COPD
Conditions
Keywords
COPD, Vibration, Rehabilitation
Brief summary
Dyspnea, the sensation of breathing discomfort or shortness of breath, is one of the main symptoms for patients affected by Chronic Obstructive Pulmonary Disease (COPD), particularly during exercise. Previous study show that chest wall vibration decrease dyspnea in COPD patients and precisely when applied during the inspiration phase, called in-phase vibration (IPV) which provide vibration directly on intercostal muscles. These findings have been obtained in laboratory context and the intercostals muscles vibration has been tested only in single phases of breathing, during inspiration with IPV and during exhalation with out-of-phase vibration (OPV). None study has evaluated the effect of a continuous chest wall vibration (CCWV), namely muscles vibration during the whole cycle of breathing, on dyspnea in patients with COPD in a clinical context. Continuous high frequency vibration has been proven to reduce myoelectrical manifestation of fatigue, probably modifying the centrally driven motor unit recruitment hierarchy, in healthy subjects. Moreover, CCWV is a modality of provide vibration more suitable and cost-effective in a clinical context than single-phases vibration that requires specific instruments for the detection of breathing phases and the coupling with vibration device. On these bases, the investigators hypothesized that CCWV at high frequency, applied during a cycle ergometer training program, could decrease dyspnea and enhance the exercise tolerance in COPD patients. Therefore, the aim of this study is to evaluate the effects of high frequency CCWV on dyspnea and exercise tolerance in patients with COPD patients compared to usual care and to sham intervention.
Interventions
Already in arm/group descriptions
OTHERAirway clearance program
Already in arm/group descriptions
DEVICEVibration therapy
Already in arm/group descriptions
DEVICESham vibration therapy
Already in arm/group descriptions
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- COPD diagnosis (GOLD stage: 2-3-4)
Exclusion criteria
* Restrictive lung disease * Active pulmonary infection * Pulmonary embolism (less than 3 months) * Pneumotorax * Thoracic/abdominal operation (less than 3 months) * Myocardial infarction (less than 6 months) * Congestive heart failure/ heart failure/ right heart failure * Angina/severe angina * Incapability of perform the cycle ergometer training (e.g. orthopaedic or urogenital conditions) * Incapability to understand the intructions required to carry out the tests and assessments planned
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Dyspnea | Change from Baseline Barthel Index based on dyspnea at 4 weeks | Barthel Index based on dyspnea. The scale measures the level of dyspnea perceived in performing basic daily living activities, Range: 0 - 100 Higher values represent a worse outcome |
| Change of exercise tolerance | Change from Baseline exercise tolerance at 4 weeks | Six Minutes Walking Test. This test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. Higher values represent a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of respiratory muscles strength | Change from Baseline respiratory muscles strength at 4 weeks | Maximum inspiratory pressure / Minimum expiratory pressure. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are global measures of maximal strength of respiratory muscles and they are respectively the greater pressure which may be generated during maximal inspiration and expiration against an occluded airway. The way to measure maximal respiratory pressures is very simple, using a hand-held mouth pressure meter in cmH2O. Higher values represent a better outcome |
| Change of Risk of death | Change from Baseline risk of death at 4 weeks | BODE Index. Is a multidimensional 10-point grading system that predicts the risk of death from any cause and from respiratory causes among patients with COPD. It is composed by subscales, combined to compute a total score as follows: FEV1 (% of predicted): 0 (≥65); 1 (50-64); 2 (36-49); 3 (≤35). Distance walked in 6 minutes (m): 0 (≥350); 1 (250-349); 2 150-249); 3 (≤149). MMRC dyspnea scale:0 (0-1); 1 (2); 2 (3); 3 (4). Body-mass Index: 0 (\>21); 1 (≤21). Range: 0-10 Higher scores indicate a worse outcome (higher risk of death) |
| Change of Health-related quality of life | Change from Baseline health-related quality at 4 weeks | Saint George Respiratory Questionnaire. Is a self-reported, disease-specific, health-related quality of life questionnaire. Range: 0 (no health impairment) - 100 (maximum health impairment). Higher values represent a worse outcome |
| Change of Sympatho-vagal balance | Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks | Heart Rate Variability |
Countries
Italy
Outcome results
None listed