Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, physiotherapy care, lung function testing, inflammation
Brief summary
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible, and is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, most commonly cigarette smoking. The disease affects not only the large central airways but also the small, more peripheral airways deeper into the lung, defined as less than 2 mm in diameter. Besides medical treatment, physiotherapy plays a major role in treatment and various methods have been suggested to remove airway of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation when the expired air passes through it. These vibrations are thought to mobilise airway secretions facilitating their clearance and improving breathing. Standard blowing tests, like spirometry, where patients blow forcedly into a machine, have previously been used to investigate the efficacy of flutter devices. However, spirometry assesses the damage of larger airways but not small airways, also known as the silent zone which, crucially, are specifically damaged in COPD. In this study the investigators hypothesise that because the flutter helps clear the airways from the excessive thick mucus produced by COPD patients, these patients may find it easier to breathe and have lower resistance to moving air in and out of their lungs. The main objective of this study is to compare the effect of a flutter or a sham device on small airways damage using impulse oscillometry (IOS), a non-invasive method that, contrary to other common blowing tests, measures small airway resistance during normal breathing. In addition, because COPD is characterised by inflammation, the investigators would also like to measure a gas the patients blow out, nitric oxide (NO) the levels of which reflect airway inflammation. This will give to investigators an insight into the relationship between airway inflammation and small airway function.
Detailed description
Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible. This limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases. Patients suffering from COPD may show pathologic changes not only in the large but also in the small airways, which are defined as less than 2mm in diameter. Airway inflammation may cause increased thick mucus secretions which can narrow the airways increasing the resistance to the airflow. Physiotherapy to remove secretions is indicated for patients with COPD who have regular sputum or those with thick secretions and various techniques and physiotherapy devices can be applied for the removal of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation as expired air passes through it. These vibrations and PEP are thought to mobilise airway secretions facilitating their clearance and improving airflow. The effects of the flutter device have been studied in different patient groups, but especially in lung diseases characterised by mucus hypersecretion such as COPD, cystic fibrosis and bronchiectasis. In COPD, even though the flutter device increases the volume of expectorated secretions, its beneficial effects on pulmonary function as assessed by spirometry and plethysmography are inconclusive. However, these standard lung function tests (such as spirometry) asses the large airways, but do not provide an accurate estimate of the small airways which have been described by some authors as the silent zone. The investigators hypothesise that the use of impulse oscillometry (IOS), a non-invasive technique that provides information on small airway resistance during normal breathing, may reveal the effect of the flutter device which may have not been accurately measured by spirometry in previous studies. In addition, the investigators would like to measure exhaled nitric oxide (NO) levels which reflect airway inflammation and may therefore be useful to determine the association between small airway disease and inflammation. In summary, the symptoms of patients with COPD improve following breathing exercises with a flutter device, however, the effect of this device on lung function is unclear. The investigators hypothesise that the combined use IOS and NO, would help understand and quantify the effects of the flutter device on the small airways disease in COPD. The main objective of this study is to measure the effect of a 30 minutes breathing exercise with a flutter device on airway resistance as assessed by impulse oscillometry in patients with COPD. The secondary objective is to investigate the association between inflammation, airway resistance and volume of secretions in COPD patients.
Interventions
30 minutes of flutter exercises
30 minutes of flutter-sham exercises
Flutter + bronchodilator exercises with an interval of 3 to 5 days
Sponsors
Study design
Eligibility
Inclusion criteria
\- patients with COPD meeting the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, with forced expiratory volume in the first second of expiration (FEV1) \<80% predicted, FEV1/FVC ratio \<70% predicted (FVC= forced vital capacity), and total lung capacity (TLC) \>80% predicted), with or without sputum, will be included. The severity of COPD will be classified according to GOLD criteria: Stage I: mild FEV1/FVC\<0.70 and FEV1\>80% predicted; Stage II: moderate FEV1/FVC\<0.70 and 50\<FEV1\<80% predicted; Stage III: severe FEV1/FVC\<0.70 and 30\<FEV1\<50% predicted; Stage IV: very severe FEV1/FVC\<0.70 and FEV1\<30% or FEV1\<50% predicted plus chronic respiratory failure,
Exclusion criteria
Patients with: * Upper respiratory tract infection within the previous 28 days * Treatment with antibiotics within 4 weeks prior the study * Acute dyspnoea or hemoptysis * Chest pain or recent history of rib fracture or pneumothorax * Acute cardiovascular events in the previous 3 months * Any history or evidence of renal, gastrointestinal or hepatic disease * Any history and evidence of neuropsychiatric disease * Alcohol, drug abuse or any other condition associated with poor compliance * Breast feeding * Pregnancy * Other complications that hinder the completion of the tests * Unable to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airways Resistance (IOS) | Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest | Airways resistance were measured by impulse oscillometry (IOS) method. |
| Airways Resistance (IOS) - Reactance Area (Ax) | Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest | Airways resistance were measured by impulse oscillometry (IOS) method. |
| Airways Resistance (IOS) - Resonant Frequency (Fres) | Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest | Airways resistance were measured by impulse oscillometry (IOS) method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled Nitric Oxide (FeNO) | Baseline and immediately after intervention | Exhaled nitric oxide will be measured by chemiluminescence method. |
| Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline and immediately after intervention | Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany) |
| Cough | During each session | Number of spontaneously reported cough episodes during each visit were collected. |
| Secretion - Volume | During each session | Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score. |
| Secretion - Purulence Score | In each session | The expectorated secretion was collected, weighted and classified with a purulence score based on a previously described numerical visual scale, which ranges from 1 (mucoid) to 5 (yellow/green). Referee of the Purulence score: Barnes PJ, Dweik RA, Gelb AF, et al. Exhaled nitric oxide in pulmonary diseases: a comprehensive review. Chest. 2010;138:682-692. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patient All volunteers had a following treatments as crossover design Visit 1: medical history, physical examination and written informed consent
Visit 2: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device
Visit 3: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises
Visit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | All Patient | — |
|---|---|---|
| Age, Continuous | 67.3 years STANDARD_DEVIATION 9.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 15 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Airways Resistance (IOS)
Airways resistance were measured by impulse oscillometry (IOS) method.
Time frame: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Population: Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis, and no recent history of rib fractures or pneumothorax.~In the Flutter-sham Control group after 20 minutes of rest - no data was collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flutter Exercises Session | Airways Resistance (IOS) | R5 (kPa/L/s) Baseline | 0.63 kPa/L/s | Standard Deviation 0.16 |
| Flutter Exercises Session | Airways Resistance (IOS) | R5 (kPa/L/s) Immediately after | 0.68 kPa/L/s | Standard Deviation 0.21 |
| Flutter Exercises Session | Airways Resistance (IOS) | R5 (kPa/L/s) After 20 minutes of rest | 0.61 kPa/L/s | Standard Deviation 0.18 |
| Flutter Exercises Session | Airways Resistance (IOS) | R20 (kPa/L/s) Baseline | 0.42 kPa/L/s | Standard Deviation 0.12 |
| Flutter Exercises Session | Airways Resistance (IOS) | R20 (kPa/L/s) Immediately after | 0.43 kPa/L/s | Standard Deviation 0.14 |
| Flutter Exercises Session | Airways Resistance (IOS) | R20 (kPa/L/s) After 20 minutes of rest | 0.41 kPa/L/s | Standard Deviation 0.15 |
| Flutter Exercises Session | Airways Resistance (IOS) | R5-R20 (kPa/L/s) Baseline | 0.21 kPa/L/s | Standard Deviation 0.08 |
| Flutter Exercises Session | Airways Resistance (IOS) | R5-R20 (kPa/L/s) Immediately after | 0.25 kPa/L/s | Standard Deviation 0.1 |
| Flutter Exercises Session | Airways Resistance (IOS) | R5-R20 (kPa/L/s) After 20 minutes of rest | 0.20 kPa/L/s | Standard Deviation 0.06 |
| Flutter Exercises Session | Airways Resistance (IOS) | X5 (kPa/L/s) Baseline | -0.27 kPa/L/s | Standard Deviation 0.1 |
| Flutter Exercises Session | Airways Resistance (IOS) | X5 (kPa/L/s) Immediately after | -0.28 kPa/L/s | Standard Deviation 0.11 |
| Flutter Exercises Session | Airways Resistance (IOS) | X5 (kPa/L/s) After 20 minutes of rest | -0.26 kPa/L/s | Standard Deviation 0.1 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | X5 (kPa/L/s) After 20 minutes of rest | -0.25 kPa/L/s | Standard Deviation 0.12 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | R5 (kPa/L/s) Baseline | 0.61 kPa/L/s | Standard Deviation 0.28 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | R5-R20 (kPa/L/s) Baseline | 0.20 kPa/L/s | Standard Deviation 0.15 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | R5-R20 (kPa/L/s) After 20 minutes of rest | 0.18 kPa/L/s | Standard Deviation 0.25 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | R5 (kPa/L/s) Immediately after | 0.63 kPa/L/s | Standard Deviation 0.26 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | R20 (kPa/L/s) After 20 minutes of rest | 0.39 kPa/L/s | Standard Deviation 0.14 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | X5 (kPa/L/s) Immediately after | -0.25 kPa/L/s | Standard Deviation 0.11 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | R5 (kPa/L/s) After 20 minutes of rest | 0.56 kPa/L/s | Standard Deviation 0.24 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | R5-R20 (kPa/L/s) Immediately after | 0.21 kPa/L/s | Standard Deviation 0.12 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | R20 (kPa/L/s) Immediately after | 0.42 kPa/L/s | Standard Deviation 0.16 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | R20 (kPa/L/s) Baseline | 0.41 kPa/L/s | Standard Deviation 0.15 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) | X5 (kPa/L/s) Baseline | -0.27 kPa/L/s | Standard Deviation 0.15 |
| Flutter-sham - Control Group | Airways Resistance (IOS) | R20 (kPa/L/s) Baseline | 0.40 kPa/L/s | Standard Deviation 0.15 |
| Flutter-sham - Control Group | Airways Resistance (IOS) | R20 (kPa/L/s) Immediately after | 0.41 kPa/L/s | Standard Deviation 0.13 |
| Flutter-sham - Control Group | Airways Resistance (IOS) | X5 (kPa/L/s) Baseline | -0.23 kPa/L/s | Standard Deviation 0.08 |
| Flutter-sham - Control Group | Airways Resistance (IOS) | R20 (kPa/L/s) After 20 minutes of rest | NA kPa/L/s | — |
| Flutter-sham - Control Group | Airways Resistance (IOS) | R5-R20 (kPa/L/s) Baseline | 0.19 kPa/L/s | Standard Deviation 0.1 |
| Flutter-sham - Control Group | Airways Resistance (IOS) | R5-R20 (kPa/L/s) Immediately after | 0.19 kPa/L/s | Standard Deviation 0.11 |
| Flutter-sham - Control Group | Airways Resistance (IOS) | X5 (kPa/L/s) Immediately after | -0.24 kPa/L/s | Standard Deviation 0.09 |
| Flutter-sham - Control Group | Airways Resistance (IOS) | R5 (kPa/L/s) Baseline | 0.58 kPa/L/s | Standard Deviation 0.15 |
| Flutter-sham - Control Group | Airways Resistance (IOS) | R5 (kPa/L/s) Immediately after | 0.60 kPa/L/s | Standard Deviation 0.22 |
| Flutter-sham - Control Group | Airways Resistance (IOS) | R5-R20 (kPa/L/s) After 20 minutes of rest | NA kPa/L/s | — |
| Flutter-sham - Control Group | Airways Resistance (IOS) | R5 (kPa/L/s) After 20 minutes of rest | NA kPa/L/s | — |
| Flutter-sham - Control Group | Airways Resistance (IOS) | X5 (kPa/L/s) After 20 minutes of rest | NA kPa/L/s | — |
Airways Resistance (IOS) - Reactance Area (Ax)
Airways resistance were measured by impulse oscillometry (IOS) method.
Time frame: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Population: No data was collected from the Flutter-sham Control group after 20 minutes of rest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flutter Exercises Session | Airways Resistance (IOS) - Reactance Area (Ax) | Ax (kPa/L) Immediately after | -0.06 kPa/L | Standard Deviation 0.2 |
| Flutter Exercises Session | Airways Resistance (IOS) - Reactance Area (Ax) | Ax (kPa/L) Baseline | -0.13 kPa/L | Standard Deviation 0.17 |
| Flutter Exercises Session | Airways Resistance (IOS) - Reactance Area (Ax) | Ax (kPa/L) After 20 minutes of rest | -0.10 kPa/L | Standard Deviation 0.16 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) - Reactance Area (Ax) | Ax (kPa/L) Immediately after | -0.20 kPa/L | Standard Deviation 0.26 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) - Reactance Area (Ax) | Ax (kPa/L) Baseline | -0.19 kPa/L | Standard Deviation 0.3 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) - Reactance Area (Ax) | Ax (kPa/L) After 20 minutes of rest | -0.18 kPa/L | Standard Deviation 0.26 |
| Flutter-sham - Control Group | Airways Resistance (IOS) - Reactance Area (Ax) | Ax (kPa/L) Baseline | 1.89 kPa/L | Standard Deviation 1.18 |
| Flutter-sham - Control Group | Airways Resistance (IOS) - Reactance Area (Ax) | Ax (kPa/L) After 20 minutes of rest | NA kPa/L | — |
| Flutter-sham - Control Group | Airways Resistance (IOS) - Reactance Area (Ax) | Ax (kPa/L) Immediately after | 2.22 kPa/L | Standard Deviation 1.62 |
Airways Resistance (IOS) - Resonant Frequency (Fres)
Airways resistance were measured by impulse oscillometry (IOS) method.
Time frame: Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest
Population: No data was collected from the Flutter-sham Control group after 20 minutes of rest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flutter Exercises Session | Airways Resistance (IOS) - Resonant Frequency (Fres) | Fres (Hz) Immediately after | 26.15 Hz | Standard Deviation 4.78 |
| Flutter Exercises Session | Airways Resistance (IOS) - Resonant Frequency (Fres) | Fres (Hz) Baseline | 24.95 Hz | Standard Deviation 4.03 |
| Flutter Exercises Session | Airways Resistance (IOS) - Resonant Frequency (Fres) | Fres (Hz) After 20 minutes of rest | 24.24 Hz | Standard Deviation 4.29 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) - Resonant Frequency (Fres) | Fres (Hz) Immediately after | 23.49 Hz | Standard Deviation 6.14 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) - Resonant Frequency (Fres) | Fres (Hz) Baseline | 22.54 Hz | Standard Deviation 7.7 |
| Flutter+Bronchodilator Session | Airways Resistance (IOS) - Resonant Frequency (Fres) | Fres (Hz) After 20 minutes of rest | 21.85 Hz | Standard Deviation 7.01 |
| Flutter-sham - Control Group | Airways Resistance (IOS) - Resonant Frequency (Fres) | Fres (Hz) Baseline | 22.13 Hz | Standard Deviation 5.71 |
| Flutter-sham - Control Group | Airways Resistance (IOS) - Resonant Frequency (Fres) | Fres (Hz) After 20 minutes of rest | NA Hz | — |
| Flutter-sham - Control Group | Airways Resistance (IOS) - Resonant Frequency (Fres) | Fres (Hz) Immediately after | 22.41 Hz | Standard Deviation 8.24 |
Cough
Number of spontaneously reported cough episodes during each visit were collected.
Time frame: During each session
Population: Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flutter Exercises Session | Cough | 3.95 Coughs | Standard Deviation 2.41 |
| Flutter+Bronchodilator Session | Cough | 1.69 Coughs | Standard Deviation 1.49 |
| Flutter-sham - Control Group | Cough | 3.63 Coughs | Standard Deviation 3.07 |
Exhaled Nitric Oxide (FeNO)
Exhaled nitric oxide will be measured by chemiluminescence method.
Time frame: Baseline and immediately after intervention
Population: Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flutter Exercises Session | Exhaled Nitric Oxide (FeNO) | Baseline | 40.5 parts per billion | Standard Deviation 29.9 |
| Flutter Exercises Session | Exhaled Nitric Oxide (FeNO) | After intervention | 39.3 parts per billion | Standard Deviation 33.7 |
| Flutter+Bronchodilator Session | Exhaled Nitric Oxide (FeNO) | Baseline | 44.4 parts per billion | Standard Deviation 33.7 |
| Flutter+Bronchodilator Session | Exhaled Nitric Oxide (FeNO) | After intervention | 43.6 parts per billion | Standard Deviation 33.2 |
| Flutter-sham - Control Group | Exhaled Nitric Oxide (FeNO) | Baseline | 32.3 parts per billion | Standard Deviation 29.4 |
| Flutter-sham - Control Group | Exhaled Nitric Oxide (FeNO) | After intervention | 31.7 parts per billion | Standard Deviation 32 |
Secretion - Purulence Score
The expectorated secretion was collected, weighted and classified with a purulence score based on a previously described numerical visual scale, which ranges from 1 (mucoid) to 5 (yellow/green). Referee of the Purulence score: Barnes PJ, Dweik RA, Gelb AF, et al. Exhaled nitric oxide in pulmonary diseases: a comprehensive review. Chest. 2010;138:682-692.
Time frame: In each session
Population: COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flutter Exercises Session | Secretion - Purulence Score | 2.30 score on a scale | Standard Deviation 0.82 |
| Flutter+Bronchodilator Session | Secretion - Purulence Score | 2.57 score on a scale | Standard Deviation 0.79 |
| Flutter-sham - Control Group | Secretion - Purulence Score | 2.60 score on a scale | Standard Deviation 1.34 |
Secretion - Volume
Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score.
Time frame: During each session
Population: COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax~The volume fo secretion was obtained only for two groups: Flutter exercises and flutter-sham exercises.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flutter Exercises Session | Secretion - Volume | 2.54 grams | Standard Deviation 1.39 |
| Flutter+Bronchodilator Session | Secretion - Volume | 1.5 grams | Standard Deviation 1.33 |
Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)
Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany)
Time frame: Baseline and immediately after intervention
Population: Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flutter Exercises Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline FVC (%) | 109.4 percent predicted spirometry assessment | Standard Deviation 18.4 |
| Flutter Exercises Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention FVC (%) | 107.3 percent predicted spirometry assessment | Standard Deviation 18.1 |
| Flutter Exercises Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline FEV1 (%) | 67.6 percent predicted spirometry assessment | Standard Deviation 17.7 |
| Flutter Exercises Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention FEV1 (%) | 66.0 percent predicted spirometry assessment | Standard Deviation 15.5 |
| Flutter Exercises Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline FEV1/FVC (%) | 51.0 percent predicted spirometry assessment | Standard Deviation 13 |
| Flutter Exercises Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention FEV1/FVC (%) | 51.0 percent predicted spirometry assessment | Standard Deviation 12.5 |
| Flutter Exercises Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline MEF 25-75 (%) | 18.93 percent predicted spirometry assessment | Standard Deviation 8 |
| Flutter Exercises Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention MEF 25-75 (%) | 18.0 percent predicted spirometry assessment | Standard Deviation 7.1 |
| Flutter+Bronchodilator Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline FEV1 (%) | 67.0 percent predicted spirometry assessment | Standard Deviation 17.3 |
| Flutter+Bronchodilator Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline MEF 25-75 (%) | 17.8 percent predicted spirometry assessment | Standard Deviation 6.8 |
| Flutter+Bronchodilator Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention FEV1 (%) | 65.3 percent predicted spirometry assessment | Standard Deviation 14.6 |
| Flutter+Bronchodilator Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline FEV1/FVC (%) | 50.3 percent predicted spirometry assessment | Standard Deviation 12 |
| Flutter+Bronchodilator Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention FEV1/FVC (%) | 49.7 percent predicted spirometry assessment | Standard Deviation 10.8 |
| Flutter+Bronchodilator Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline FVC (%) | 109.8 percent predicted spirometry assessment | Standard Deviation 19.6 |
| Flutter+Bronchodilator Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention FVC (%) | 109.0 percent predicted spirometry assessment | Standard Deviation 17.5 |
| Flutter+Bronchodilator Session | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention MEF 25-75 (%) | 17.6 percent predicted spirometry assessment | Standard Deviation 6.9 |
| Flutter-sham - Control Group | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline FEV1 (%) | 62.1 percent predicted spirometry assessment | Standard Deviation 16.7 |
| Flutter-sham - Control Group | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention FVC (%) | 102.1 percent predicted spirometry assessment | Standard Deviation 18 |
| Flutter-sham - Control Group | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline FVC (%) | 105.8 percent predicted spirometry assessment | Standard Deviation 16.2 |
| Flutter-sham - Control Group | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention FEV1 (%) | 60.3 percent predicted spirometry assessment | Standard Deviation 17.1 |
| Flutter-sham - Control Group | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline MEF 25-75 (%) | 15.7 percent predicted spirometry assessment | Standard Deviation 6.4 |
| Flutter-sham - Control Group | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention FEV1/FVC (%) | 48.9 percent predicted spirometry assessment | Standard Deviation 12.8 |
| Flutter-sham - Control Group | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | Baseline FEV1/FVC (%) | 48.5 percent predicted spirometry assessment | Standard Deviation 12.8 |
| Flutter-sham - Control Group | Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC) | After intervention MEF 25-75 (%) | 15.1 percent predicted spirometry assessment | Standard Deviation 7 |