BRAIN, Symptoms, and Physical Activity in COPD

NCT04291131 | Completed Results

• 1 other identifier: F3305-P
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Chronic Musculoskeletal Pain

Keywords

COPD; Pain; Dyspnea; Neuroimaging; Functional Connectivity

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Exercise Capacity

  3 months

• Physical Activity

  3 months

Other Outcomes (2)

• Pain Intensity

  3 months

• Dyspnea

  3 months

Study Arms (1)

Veterans with COPD

Veterans with COPD who will participate in a physical activity intervention or exercise program

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans with COPD

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

Biospecimen

Retention: NONE RETAINED

None retained

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pain; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory

Limitations and Caveats

Small sample size with missing data

Results Point of Contact

• Title: Marilyn Moy, MD, MSc
• Organization: VA Boston Healthcare System

marilyn.moy@va.gov

857-203-6622

Study Officials

• Marilyn L. Moy, MD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 2, 2020
• Study Start: July 1, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)