterans who attend experience progressive loss of functional gains. The investigators reason that the proposed home-based exercise program augmented by patient-tailored, RAS-enhanced music will overcome the many limitations of hospital-based rehab. Through this innovative program, the investigators expect to enhance the benefits of rehab and better maintain them over time. The easy applicability of this innovative, accessible and economical program has the potential to modify the spiraling pattern of increasing disability and reduce health-care cost and mortality in Veterans with COPD.

In 2021, the investigators obtained an 'Administrative Project Modification' to the parent COPD study in which they will include patients recovering from prolonged COVID19 hospitalization. Specifically, the investigators will use the novel RAS-enhanced music exercise program developed for the parent grant in patients recovering from COVID19. The main goal of the modified proposal for COVID19 patients will be to compare the efficacy of a 12-week, home-based exercise program augmented by RAS-therapeutic music and strength training to 12-weeks usual care and strength training in patients recovering from COVID 19.

Detailed description: 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 auditory 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. The investigators 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, the investigators 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), the investigators 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 the investigators' 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) the investigators 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. The investigators 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 the 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. The above-described protocol will be also tested in patients recovering form COVID19. The investigators reason that the proposed innovative, practical, safe and economical program has the potential to create a paradigm shift in the care of the many veterans who were hospitalized with COVID19 and who have no access to physical rehabilitation.

Please note: Due to the COVID-19 pandemic, constant load treadmill testing could not be completed as was originally proposed. There was concern that COVID-19 could be transmitted due to increased exposure to increased saliva associated with testing. Therefore, the objectives using constant load testing will not be reported. The exploratory objective was based on the constant workload treadmill test so that is not reported. Additionally, again due to the COVID-19 pandemic, 6-week testing was not completed after the pandemic due to the increased risk of transmission (n.b., 6-week data were not included in the outcomes and was to be used for analysis of the primary objective; as such, the analysis of the primary objective was changed to ANCOVA from what was in the protocol). The protocol attached here is the last approved IRB protocol and includes both patients with COPD and COVID. Only data on patients with COPD are reported here. The two groups of patients were two different populations and it does not make theoretical sense to combine the data at this point. Text concerning COVID are in gray.

Eligibility criteria: Inclusion Criteria:

COPD patients:

* =\< 40 yr. of age
* FEV1 =\< 70%
* FEV1/FVC \<70%
* Mean SpO2 88% at peak exercise (with or without oxygen supplementation)

COVID19 patients

* \>=18 yrs. of age
* Previous hospital and/or emergency room visit for laboratory-confirmed COVID-19 diagnosis.
* Able to walk independently
* Mean SpO2 88% at peak exercise (with or without oxygen supplementation)
* Ability to hear music

Exclusion Criteria:

COPD patients:

* Respiratory infection/COPD exacerbation within the previous four weeks
* Exercise-limiting heart disease

  * Congestive heart failure - i.e., New York Heart Association Class III or IV
  * Positive stress test or other indicators of heart disease or complaints of angina during the stress test
* Exercise-limiting peripheral arterial disease

  * Stops walking due to intermittent claudication
* Stops exercise for arthritic pain in knee or hips
* Inability to walk on the treadmill
* Any unforeseen illness or disability that would preclude exercise testing or training
* Participation in a formal exercise program within the previous 12-weeks

COVID patients:

* Able to walk more than 550 meters during a standard 6-minute walk test
* Exercise limiting heart disease

  * Complaints of angina during the 6- minute walk distance tests or other indicators of exercise-limiting heart disease
* Congestive heart failure (New York Heart Association Class III or IV)
* Exercise-limiting peripheral arterial disease (stops exercise due to intermittent claudication)
* Stops exercise due to arthritic pain in the knee or hips (self-report)
* Pregnancy

Primary outcomes:
measure: Six-minute Walk Distance
timeFrame: 12 weeks
Secondary outcomes:
measure: Volume of Daily Physical Activity
timeFrame: 12 weeks
measure: Six-minute Walk Distance
timeFrame: 24 weeks
measure: Quality of Life Physical Function
timeFrame: 12 weeks
measure: Quality of Life Mental Health
timeFrame: 12-weeks
Other outcomes:
measure: Adherence to Training Sessions Protocol
timeFrame: 12 weeks
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Franco Laghi, MD
role: PRINCIPAL_INVESTIGATOR
References: