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BRAIN, Symptoms, and Physical Activity in COPD

Effects of Chronic Pain, Dyspnea, and Physical Activity Promotion on Functional Connectivity of the Brain in COPD

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04291131
Acronym
BRAIN-SPA
Enrollment
9
Registered
2020-03-02
Start date
2020-07-01
Completion date
2024-06-30
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Musculoskeletal Pain, COPD

Keywords

COPD, Pain, Dyspnea, Neuroimaging, Functional Connectivity

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.

Detailed description

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).

Interventions

None listed

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cortical Thickness3 monthsCortical thickness will be measured by brain MRIs that will assess functional connectivity and structural variables. Cortical thickness will be reported in millimeters.

Secondary

MeasureTime frameDescription
Exercise Capacity3 monthsmeasured by the 6-minute walk test
Physical Activity3 monthsMeasured by daily step counts

Other

MeasureTime frameDescription
Dyspnea3 monthsDyspnea will be measured with the modified Medical Research Council scale from 0 to 4 where a higher score means greater dyspnea.
Pain Intensity3 monthsPain 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Veterans With COPD
Veterans with COPD who will participate in a physical activity intervention or exercise program
9
Total9

Baseline characteristics

CharacteristicVeterans With COPD
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
7 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
Age, Continuous73 years
STANDARD_DEVIATION 6
Cortical thickness2.24 mm
STANDARD_DEVIATION 0.1
Dyspnea2.38 units on a scale
STANDARD_DEVIATION 1.3
Exercise capacity1052 feet
STANDARD_DEVIATION 263
Pain4 units on a scale
STANDARD_DEVIATION 3
Physical Activity4519 steps per day
STANDARD_DEVIATION 2497
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
9 Participants
Region of Enrollment
United States
9 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 9
other
Total, other adverse events
0 / 9
serious
Total, serious adverse events
0 / 9

Outcome results

Primary

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

Population: Numbers do not match baseline numbers because of missing data. Participants may have completed only some assessments or did not have follow-up assessments.

ArmMeasureValue (MEAN)Dispersion
Veterans With COPDCortical Thickness2.2 mmStandard Deviation 0.06
Secondary

Exercise Capacity

measured by the 6-minute walk test

Time frame: 3 months

Population: Numbers do not match baseline numbers because of missing data. Participants may have completed only some assessments or did not have follow-up assessments.

ArmMeasureValue (MEAN)Dispersion
Veterans With COPDExercise Capacity1410 feetStandard Deviation 80
Secondary

Physical Activity

Measured by daily step counts

Time frame: 3 months

Population: Numbers do not match baseline numbers because of missing data. Participants may have completed only some assessments or did not have follow-up assessments.

ArmMeasureValue (MEAN)Dispersion
Veterans With COPDPhysical Activity4835 steps per dayStandard Deviation 3226
Other Pre-specified

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

Population: Numbers do not match baseline numbers because of missing data. Participants may have completed only some assessments or did not have follow-up assessments.

ArmMeasureValue (MEAN)Dispersion
Veterans With COPDDyspnea1.83 units on a scaleStandard Deviation 1.47
Other Pre-specified

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

Population: Numbers do not match baseline numbers because of missing data. Participants may have completed only some assessments or did not have follow-up assessments.

ArmMeasureValue (MEAN)Dispersion
Veterans With COPDPain Intensity4 units on a scaleStandard Deviation 1.41

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026