Continuous Chest Wall Vibration in COPD Rehabilitation

Not Applicable

Completed

• Conditions: COPD

• Registration Number: NCT03644888
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-23
• Study Start: 2018-09-12
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 Sympatho-vagal balance	Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks	Heart Rate Variability
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 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

Trial Locations

Locations (1)

Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza; 🇮🇹 Rovato, Brescia, Italy