Continuous Chest Wall Vibration in COPD Rehabilitation

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: COPD

Treatments: Other: Airway clearance program; Device: Vibration therapy; Device: Sham vibration therapy; Other: Cycle ergometer training

Study type: Interventional

Funder types: Other

Identifiers

NCT03644888

Vibra_COPD_FDG

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Control group

Active Comparator group

Description:

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).

Treatment:

Other: Airway clearance program

Other: Cycle ergometer training

Experimental group

Experimental group

Description:

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.

Treatment:

Device: Vibration therapy

Other: Airway clearance program

Other: Cycle ergometer training

Sham intervention group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham vibration therapy

Other: Airway clearance program

Other: Cycle ergometer training