Continuous Chest Wall Vibration in COPD Rehabilitation

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Cycle ergometer training; Other: Airway clearance program; Device: Vibration therapy; Device: Sham vibration therapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Brescia
    • Rovato, Brescia, Italy, 25038
      • Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control group; 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; Already in arm/group descriptions; Other: Airway clearance program; Already in arm/group descriptions
EXPERIMENTAL: Experimental group; 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; Already in arm/group descriptions; Other: Airway clearance program; Already in arm/group descriptions; Device: Vibration therapy; Already in arm/group descriptions
SHAM_COMPARATOR: Sham intervention group; 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; Already in arm/group descriptions; Other: Airway clearance program; Already in arm/group descriptions; Device: Sham vibration therapy; Already in arm/group descriptions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

General Publications

• 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. doi: 10.1016/s0034-5687(01)00223-7.
• 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. doi: 10.1152/jappl.1988.64.6.2458.
• Burke D, Hagbarth KE, Lofstedt L, Wallin BG. The responses of human muscle spindle endings to vibration during isometric contraction. J Physiol. 1976 Oct;261(3):695-711. doi: 10.1113/jphysiol.1976.sp011581.
• Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. doi: 10.1097/00003677-200301000-00002.
• 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. doi: 10.1164/ajrccm.155.5.9154856.
• Fallon JB, Macefield VG. Vibration sensitivity of human muscle spindles and Golgi tendon organs. Muscle Nerve. 2007 Jul;36(1):21-9. doi: 10.1002/mus.20796.
• 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.
• 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. doi: 10.1111/j.1440-1843.1998.tb00128.x.
• 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. doi: 10.2169/internalmedicine.37.831.
• 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. doi: 10.1164/ajrccm.149.5.8173764.
• 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.
• Pancera S, Buraschi R, Bianchi LNC, Porta R, Negrini S, Arienti C. Effectiveness of Continuous Chest Wall Vibration With Concurrent Aerobic Training on Dyspnea and Functional Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Aug;102(8):1457-1464. doi: 10.1016/j.apmr.2021.03.006. Epub 2021 Mar 26.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 12, 2018
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (ACTUAL): August 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; COPD; Vibration
• Other Study ID Numbers: Vibra_COPD_FDG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No