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Completed

NCT Number: NCT03644888

Continuous Chest Wall Vibration in COPD Rehabilitation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza

Rovato, Brescia, 25038, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cycle ergometer training

Other

Already in arm/group descriptions

Airway clearance program

Other

Already in arm/group descriptions

Vibration therapy

Device

Already in arm/group descriptions

Sham vibration therapy

Device

Already in arm/group descriptions

Primary outcomes

  1. Change of Dyspnea

    Time frame: 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

  2. Change of exercise tolerance

    Time frame: 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

Secondary outcomes

  1. Change of respiratory muscles strength

    Time frame: 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

  2. Change of Risk of death

    Time frame: 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)

  3. Change of Health-related quality of life

    Time frame: 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

  4. Change of Sympatho-vagal balance

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

    Heart Rate Variability

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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