About this trial
Persons with COPD benefit from being physically active, but they are often limited by chronic musculoskeletal pain. This project will determine whether a non-pharmacologic, integrated, technology-mediated walking and Tai Chi mindfulness intervention can improve physical function in Veterans with COPD and chronic musculoskeletal pain. The proposed research addresses VA Rehabilitation R\&D Service's high priority area of improving health-related quality of life by reducing disease burden and maximizing function in Veterans with chronic disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female participants, aged 40 and older
Clinical diagnosis of COPD defined as history of cigarette consumption of > 10 pack-years, and either a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) < 0.70 or chest computerized tomography (CT) evidence of emphysema*
Numeric Rating Scale pain score > 3 for > 3 months
Self-reported ability to walk a minimum of one block, bend at the hip, and transfer weight from one leg to another
Disqualifiers
COPD exacerbation in the previous 1 month
Clinical signs of unstable cardiovascular disease (active coronary artery disease, congestive heart failure, uncontrolled atrial fibrillation, or uncontrolled hypertension)
Oxygen saturation < 85% recorded on baseline 4-meter walk*
High fall risk (unable to perform 5 chair stand tests)
Trial design
Parallel
Treatments tested in this trial
Every Step Counts-Tai Chi
BehavioralThe intervention is ESC-TC which is a web-based platform (Every Step Counts) to promote walking combined with pain management content, an online Tai Chi video library, and synchronous Tai Chi classes led by an instructor via teleconference. The intervention is delivered remotely.
Usual Care
Other interventionUsual Care
Treatment groups
Trial outcomes
Primary outcomes
Physical Function measured by Daily Step Counts
The FitBit pedometer will objectively-measure physical activity as daily step counts.
Secondary outcomes
Pain Intensity
The 11-point Numeric Rating Scale (0=no pain; 10=worst pain imaginable) will assess pain intensity.
Dyspnea
Dyspnea will be assessed using the mMRC scale (responses 0-4 with 4 being the most dyspneic).
Pain Interference
The Interference subscale of the West Haven-Yale Multidimensional Pain Inventory will assess pain-related interference, with higher scores representing greater interference.
Dyspnea
UCSD Shortness of Breath Questionnaire with 24 items. Scores range from 0 to 120.
Sponsors and contacts
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VA Office of Research and Development
Lead sponsor
University of Michigan
Collaborator
Beth Israel Deaconess Medical Center
Collaborator