Trial Outcomes & Findings for Increasing Physical Activity in COPD Through Rhythmically Enhanced Music (NCT NCT03655028)
NCT ID: NCT03655028
Last Updated: 2025-03-17
Results Overview
Patients will be instructed to walk as fast as they can without running for six minutes. The test will be conducted according to ATS standards. Distance will be recorded in meters walked. Outcomes will be compared between the intervention groups.
COMPLETED
NA
93 participants
12 weeks
2025-03-17
Participant Flow
93 participants met the criteria and were randomized into the study.
Participant milestones
| Measure |
RAS-music Group
Home-based, exercise program augmented with rhythmically auditory stimulation enhanced music
rhythmically auditory stimulation enhanced music: Patients in the intervention group will listen to music enhanced by rhythmic auditory stimulation while engaging in a 12-week home-based exercise program
|
Control Group
Home-based, exercise program without rhythmically auditory stimulation enhanced music
control: Patients in the control group will not listen to music while engaging in a 12-week home-based exercise program
|
|---|---|---|
|
Baseline
STARTED
|
46
|
47
|
|
Baseline
COMPLETED
|
46
|
47
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
12-weeks Follow up
STARTED
|
46
|
47
|
|
12-weeks Follow up
COMPLETED
|
36
|
40
|
|
12-weeks Follow up
NOT COMPLETED
|
10
|
7
|
|
24-weeks
STARTED
|
36
|
40
|
|
24-weeks
COMPLETED
|
35
|
38
|
|
24-weeks
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
RAS-music Group
Home-based, exercise program augmented with rhythmically auditory stimulation enhanced music
rhythmically auditory stimulation enhanced music: Patients in the intervention group will listen to music enhanced by rhythmic auditory stimulation while engaging in a 12-week home-based exercise program
|
Control Group
Home-based, exercise program without rhythmically auditory stimulation enhanced music
control: Patients in the control group will not listen to music while engaging in a 12-week home-based exercise program
|
|---|---|---|
|
12-weeks Follow up
Death
|
1
|
0
|
|
12-weeks Follow up
Physician Decision
|
3
|
3
|
|
12-weeks Follow up
Withdrawal by Subject
|
2
|
0
|
|
12-weeks Follow up
Lost to Follow-up
|
4
|
4
|
|
24-weeks
Lost to Follow-up
|
1
|
1
|
|
24-weeks
Death
|
0
|
1
|
Baseline Characteristics
Increasing Physical Activity in COPD Through Rhythmically Enhanced Music
Baseline characteristics by cohort
| Measure |
Intervention
n=46 Participants
Music plus 12-week walking program
|
Control
n=47 Participants
12-week walking program only
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 6 • n=5 Participants
|
73 years
STANDARD_DEVIATION 6 • n=7 Participants
|
71 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
FEV1
|
1.49 Liters
STANDARD_DEVIATION .51 • n=5 Participants
|
1.39 Liters
STANDARD_DEVIATION .46 • n=7 Participants
|
1.44 Liters
STANDARD_DEVIATION .49 • n=5 Participants
|
|
FEV1 percent predicted
|
48 percent predicted
STANDARD_DEVIATION 13 • n=5 Participants
|
45 percent predicted
STANDARD_DEVIATION 15 • n=7 Participants
|
47 percent predicted
STANDARD_DEVIATION 14 • n=5 Participants
|
|
FEV1/FVC
|
51 percent
STANDARD_DEVIATION 11 • n=5 Participants
|
47 percent
STANDARD_DEVIATION 13 • n=7 Participants
|
49 percent
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Six minute walk distance
|
433 meters
STANDARD_DEVIATION 81 • n=5 Participants
|
403 meters
STANDARD_DEVIATION 98 • n=7 Participants
|
418 meters
STANDARD_DEVIATION 91 • n=5 Participants
|
|
Dyspnea
|
3.4 units on scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
3.5 units on scale
STANDARD_DEVIATION 1.6 • n=7 Participants
|
3.5 units on scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Daily step count
|
3308 steps per day
STANDARD_DEVIATION 1346 • n=5 Participants
|
2750 steps per day
STANDARD_DEVIATION 1648 • n=7 Participants
|
3008 steps per day
STANDARD_DEVIATION 1532 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants assigned to each group who completed 12-week testing
Patients will be instructed to walk as fast as they can without running for six minutes. The test will be conducted according to ATS standards. Distance will be recorded in meters walked. Outcomes will be compared between the intervention groups.
Outcome measures
| Measure |
Intervention
n=36 Participants
Music plus 12-week walking program
|
Control
n=40 Participants
12-week walking program only
|
|---|---|---|
|
Six-minute Walk Distance
|
452 meters
Standard Deviation 79
|
429 meters
Standard Deviation 105
|
SECONDARY outcome
Timeframe: 12 weeksVolume of daily physical activity over a seven day period will be recorded using a triaxial accelerometer worn on the hip (actigraph). Volume of physical activity will be compared between the intervention group and the control group.
Outcome measures
| Measure |
Intervention
n=36 Participants
Music plus 12-week walking program
|
Control
n=40 Participants
12-week walking program only
|
|---|---|---|
|
Volume of Daily Physical Activity
|
3930 steps per day
Standard Deviation 2551
|
3738 steps per day
Standard Deviation 2566
|
SECONDARY outcome
Timeframe: 24 weeksTo determine whether, 24-weeks after randomization, gains in 6-minute walk distance and perceived functional improvements will be sustained to a greater extent in the rhythmic auditory stimulation enhanced music group than in the control group the six-minutes walk test will be repeated 24-weeks after randomization. During the six-minute walk test patients will be instructed to walk as fast as they can without running for six minutes. The test will be conducted according to ATS standards. Distance will be recorded in meters walked. Outcomes will be compared between the two groups.
Outcome measures
| Measure |
Intervention
n=35 Participants
Music plus 12-week walking program
|
Control
n=38 Participants
12-week walking program only
|
|---|---|---|
|
Six-minute Walk Distance
|
444 meters
Standard Deviation 82
|
439 meters
Standard Deviation 107
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: numbers of subjects are inconsistent because subjects did not complete the questionnaires
measured by the Short Form-36 Physical component score. Scores range from 0-100 (higher scores are better).
Outcome measures
| Measure |
Intervention
n=33 Participants
Music plus 12-week walking program
|
Control
n=39 Participants
12-week walking program only
|
|---|---|---|
|
Quality of Life Physical Function
|
40.4 score on a scale
Standard Deviation 6.0
|
38.7 score on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: 12-weeksPopulation: some subjects did not complete the questionnaires
Quality of Life measured by Short Form-36 Mental Component Scale (range=0-100; higher score is better)
Outcome measures
| Measure |
Intervention
n=33 Participants
Music plus 12-week walking program
|
Control
n=39 Participants
12-week walking program only
|
|---|---|---|
|
Quality of Life Mental Health
|
42.8 score on a scale
Standard Deviation 6.1
|
42.3 score on a scale
Standard Deviation 6.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: total number of sessions completed
number of walking exercise sessions completed
Outcome measures
| Measure |
Intervention
n=36 Participants
Music plus 12-week walking program
|
Control
n=40 Participants
12-week walking program only
|
|---|---|---|
|
Adherence to Training Sessions Protocol
|
25.6 number of training sessions completed
Standard Deviation 10.7
|
19.7 number of training sessions completed
Standard Deviation 12.8
|
Adverse Events
Intervention
Control
Serious adverse events
| Measure |
Intervention
n=46 participants at risk
Music plus 12-week walking program
|
Control
n=47 participants at risk
12-week walking program only
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
6.5%
3/46 • Number of events 3 • Adverse events are reported from randomization to study completion (typically 6-8 months)
|
6.4%
3/47 • Number of events 3 • Adverse events are reported from randomization to study completion (typically 6-8 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/46 • Adverse events are reported from randomization to study completion (typically 6-8 months)
|
2.1%
1/47 • Number of events 1 • Adverse events are reported from randomization to study completion (typically 6-8 months)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place