Trial Outcomes & Findings for BRAIN, Symptoms, and Physical Activity in COPD (NCT NCT04291131)

NCT ID: NCT04291131

Last Updated: 2025-08-15

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 9 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-08-15

Participant Flow

Participant milestones

Measure	Veterans With COPD Veterans with COPD who will participate in a physical activity intervention or exercise program
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

6 participants did not complete questionnaire at baseline

Baseline characteristics by cohort

Measure	Veterans With COPD n=9 Participants Veterans with COPD who will participate in a physical activity intervention or exercise program
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=9 Participants
Age, Categorical >=65 years	7 Participants n=9 Participants
Age, Continuous	73 years STANDARD_DEVIATION 6 • n=9 Participants
Sex: Female, Male Female	0 Participants n=9 Participants
Sex: Female, Male Male	9 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants
Race (NIH/OMB) White	9 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Region of Enrollment United States	9 Participants n=9 Participants
Cortical thickness	2.24 mm STANDARD_DEVIATION 0.1 • n=9 Participants
Pain	4 units on a scale STANDARD_DEVIATION 3 • n=3 Participants • 6 participants did not complete questionnaire at baseline
Dyspnea	2.38 units on a scale STANDARD_DEVIATION 1.3 • n=8 Participants • 1 missing value
Exercise capacity	1052 feet STANDARD_DEVIATION 263 • n=5 Participants • Exercise capacity assessed by the 6-minute walk test where participant is asked to walk and cover as much ground as possible in 6 minutes. This is a validated test in patients with COPD. 4 missing values
Physical Activity	4519 steps per day STANDARD_DEVIATION 2497 • n=5 Participants • 4 missing participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Veterans With COPD n=6 Participants Veterans with COPD who will participate in a physical activity intervention or exercise program
Cortical Thickness	2.2 mm Standard Deviation 0.06

SECONDARY outcome

Timeframe: 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.

measured by the 6-minute walk test

Outcome measures

Measure	Veterans With COPD n=2 Participants Veterans with COPD who will participate in a physical activity intervention or exercise program
Exercise Capacity	1410 feet Standard Deviation 80

SECONDARY outcome

Timeframe: 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.

Measured by daily step counts

Outcome measures

Measure	Veterans With COPD n=5 Participants Veterans with COPD who will participate in a physical activity intervention or exercise program
Physical Activity	4835 steps per day Standard Deviation 3226

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Veterans With COPD n=2 Participants Veterans with COPD who will participate in a physical activity intervention or exercise program
Pain Intensity	4 units on a scale Standard Deviation 1.41

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Dyspnea will be measured with the modified Medical Research Council scale from 0 to 4 where a higher score means greater dyspnea.

Outcome measures

Measure	Veterans With COPD n=6 Participants Veterans with COPD who will participate in a physical activity intervention or exercise program
Dyspnea	1.83 units on a scale Standard Deviation 1.47

Adverse Events

Veterans With COPD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marilyn Moy, MD, MSc

VA Boston Healthcare System

Phone: 857-203-6622

Email: marilyn.moy@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place