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Measurements of Diaphragmatic Mobility on COPD Patients

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
Casa Di Cura Villa Serena SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pulmonary Disease, Chronic Obstructive focused on measuring Ultrasonography, Respiratory Function Tests, Pulmonary Disease, Chronic Obstructive, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Casa di Cura Villa Serena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

COPD patients

Control

Arm Description

COPD patients submitted to Pulmonary Rehabilitation according to the ATS/ERS statement.

Healthy individuals who will undergo the same COPD's evaluation protocol. As "healthy individuals" they will not participate to the Pulmonary Rehabilitation.

Outcomes

Primary Outcome Measures

Diaphragmatic mobility
diaphragmatic craniocaudal displacement on centimeters (performed on M-mode, mobility measured on centimeters)

Secondary Outcome Measures

Lung function (Spirometry)
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),
Lung function (Body plethysmography)
Total Lung capacity (liters), Total gas volume (liters), Residual volume (liters).
Lung function (gas exchange)
measurements of carbon monoxide lung diffusion (DLCO) on milliliters/minute/millimeters of mercury.
Functional status (Six minute walking test)
measurement of the distance walked (in meters) on six minutes
measurements of arterial blood gas
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)

Full Information

First Posted
June 30, 2016
Last Updated
August 9, 2017
Sponsor
Casa Di Cura Villa Serena SpA
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1. Study Identification

Unique Protocol Identification Number
NCT02838953
Brief Title
Measurements of Diaphragmatic Mobility on COPD Patients
Official Title
Diaphragmatic Mobility, Lung Hyperinflation and Effects of the Pulmonary Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Casa Di Cura Villa Serena SpA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Ultrasonography, Respiratory Function Tests, Pulmonary Disease, Chronic Obstructive, Rehabilitation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD patients
Arm Type
Experimental
Arm Description
COPD patients submitted to Pulmonary Rehabilitation according to the ATS/ERS statement.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy individuals who will undergo the same COPD's evaluation protocol. As "healthy individuals" they will not participate to the Pulmonary Rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diaphragmatic mobility
Description
diaphragmatic craniocaudal displacement on centimeters (performed on M-mode, mobility measured on centimeters)
Time Frame
up to four weeks
Secondary Outcome Measure Information:
Title
Lung function (Spirometry)
Description
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),
Time Frame
up to four weeks
Title
Lung function (Body plethysmography)
Description
Total Lung capacity (liters), Total gas volume (liters), Residual volume (liters).
Time Frame
up to four weeks
Title
Lung function (gas exchange)
Description
measurements of carbon monoxide lung diffusion (DLCO) on milliliters/minute/millimeters of mercury.
Time Frame
up to four weeks
Title
Functional status (Six minute walking test)
Description
measurement of the distance walked (in meters) on six minutes
Time Frame
up to four weeks
Title
measurements of arterial blood gas
Description
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)
Time Frame
up to four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilo Corbellini, PhD
Organizational Affiliation
Respiratory Physiotherapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casa di Cura Villa Serena
City
Piossasco
ZIP/Postal Code
10098
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21810710
Citation
Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008.
Results Reference
background
PubMed Identifier
24127811
Citation
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 Molken 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.
Results Reference
background
PubMed Identifier
9279231
Citation
Cassart M, Pettiaux N, Gevenois PA, Paiva M, Estenne M. Effect of chronic hyperinflation on diaphragm length and surface area. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):504-8. doi: 10.1164/ajrccm.156.2.9612089.
Results Reference
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PubMed Identifier
22878278
Citation
Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
Results Reference
background
PubMed Identifier
19017880
Citation
Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.
Results Reference
result
PubMed Identifier
30065081
Citation
Corbellini C, Boussuges A, Villafane JH, Zocchi L. Diaphragmatic Mobility Loss in Subjects With Moderate to Very Severe COPD May Improve After In-Patient Pulmonary Rehabilitation. Respir Care. 2018 Oct;63(10):1271-1280. doi: 10.4187/respcare.06101. Epub 2018 Jul 31.
Results Reference
derived

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Measurements of Diaphragmatic Mobility on COPD Patients

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