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Measurements of Diaphragmatic Mobility on COPD Patients

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ClinicalTrials.gov Identifier: NCT02838953
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Casa Di Cura Villa Serena SpA

Brief Summary:

To determine whether the COPD impairs the diaphragmatic mobility (DM), and verify improvements after an inpatient pulmonary rehabilitation (PR).

Ultrasonography on M-mode will assess the diaphragmatic mobility at rest breathing and at slow deep inspiration. Lung functions test, arterial blood gas analyses, six minute walk test will be also performed, on COPD patients and healthy subjects.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: Pulmonary Rehabilitation Not Applicable

Detailed Description:

The diaphragm pathophysiological changes occurring in chronic obstructive pulmonary disease (COPD) leads to functional inefficiency that strongly correlates to the loss of lung function. Muscle fiber shortening follows lung hyperinflation, resulting to a chronic mechanical disadvantage, which worsens in COPD exacerbations. The DM is mostly assessed with techniques that exposes the patient to risks. The ultrasonography on M-mode is easy to use, safe and measures directly the diaphragmatic dome displacement. The study aim to determine whether the COPD impairs the DM, and verify improvements after an inpatient PR.

Every COPD patient will comprise a standard evaluation that consists on lung function test, six minute walk test and arterial blood gas analyses, according to the American Thoracic Society/ European Respiratory Society (ATS/ERS) statements.

Within the second day of recovery the diaphragm mobility ultrasonographic (US) measurement will be assessed as follow: the patients positioned in a semi recumbent position (45 degrees).The US probe positioned between the anterior and mean axillary line, on the central right subcostal area, cranial and dorsal. The US wave perpendicularly on the posterior hemidiaphragm third (it is visualized as the hyperechogenic line behind the liver). The mobility assessed by M-mode while the patient breaths on tidal volume (rest breathing) and deep slow breathing (to Functional Residual Capacity).

The COPD patients classification and diagnosis will be according to the the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. Every patient, after the assessment will follow the PR as ATS/ERS statement on pulmonary rehabilitation. All patients will follow a routine of five days a week of physical exercise. The rehabilitation program consists on a 30 minutes calisthenic gymnastic once a day, 20 minutes of cycloergometer training activity twice a day. The aerobic cycloergometer training was set at 60%-70% of the maximum cardiac frequency determined by 220 minus the patients age. The patients will perform lower limbs strengths exercises, especially for the quadriceps and hamstring. During the in-hospital stay, the patients will receive regular prescribed medication and oxygen therapy according to the medical staff evaluation, which will be prescribed by the clinician in charge. The patients will also have respiratory physiotherapy, regarding the presence of lung secretion retain, and the need to expand unventilated areas.

The control group will be composed by healthy volunteers. The volunteers will be screened on their lung function. The subjects on the control group will be submitted to the same evaluation protocol regarding the spirometry and the M-mode ultrasonography.

Statistical analyses:

The qualitative description of the data will be made with percentages and frequency. The quantitative data described as means and standard deviation for the symmetrical distributions. The Kolmogorov-Smirnov test to determine distributions mean normality. A One-way analysis of variance (ANOVA) with repeated measurements and Bonferroni test will be used as post-hoc test to evaluate statistical significance. Within-group effect sizes will be calculated using the Cohen d coefficient interpretation. For all the study data, the P values lower than 0.05 will be consider significant. The investigators will use the Student T- test for independent sample for quantitative data and for comparisons between the COPD patients and control group and ANOVA to the comparisons within COPD group. The investigators will use Pearson's correlation test to measure the correlation between the diaphragmatic mobility and the lung functioning variables.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Diaphragmatic Mobility, Lung Hyperinflation and Effects of the Pulmonary Rehabilitation
Study Start Date : March 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: COPD patients
COPD patients submitted to Pulmonary Rehabilitation according to the ATS/ERS statement.
Behavioral: Pulmonary Rehabilitation
Comprehensive intervention based on a thorough patient assessment followed by patient- tailored therapies that include, but are not limited to, exercise training, education, and behavior change, designed to improve the physical and psychological condition of people with chronic respiratory disease and to promote the long-term adherence to health-enhancing behaviors.

No Intervention: Control
Healthy individuals who will undergo the same COPD's evaluation protocol. As "healthy individuals" they will not participate to the Pulmonary Rehabilitation.



Primary Outcome Measures :
  1. Diaphragmatic mobility [ Time Frame: up to four weeks ]
    diaphragmatic craniocaudal displacement on centimeters (performed on M-mode, mobility measured on centimeters)


Secondary Outcome Measures :
  1. Lung function (Spirometry) [ Time Frame: up to four weeks ]
    measurements of Forced vital capacity (liters), Forced expiratory volume on the first second (liters), expiratory reserve volume (liters), Inspiratory capacity (liters), Vital capacity (liters), Inspiratory reserve volume (liters), Tidal Volume (liters),

  2. Lung function (Body plethysmography) [ Time Frame: up to four weeks ]
    Total Lung capacity (liters), Total gas volume (liters), Residual volume (liters).

  3. Lung function (gas exchange) [ Time Frame: up to four weeks ]
    measurements of carbon monoxide lung diffusion (DLCO) on milliliters/minute/millimeters of mercury.

  4. Functional status (Six minute walking test) [ Time Frame: up to four weeks ]
    measurement of the distance walked (in meters) on six minutes

  5. measurements of arterial blood gas [ Time Frame: up to four weeks ]
    arterial blood sampling to measure hydrogenic potential (Ph), arterial oxygen pressure (PaO2), arterial carbonic anhydride pressure (PaCO2), bicarbonate (HCO3). PaO2, PaCO2 and HCO3 are measured on millimeters of mercury (mmHg)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Clinical Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Informed consent signature

Exclusion Criteria:

  • Subjects with Pneumothorax
  • Subjects with Active hemoptyses
  • Subjects with Acute heart failure
  • Subjects with Systemic arterial hypertension
  • Subjects with aortic aneurism
  • Subjects who underwent Hepatic surgery
  • Subjects who underwent Splenectomy surgery
  • Subjects with Diaphragmatic paralysis Subjects with Neuromuscular diseases Subjects with Chronic orthopaedic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838953


Locations
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Italy
Casa di Cura Villa Serena
Piossasco, Italy, 10098
Sponsors and Collaborators
Casa Di Cura Villa Serena SpA
Investigators
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Principal Investigator: Camilo Corbellini, PhD Respiratory Physiotherapist

Publications of Results:
Other Publications:
Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Mölken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST. Erratum in: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Casa Di Cura Villa Serena SpA
ClinicalTrials.gov Identifier: NCT02838953     History of Changes
Other Study ID Numbers: Clinicavillaserena
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Casa Di Cura Villa Serena SpA:
Ultrasonography
Respiratory Function Tests
Pulmonary Disease, Chronic Obstructive
Rehabilitation

Additional relevant MeSH terms:
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Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive