NCT03655028Completed
Increasing Physical Activity in COPD Through Rhythmically Enhanced Music
Source: ClinicalTrials.gov · Last updated 17 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 93 (actual)
- First submitted
- 29 Aug 2018
- Start date
- 1 Oct 2018
- Primary completion date
- 11 Sept 2023
- Lead sponsor
- VA Office of Research and Development
- Diseases
- COPD
- NCT number
- NCT03655028
What you commit to
- Study type: Interventional
- Participants enrolled: 93
- From 1 Oct 2018 to the primary completion date, 11 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Respiratory infection/COPD exacerbation within the previous four weeks
- Participation in a formal exercise program within the previous 12-weeks
- COVID patients:
Other illness
- 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
- Any unforeseen illness or disability that would preclude exercise testing or training
- 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)
Other
- COPD patients:
- Stops exercise for arthritic pain in knee or hips
- Inability to walk on the treadmill
- Able to walk more than 550 meters during a standard 6-minute walk test
- Stops exercise due to arthritic pain in the knee or hips (self-report)
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL Coordinator of this site? Confirm its status | Hines | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.