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N/A N=93 Randomized Double-blind Treatment

Increasing Physical Activity in COPD Through Rhythmically Enhanced Music

COPD Patients and Patients Recovering From COVID19

Enrolled (actual)
93
Serious AEs
7.5%
Results posted
Mar 2025
Primary outcome: Primary: Six-minute Walk Distance — 452; 429 meters — p=0.85

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
rhythmically auditory stimulation enhanced music (Behavioral); control (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Sep 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Six-minute Walk Distance
444; 439 0.106
SECONDARY
Volume of Daily Physical Activity
3930; 3738 .307
SECONDARY
Six-minute Walk Distance
444; 439 0.106
SECONDARY
Quality of Life Physical Function
40.4; 38.7 0.26
SECONDARY
Quality of Life Mental Health
42.8; 42.3 0.85

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.

Eligibility Criteria

Inclusion Criteria

COPD 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03655028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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