NCT02838953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

June 30, 2016

Last Update Submit

August 9, 2017

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

UltrasonographyRespiratory Function TestsPulmonary Disease, Chronic ObstructiveRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic mobility

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

    up to four weeks

Secondary Outcomes (5)

  • Lung function (Spirometry)

    up to four weeks

  • Lung function (Body plethysmography)

    up to four weeks

  • Lung function (gas exchange)

    up to four weeks

  • Functional status (Six minute walking test)

    up to four weeks

  • measurements of arterial blood gas

    up to four weeks

Study Arms (2)

COPD patients

EXPERIMENTAL

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

Behavioral: Pulmonary Rehabilitation

Control

NO INTERVENTION

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

Interventions

Pulmonary RehabilitationBEHAVIORAL

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.

COPD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casa di Cura Villa Serena

Piossasco, 10098, Italy

Location

Related Publications (6)

  • 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.

    PMID: 21810710BACKGROUND

  • 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.

    PMID: 24127811BACKGROUND

  • 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.

    PMID: 9279231BACKGROUND

  • 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.

    PMID: 22878278BACKGROUND

  • 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.

    PMID: 19017880RESULT

  • 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.

    PMID: 30065081DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Camilo Corbellini, PhD

    Respiratory Physiotherapist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 20, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

August 10, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)