Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza
Rovato, Brescia, 25038, Italy
NCT Number: NCT03644888
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Rovato, Brescia, 25038, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Already in arm/group descriptions
Already in arm/group descriptions
Already in arm/group descriptions
Already in arm/group descriptions
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks
Heart Rate Variability
Fondazione Don Carlo Gnocchi ETS
Other
Effects of Continuous Chest Wall Vibration on Dyspnea and Exercise Tolerance in COPD Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03927820
Asthma, Bronchial Diseases
Nashville, Tennessee, United States
View Trial DetailsNCT06614959
Bronchial Diseases, Bronchitis
Montreal, Quebec, Canada
View Trial DetailsNCT04754490
COPD, Chronic Disease
Abercynon, Wales, United Kingdom
View Trial DetailsNCT06336252
Arthritis, Basal Ganglia Diseases
Copenhagen, Denmark
View Trial Details