Continuous Chest Wall Vibration in COPD Rehabilitation

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644888
• Other study ID #: Vibra_COPD_FDG
• Status: Completed
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2020
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Cycle ergometer training
Already in arm/group descriptions
• Airway clearance program
Already in arm/group descriptions

Device:
• Vibration therapy
Already in arm/group descriptions
• Sham vibration therapy
Already in arm/group descriptions

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza	Rovato	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (11)

Bausewein C, Booth S, Gysels M, Higginson I. Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005623. doi: 10.1002/14651858.CD005623.pub2. Review. Update in: Cochrane Database Syst Rev. 2013;11:CD005623. — View Citation

Binks AP, Bloch-Salisbury E, Banzett RB, Schwartzstein RM. Oscillation of the lung by chest-wall vibration. Respir Physiol. 2001 Jul;126(3):245-9. — View Citation

Bolser DC, Lindsey BG, Shannon R. Respiratory pattern changes produced by intercostal muscle/rib vibration. J Appl Physiol (1985). 1988 Jun;64(6):2458-62. — View Citation

Burke D, Hagbarth KE, Löfstedt L, Wallin BG. The responses of human muscle spindle endings to vibration during isometric contraction. J Physiol. 1976 Oct;261(3):695-711. — View Citation

Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. Review. — View Citation

Casale R, Ring H, Rainoldi A. High frequency vibration conditioning stimulation centrally reduces myoelectrical manifestation of fatigue in healthy subjects. J Electromyogr Kinesiol. 2009 Oct;19(5):998-1004. doi: 10.1016/j.jelekin.2008.08.002. Epub 2008 Sep 26. — View Citation

Cristiano LM, Schwartzstein RM. Effect of chest wall vibration on dyspnea during hypercapnia and exercise in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 May;155(5):1552-9. — View Citation

Fallon JB, Macefield VG. Vibration sensitivity of human muscle spindles and Golgi tendon organs. Muscle Nerve. 2007 Jul;36(1):21-9. — View Citation

Nakayama H, Shibuya M, Kaneko N, Yamada M, Suzuki H, Arakawa M, Homma I. Benefit of in-phase chest wall vibration on the pulmonary hemodynamics in patients with chronic obstructive pulmonary disease. Respirology. 1998 Dec;3(4):235-40. — View Citation

Nakayama H, Shibuya M, Yamada M, Suzuki H, Arakawa M, Homma I. In-phase chest wall vibration decreases dyspnea during arm elevation in chronic obstructive pulmonary disease patients. Intern Med. 1998 Oct;37(10):831-5. — View Citation

Sibuya M, Yamada M, Kanamaru A, Tanaka K, Suzuki H, Noguchi E, Altose MD, Homma I. Effect of chest wall vibration on dyspnea in patients with chronic respiratory disease. Am J Respir Crit Care Med. 1994 May;149(5):1235-40. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change of Sympatho-vagal balance	Heart Rate Variability	Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks