An interventional study of Breathing retraining plus exercise and Exercise only in COPD, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
People with moderate to severe COPD trap air in their lungs. This lessens their ability to exercise. The investigators developed a computerized breathing retraining program to help patients empty their lungs during exercise. The investigators believe that learning to control breathing will help patients be more active. The purpose of this study is to test the effects of using breathing retraining (intervention group) versus no breathing retraining (control group) as part of a 12-week exercise program. The investigators are examining the long term effects of this training on exercise capacity and the ability to empty ones lungs during exercise. Patients will participate in a 12-week exercise program, with or without breathing retraining. They will then participate in a 42 week adherence program to maintain physical activity. Patient testing will be competed at baseline, 12 weeks, 6 months and 1 year. 250 patients with moderate to severe COPD will be enrolled.
Rationale: Development of dynamic hyperinflation is a primary limiting factor of exercise tolerance in chronic obstructive pulmonary disease (COPD). To lessen the development of dynamic hyperinflation, and to improve exercise tolerance in COPD patients, the investigators have developed a breathing-retraining technique to be used during pulmonary rehabilitation. This breathing-retraining technique is designed to decrease respiratory rate and prolong exhalation. The investigators demonstrated that, in the short-term, hyperinflation and exercise duration improved more with breathing-retraining plus exercise-training than with exercise-training alone. Because a crucial aspect of pulmonary rehabilitation is the maintenance its short-term benefits over the long-term, the investigators now propose to test whether short-term benefits of breathing-retraining plus exercise followed by an adherence-intervention program are sustainable over the long-term Primary Hypothesis: (H1) In COPD patients, improvements in exercise duration on a constant- load treadmill test will be greater after 12 weeks of breathing-retraining plus exercise-training followed by a 42-week adherence-intervention program (1 yr. total) than after 12 weeks of exercise-training alone followed by a 42-week adherence-intervention program (1 yr. total). Secondary Hypotheses: One year after randomization, exercise-induced dynamic hyperinflation will be less during a constant-load treadmill test (H2), 6-minute walking distance will be longer (H3), and mastery over breathing will be greater (H4) in the breathing-retraining plus exercise-training group than in the exercise-alone group. Lastly (exploratory objective), the investigators will assess the effect of the patient's physiologic, psychologic and clinical phenotype on short- term and long-term responsiveness to pulmonary rehabilitation.
Methods: The proposed study is a randomized, controlled clinical trial in which 250 patients with moderate-to-severe COPD will be enrolled. One hundred forty of these patients are expected to qualify for randomization into the breathing-retraining plus exercise-training group or the exercise-training alone group. Patients will receive 12-weeks of supervised training according to group assignment (three times weekly) followed by an adherence-intervention program (weekly phone motivational interviews, home-exercise program, and monthly laboratory booster sessions). Follow-up testing will be completed at 12 weeks, and at 6 and 12 months. Testing will include pulmonary function test, incremental-load and constant-load treadmill tests, 6-minute walk test, measurements of dyspnea, assessment of respiratory and quadriceps muscle strength and endurance and quadriceps ultrasonography. Analysis: In the principal analysis of the primary outcome measure (exercise duration; H1) the investigators will compare changes in exercise duration (constant work-rate treadmill test) from baseline to end of study using 2-sample t-test (two-tailed =.05). The primary analysis will be based on intention-to-treat principles. Multiple imputation will be used for study subjects missing the 12-month measurement. This imputation model will be based on baseline characteristics of study participants. Several secondary analyses of the primary outcome measure will be performed (H2-H4). Linear regression will be used to determine whether the observed treatment benefits persist after adjustment for baseline covariates and measures of adherence to treatment. Since several measurements will be taken on each patient, mixed-models analysis will be used to compare the changes on the constant-load treadmill test over time between the two groups.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →VA Office of Research and Development is the lead sponsor of 1,767 studies on the registry; 394 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 183 (88%) have results posted.
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Exclusion Criteria:
Patients will exercise for 12 weeks and then participate in an adherence program
Behavioral: Exercise only
Patients will exercise plus breathing retraining for 12 weeks and then participate in an adherence program
Behavioral: Breathing retraining plus exercise
Patients will participate in a 12-week exercise program with breathing retraining. They will also participate in an adherence program.
Patients will participate in a 12-week exercise program . They will also participate in an adherence program.
Duration of Exercise Time on a Constant Work-rate Treadmill Test
Patients walk on a treadmill set at a constant workrate. The difference in the time walked on the treadmill from baseline to study completion is the primary outcome measure.
Time frame: 52 week test
Inspiratory Capacity
Inspiratory capacity is measured at a set time during the constant workrate treadmill test. The difference between the inspiratory capacity measured at baseline and 52 weeks is a secondary outcome. Inspiratory capacity measured during exercise is a measure of dynamic hyperinflation.
Time frame: 52 week test
6 Minute Walk Distance
Six-minute walk distance will be measured at 52 weeks. The difference in distance walked in meters between baseline and 52 weeks is the secondary outcome measure. The 6 minute walk is conducted using the guidelines issued by the American Thoracic Society.
Time frame: 52 weeks
Mastery Over Breathing
Mastery over breathing is measured using the Chronic Respiratory Disease Questionnaire. Specifically the subscale 'mastery" is the investigators' secondary outcome. The difference in scores from baseline to 52 weeks is the investigators' outcome measure. The Chronic Respiratory Disease Questionnaire is a valid and reliable questionnaire. 1=minimum score, 7=maximum with the higher score indicating greater mastery. A higher score indicates better health. A change of 0.5 indicates a small change, 1.0 indicates a moderate change and greater or equal to a change of 1.5 indicates a large change.
Time frame: 52 weeks
| Milestone | Exercise | Exercise Plus Breathing Retraining |
|---|---|---|
| Started | 40 | 40 |
| Completed | 25 | 30 |
| Not completed | 15 | 10 |
| Withdrew: Lost to follow-up | 9 | 4 |
| Withdrew: Physician decision | 6 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Death | 0 | 2 |
Patients walk on a treadmill set at a constant workrate. The difference in the time walked on the treadmill from baseline to study completion is the primary outcome measure.
| change in number of minutes walked | Exercise | Exercise Plus Breathing Retraining |
|---|---|---|
| Duration of Exercise Time on a Constant Work-rate Treadmill Test | 12.2 ± 3.5 | 12.5 ± 3.5 |
Inspiratory capacity is measured at a set time during the constant workrate treadmill test. The difference between the inspiratory capacity measured at baseline and 52 weeks is a secondary outcome. Inspiratory capacity measured during exercise is a measure of dynamic hyperinflation.
| difference in liters inspired | Exercise | Exercise Plus Breathing Retraining |
|---|---|---|
| Inspiratory Capacity | -0.02 ± .07 | .15 ± .07 |
Six-minute walk distance will be measured at 52 weeks. The difference in distance walked in meters between baseline and 52 weeks is the secondary outcome measure. The 6 minute walk is conducted using the guidelines issued by the American Thoracic Society.
| meters | Exercise | Exercise Plus Breathing Retraining |
|---|---|---|
| 6 Minute Walk Distance | 25.9 ± 8.5 | 22.8 ± 8.7 |
Mastery over breathing is measured using the Chronic Respiratory Disease Questionnaire. Specifically the subscale 'mastery" is the investigators' secondary outcome. The difference in scores from baseline to 52 weeks is the investigators' outcome measure. The Chronic Respiratory Disease Questionnaire is a valid and reliable questionnaire. 1=minimum score, 7=maximum with the higher score indicating greater mastery. A higher score indicates better health. A change of 0.5 indicates a small change, 1.0 indicates a moderate change and greater or equal to a change of 1.5 indicates a large change.
| score on a scale | Exercise | Exercise Plus Breathing Retraining |
|---|---|---|
| Mastery Over Breathing | 1.9 ± 4.9 | 2.3 ± 4.6 |
Collected over Adverse event data were collected over the course of study participation (1 year or the time the patients remained in the study).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exercise | 1/40 (2.5%) | 16/40 (40%) | 0/40 (0%) |
| Exercise Plus Breathing Retraining | 2/40 (5%) | 15/40 (37.5%) | 0/40 (0%) |
| Event | Exercise | Exercise Plus Breathing Retraining |
|---|---|---|
| COPD ExacerbationRespiratory, thoracic and mediastinal disorders | 13/40 | 11/40 |
| Atrial fibrillationCardiac disorders | 1/40 | 0/40 |
| Rectal abscessGastrointestinal disorders | 1/40 | 0/40 |
| Kidney stonesRenal and urinary disorders | 1/40 | 0/40 |
| brain aneurysmNervous system disorders | 1/40 | 0/40 |
| cellulitisBlood and lymphatic system disorders | 0/40 | 1/40 |
| meningiomaNervous system disorders | 0/40 | 1/40 |
| leukemiaBlood and lymphatic system disorders | 0/40 | 1/40 |
| strokeVascular disorders | 0/40 | 1/40 |
| Age, Categorical(Participants) | Exercise | Exercise Plus Breathing Retraining | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 14 | 26 |
| >=65 years | 28 | 26 | 54 |
| Age, Continuous(years) | Exercise | Exercise Plus Breathing Retraining | Total |
|---|---|---|---|
| Mean | 66.5 ± 6.6 | 68.3 ± 6.6 | 67.4 ± 6.6 |
| Sex: Female, Male(Participants) | Exercise | Exercise Plus Breathing Retraining | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 38 | 39 | 77 |
| Ethnicity (NIH/OMB)(Participants) | Exercise | Exercise Plus Breathing Retraining | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 5 |
| Not Hispanic or Latino | 36 | 39 | 75 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Exercise | Exercise Plus Breathing Retraining | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 8 | 19 |
| White | 29 | 32 | 61 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Exercise | Exercise Plus Breathing Retraining | Total |
|---|---|---|---|
| United States | 40 | 40 | 80 |
| Time walked on constant workload treadmill test(minutes walked) | Exercise | Exercise Plus Breathing Retraining | Total |
|---|---|---|---|
| Mean | 7.2 ± 1.9 | 7.1 ± 2.0 | 7.2 ± 1.9 |
| Inspiratory capacity(liters) | Exercise | Exercise Plus Breathing Retraining | Total |
|---|---|---|---|
| Mean | 2.09 ± .69 | 1.88 ± .49 | 1.99 ± .59 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Oct 2014 to primary completion in Oct 2018, 48 months.
Results were first posted in Oct 2019, 11 months after primary completion.
Of 796 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 48 months is above that.
Counting every sponsor, half of 848 studies reached it within 24 months; a quarter within 11 and three quarters within 42.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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