Increasing Physical Activity in COPD Through Rhythmically Enhanced Music
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 12/19/2018 |
| Start Date: | October 1, 2018 |
| End Date: | September 30, 2022 |
| Contact: | Susan A O'Connell Schnell, RN MHA |
| Email: | susan.oconnell@va.gov |
| Phone: | (708) 202-7817 |
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.
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.
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
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
Inclusion Criteria:
- FEV1 70%
- FEV1/FVC <70%
- Mean SpO2 88% at peak exercise (with or without oxygen supplementation)
- Ability to hear music
Exclusion Criteria:
- 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
We found this trial at
1
site
Hines, Illinois 60141
Principal Investigator: Franco Laghi, MD
Phone: 708-202-7817
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