An observational study in COPD and Chronic Musculoskeletal Pain, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by VA Office of Research and Development · Observational
Persons with COPD have both chronic musculoskeletal pain and dyspnea that require accurate diagnosis and treatment, ultimately to optimize functional status. The investigators propose to use advanced neuroimaging techniques to understand central mechanisms of chronic pain, dyspnea, and physical activity promotion in COPD. The investigators' novel proposal to correlate subjective symptoms (chronic pain and dyspnea) with an objective central biomarker (resting state functional connectivity) and examine their changes in response to a non-pharmacological, non-addictive physical activity intervention will personalize the care of Veterans with COPD.
COPD is the nation's third leading cause of death and affects up to 11% of all VA healthcare patients. Patients with COPD experience significant dyspnea despite optimization of medical therapy. In addition, over half of patients with COPD experience chronic pain--largely musculoskeletal pain. Clinically, in patients who suffer from both chronic pain and dyspnea, it is difficult to distinguish a patient's perception of one symptom modulated by the other. Novel objective diagnostic tools are needed to complement patient self-report and accurately distinguish symptoms in patients who have both chronic pain and dyspnea to optimize clinical management. It is also important to study chronic pain and dyspnea in COPD because they are common barriers to engaging in physical activity (PA) and exercise. The clinical course of COPD is characterized by a downward spiral of dyspnea and chronic pain, physical inactivity, and significant functional limitation. Although chronic pain and dyspnea can be barriers, PA and exercise are powerful, but underused, non-addictive therapies for management of these symptoms in COPD. The investigators developed Every Step Counts (ESC), a technology-mediated intervention based on the Theory of Self-Regulation, to promote PA in COPD. The investigators have demonstrated ESC's safety, feasibility, and efficacy to increase PA and improve health-related quality of life in Veterans with COPD. In two separate studies using questionnaires, ESC has been shown to improve dyspnea in COPD and relieve chronic back pain in Veterans. An important next step is to understand the mechanisms of benefit of PA interventions, like ESC, in the many COPD patients with both chronic musculoskeletal pain and dyspnea to ultimately design better PA interventions and optimize treatment of these symptoms. Currently, the central mechanisms of chronic pain and dyspnea, and how they change in response to PA promotion in COPD are largely unknown. It has been shown that pre-stimulus resting state functional connectivity determines pain perception in healthy humans. Resting state fcMRI evaluates interactions between brain regions before a sensory event or when an explicit task is not being performed. These communications are altered in older adults with chronic musculoskeletal pain. Functional connectivity among regions specifically within the "default mode" network (DMN) (posterior cingulate, inferior parietal lobes, and medial frontal gyrus) have been examined in clinical disease states, as this network is reliably detected and well-characterized. Functional connectivity may be a novel biomarker of chronic pain and dyspnea.
Aim 1: Characterize and correlate the relationship between functional connectivity and chronic musculoskeletal pain and dyspnea in 30 persons with COPD (10 with both symptoms, 10 with chronic pain, and 10 with dyspnea).
Aim 2: Explore changes in functional connectivity and changes in symptoms in 30 persons with COPD after use of the ESC intervention to increase PA.
The investigators' proposed design will leverage enrollment of well-characterized participants with COPD already using the ESC PA intervention as part of a distinct and ongoing RR\&D Merit Award. This proposal will provide insight into the biologically complex relationships between symptoms (chronic pain and dyspnea), behavior (PA), and biology at the central level (functional connectivity).
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 9 is below the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Veterans with COPD
Exclusion Criteria:
Known metal in body including:
Veterans with COPD who will participate in a physical activity intervention or exercise program
Cortical Thickness
Cortical thickness will be measured by brain MRIs that will assess functional connectivity and structural variables. Cortical thickness will be reported in millimeters.
Time frame: 3 months
Exercise Capacity
measured by the 6-minute walk test
Time frame: 3 months
Physical Activity
Measured by daily step counts
Time frame: 3 months
Pain Intensity
Pain intensity will be measured with the Brief Pain Index. The Brief Pain Index rates pain intensity on a numbered scale of 0 - 10, with higher scores indicating more pain.
Time frame: 3 months
Dyspnea
Dyspnea will be measured with the modified Medical Research Council scale from 0 to 4 where a higher score means greater dyspnea.
Time frame: 3 months
| Milestone | Veterans With COPD |
|---|---|
| Started | 9 |
| Completed | 6 |
| Not completed | 3 |
Cortical thickness will be measured by brain MRIs that will assess functional connectivity and structural variables. Cortical thickness will be reported in millimeters.
| mm | Veterans With COPD |
|---|---|
| Cortical Thickness | 2.2 ± 0.06 |
measured by the 6-minute walk test
| feet | Veterans With COPD |
|---|---|
| Exercise Capacity | 1410 ± 80 |
Measured by daily step counts
| steps per day | Veterans With COPD |
|---|---|
| Physical Activity | 4835 ± 3226 |
Pain intensity will be measured with the Brief Pain Index. The Brief Pain Index rates pain intensity on a numbered scale of 0 - 10, with higher scores indicating more pain.
| units on a scale | Veterans With COPD |
|---|---|
| Pain Intensity | 4 ± 1.41 |
Dyspnea will be measured with the modified Medical Research Council scale from 0 to 4 where a higher score means greater dyspnea.
| units on a scale | Veterans With COPD |
|---|---|
| Dyspnea | 1.83 ± 1.47 |
Collected over Duration of the study from enrollment to follow-up of approximately 3 months for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Veterans With COPD | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Veterans With COPD |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 7 |
| Age, Continuous(years) | Veterans With COPD |
|---|---|
| Mean | 73 ± 6 |
| Sex: Female, Male(Participants) | Veterans With COPD |
|---|---|
| Female | 0 |
| Male | 9 |
| Race (NIH/OMB)(Participants) | Veterans With COPD |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Veterans With COPD |
|---|---|
| United States | 9 |
| Cortical thickness(mm) | Veterans With COPD |
|---|---|
| Mean | 2.24 ± 0.1 |
| Pain(units on a scale) | Veterans With COPD |
|---|---|
| Mean | 4 ± 3 |
| Dyspnea(units on a scale) | Veterans With COPD |
|---|---|
| Mean | 2.38 ± 1.3 |
2 further baseline measures are reported on the registry.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
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