COPD, Dyspnea
Conditions
Brief summary
Dyspnea is the most common symptom limiting the ability of COPD patients to perform activities of daily living. Although there has been research involving the benefit of providing Non Invasive Ventilation (NIV) during exercise to increase tolerance overall, there is little research specifically looking at shortening dyspnea recovery times associated with exercise. We hypothesize that providing intermittent non-invasive positive pressure therapy (a form of NIV or PAP) with a handheld device to COPD patients immediately after exertion can relieve their dyspnea, and consequently allow them to be more active. In this study, we are comparing the distance walked as measured by a modified 6-Minute Walk Test (6MWT) of 20 COPD patients using VitaBreath (NIV) device versus Pursed Lip Breathing.
Interventions
DEVICEVitabreath Device
The VitaBreath device is designed for non-continuous use only and typical device use is expected to be for 2-3 minutes. The device should only be operated for less than 10 minutes at a time. After such time, the device should be turned off for at least 30 minutes
OTHERPursed Lip Breathing
Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator.
Sponsors
Philips Respironics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will receive two different interventions after exertion.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 40 * Ability to provide consent * COPD diagnosis * Forced Expiratory Volume in one second (FEV1) \<55 and ≥ 25 percent of predicted value * Perceived Shortness of Breath via the Modified Medical Research Counsel Dyspnea questionnaire (rating of 2 or greater) (Appendix B) * Able to follow directions * Able to tolerate mild physical activity * Pursed Lip Breathing as standard of care * No evidence of bullous lung disease (with any bullae greater than 3cm in diameter) as confirmed by a CT scan within the past one year.
Exclusion criteria
* Subjects who are acutely ill, medically complicated or who are medically unstable as determined by the investigator. * Suffering from COPD exacerbation at time of enrollment or 60 days prior * Subjects who are not currently prescribed oxygen and manifest oxygen desaturation below 88% on the screening 6MWT * Subjects with heart disease or neuromuscular disease. * Subjects who are not prescribed short-acting bronchodilator medication * Patients who have experienced recent barotrauma or pneumothorax * Unstable angina or Myocardial Infarction during past month * Uncontrolled Hypertension (systolic blood pressure of \>180mmHg (millimeters of Mercury) and a diastolic \>100mmHg) * Heart Rate \>120 at rest * Subjects who have trouble coordinating their breathing with the device during the device training, or cannot tolerate the device mouthpiece resulting in leaks from the nasal cavity * Women of child-bearing potential (WOCP) who are pregnant, breast-feeding, or planning pregnancy during the course of the study. (WOCP must have a negative pregnancy test at every visit)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Distance During Modified 6 Minute Walk Test | 15 minutes | Compare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants that were consented. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Screening | Screen Fail | 4 | 0 | 0 |
| Screening | Withdrawn | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 7.8 |
| Body Mass Index (BMi) | 27.4 kg/m^2 STANDARD_DEVIATION 6.7 |
| Diastolic Blood Pressure (mmHg) | 78.5 mmHg STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| FEV1(L) | 1.3 Liters STANDARD_DEVIATION 0.6 |
| FEV1 (% Predicted) | 40.0 percentage of predicted FEV1 STANDARD_DEVIATION 16.8 |
| FVC (L) | 6.7 Liters STANDARD_DEVIATION 22 |
| FVC (% Predicted) | 56.9 percentage of predicted FVC STANDARD_DEVIATION 13.2 |
| Heart Rate (bpm) | 81.7 beats per minute STANDARD_DEVIATION 16.6 |
| Pack Years | 58.8 packs per year STANDARD_DEVIATION 31.4 |
| 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 | 25 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 17 Participants |
| Systolic Blood Pressure (mmHg) | 136.1 mmHg STANDARD_DEVIATION 16.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 25 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 25 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Average Distance During Modified 6 Minute Walk Test
Compare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath.
Time frame: 15 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitabreath Device | Average Distance During Modified 6 Minute Walk Test | 1st Hallf of M 6MWT Distance | 128.0 meters | Standard Deviation 47.5 |
| Vitabreath Device | Average Distance During Modified 6 Minute Walk Test | 2nd half of M 6MWT Distance | 137.5 meters | Standard Deviation 49.7 |
| Vitabreath Device | Average Distance During Modified 6 Minute Walk Test | Total M 6 MWT Distance | 265.5 meters | Standard Deviation 96.3 |
| Pursed Lip Breathing | Average Distance During Modified 6 Minute Walk Test | 1st Hallf of M 6MWT Distance | 129.9 meters | Standard Deviation 43.3 |
| Pursed Lip Breathing | Average Distance During Modified 6 Minute Walk Test | 2nd half of M 6MWT Distance | 121.3 meters | Standard Deviation 38.9 |
| Pursed Lip Breathing | Average Distance During Modified 6 Minute Walk Test | Total M 6 MWT Distance | 251.2 meters | Standard Deviation 80.8 |
p-value: 0.02Wilcoxon Signed Rank