Continuous Chest Wall Vibration in COPD Rehabilitation

NCT03644888 | Completed

• 1 other identifier: Vibra_COPD_FDG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; Vibration; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change of respiratory muscles strength

  Change from Baseline respiratory muscles strength at 4 weeks

• Change of Risk of death

  Change from Baseline risk of death at 4 weeks

• Change of Health-related quality of life

  Change from Baseline health-related quality at 4 weeks

• Change of Sympatho-vagal balance

  Change from Baseline sympatho-vagal balance at 2 weeks and at 4 weeks

Study Arms (3)

Control group

ACTIVE COMPARATOR

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; Other: Airway clearance program

Experimental group

EXPERIMENTAL

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; Other: Airway clearance program; Device: Vibration therapy

Sham intervention group

SHAM COMPARATOR

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; Other: Airway clearance program; Device: Sham vibration therapy

Interventions

Cycle ergometer training OTHER

Already in arm/group descriptions

Control group; Experimental group; Sham intervention group

Airway clearance program OTHER

Already in arm/group descriptions

Control group; Experimental group; Sham intervention group

Vibration therapy DEVICE

Already in arm/group descriptions

Experimental group

Sham vibration therapy DEVICE

Already in arm/group descriptions

Sham intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- COPD diagnosis (GOLD stage: 2-3-4)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza

Rovato, Brescia, 25038, Italy

Location

Related Publications (12)

• 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.

  PMID: 11403786 BACKGROUND

• 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.

  PMID: 3403429 BACKGROUND

• 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.

  PMID: 135841 BACKGROUND

• 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.

  PMID: 12562163 BACKGROUND

• 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.

  PMID: 9154856 BACKGROUND

• 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.

  PMID: 17471568 BACKGROUND

• 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.

  PMID: 18819821 BACKGROUND

• 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.

  PMID: 10201049 BACKGROUND

• 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.

  PMID: 9840703 BACKGROUND

• 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.

  PMID: 8173764 BACKGROUND

• 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.

  PMID: 18425927 BACKGROUND

• 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.

  PMID: 33781780 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Riccardo Buraschi, DPT

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 23, 2018
• Study Start: September 12, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

IT (1)