N/A
N=9
BRAIN, Symptoms, and Physical Activity in COPD
COPD · Chronic Musculoskeletal Pain
Bottom Line
View on ClinicalTrials.gov: NCT04291131 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Cortical Thickness — 2.2 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cortical Thickness |
2.2 | — |
| SECONDARY Exercise Capacity |
1410 | — |
| SECONDARY Physical Activity |
4835 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Greater than or equal to 40 years of age
- Clinical diagnosis of COPD defined as either a ratio of FEV1 to forced vital capacity < 0.70 or chest CT evidence of emphysema or prior documentation of FEV1/FVC ratio of < 0.7 and clinical evidence of COPD (defined as 10 pack-year cigarette smoking history, dyspnea, or on bronchodilators)
- Will participate in a physical activity intervention or exercise program
- Competent to provide informed consent
- Willingness to make return visits and be available by telephone for duration of study
Exclusion Criteria
- Female sex
- Claustrophobia
- History of seizures
- Known brain lesion
- Current diagnosis of bipolar disorder, schizophrenia, or psychotic disorder
- Cognitive disorder such as dementia
- Known metal in body including:
- shrapnel
- surgical medical clips
- implants
- pacemakers
- metal-based tattoos
Data sourced from ClinicalTrials.gov (NCT04291131). 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.