Continuous Chest Wall Vibration in COPD Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Continuous Chest Wall Vibration on Dyspnea and Exercise Tolerance in COPD Patients

Conditions
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COPD

Intervention / Treatment
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* Other: Cycle ergometer training
* Other: Airway clearance program
* Device: Vibration therapy
* Device: Sham vibration therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Cycle ergometer training program: 2 minutes warm-up at no load, 20 minutes at 60% of peak work (PW) calculated by stress-test or at 50% of PW calculated according to Luxton equation (PW = 103.217 + (30.50 X gender) + (-1.613 X age) + (0.002 X 6MWW [m kg -1 ]). The progression of the workloads is calculated according to the BORG Dyspnea and Fatigue Scale (Borg D and F < 5: 10W increase; Borg D and/or F between 5 e 6: maintain same workload; Borg D and / or > 6: 10W decrease) Patient tailored airway clearance program guided by an experienced respiratory physical therapist, which could includes active cycle of breathing technique (ACBT), forced expiratory technique (FET), ELTGOL (slow expiration with glottis open in the lateral position) and PEP techniques (positive expiratory pressure). | Other: Cycle ergometer training<br>* Already in arm/group descriptions<br>Other: Airway clearance program<br>* Already in arm/group descriptions<br>|
| Experimental: Experimental group<br>Cycle ergometer training program plus application of vibration therapy. The vibration is provided at 150Hz via 4 effectors applied bilaterally at the second or third interspaces in the parasternal region of the upper chest wall and at the seventh to ninth interspaces anterior to the midaxillary line in the lower chest wall. | Other: Cycle ergometer training<br>* Already in arm/group descriptions<br>Other: Airway clearance program<br>* Already in arm/group descriptions<br>Device: Vibration therapy<br>* Already in arm/group descriptions<br>|
| Sham Comparator: Sham intervention group<br>Cycle ergometer training program plus application of sham vibration therapy: 4 effectors on chest-wall at same position of vibration therapy, the device that produces vibration is switched on, producing the typical noise and vibration is emitted by effectors not placed on the patient but left in place on the device. | Other: Cycle ergometer training<br>* Already in arm/group descriptions<br>Other: Airway clearance program<br>* Already in arm/group descriptions<br>Device: Sham vibration therapy<br>* Already in arm/group descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Dyspnea | 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 from Baseline Barthel Index based on dyspnea at 4 weeks | 
| Change of exercise tolerance | 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 | Change from Baseline exercise tolerance at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of respiratory muscles strength | 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 from Baseline respiratory muscles strength at 4 weeks | 
| Change of Risk of death | 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 from Baseline risk of death at 4 weeks | 
| Change of Health-related quality of life | 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 from Baseline health-related quality at 4 weeks | 
| Change of Sympatho-vagal balance | Heart Rate Variability | Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Vibration, Rehabilitation