Ultrasonographic Evaluation of Diaphragm and Quadriceps in Chronic Obstructive Pulmonary Disease (COPD) Patients

COPD Clinical Trial

— EDIFEB  

Official title:

Echographic Characteristics of DIaphragm and FEmoral Quadriceps in COPD Patients: Evaluation of Their Relationship With the Lung Function Impairment and the Effect of Pulmonary Rehabilitation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04509128
• Other study ID #: RP 19/19
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: April 2024

Study information

• Verified date: June 2023
• Source: IRCCS San Raffaele Roma
• Contact: Vittoria Conti, PhD
• Phone: 0039 338 2163293
• Email: vittoria.conti[@]sanraffaele.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the prognostic role of echographic diaphragmatic assessment and vastus lateralis muscle ultrasound (US) in two independent populations of patients hospitalized for exacerbated Chronic Obstructive Pulmonary Disease (COPD) or undergoing pulmonary rehabilitation.

Specific aims of this protocol are: 1) to analyze the correlation between qualitative and quantitative US parameters and severity of illness indicators and respiratory function data; 2) to detect the postrehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function, assessed by US, and the correlation between these outcomes and indicators of pulmonary rehabilitation treatment effectiveness; 3) to evaluate the ability of qualitative and quantitative US parameters to predict in-hospital mortality and length of stay; 4) to evaluate the ability of qualitative and quantitative US parameters to predict exacerbation rate, hospitalization rate and mortality rate six months after the discharge.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria (Group A):

• COPD diagnosis

• previous or actual cigarette smoking history

• COPD exacerbation requiring hospitalization

• Obtained written informed consent

Exclusion Criteria:

• Pleural effusion extended for more than two intercostal spaces

• Interstitial lung diseases

• Major surgery in the previous 30 days

• Right pleurodesis or fibrothorax

• Right stroke outcomes

• Technical impossibility to perform ultrasound evaluations

• conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons

• Absence of written informed consent

Inclusion Criteria (Group B):

• COPD diagnosis

• previous or actual cigarette smoking history

• COPD exacerbation requiring hospitalization in the previous 30 days

• Indication to undergo a pulmonary rehabilitation protocol

• Obtained written informed consent

Exclusion Criteria:

• Pleural effusion extended for more than two intercostal spaces

• Interstitial lung diseases

• Major surgery in the previous 30 days

• Right pleurodesis or fibrothorax

• Right stroke outcomes

• Technical impossibility to perform ultrasound evaluations

• conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons

• Absence of written informed consent

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele Roma

References & Publications (26)

Arora NS, Rochester DF. Effect of body weight and muscularity on human diaphragm muscle mass, thickness, and area. J Appl Physiol Respir Environ Exerc Physiol. 1982 Jan;52(1):64-70. doi: 10.1152/jappl.1982.52.1.64. — View Citation

Bolton CE, Bevan-Smith EF, Blakey JD, Crowe P, Elkin SL, Garrod R, Greening NJ, Heslop K, Hull JH, Man WD, Morgan MD, Proud D, Roberts CM, Sewell L, Singh SJ, Walker PP, Walmsley S; British Thoracic Society Pulmonary Rehabilitation Guideline Development Group; British Thoracic Society Standards of Care Committee. British Thoracic Society guideline on pulmonary rehabilitation in adults. Thorax. 2013 Sep;68 Suppl 2:ii1-30. doi: 10.1136/thoraxjnl-2013-203808. No abstract available. — View Citation

Cesari M, Landi F, Calvani R, Cherubini A, Di Bari M, Kortebein P, Del Signore S, Le Lain R, Vellas B, Pahor M, Roubenoff R, Bernabei R, Marzetti E; SPRINTT Consortium. Rationale for a preliminary operational definition of physical frailty and sarcopenia in the SPRINTT trial. Aging Clin Exp Res. 2017 Feb;29(1):81-88. doi: 10.1007/s40520-016-0716-1. Epub 2017 Feb 10. — View Citation

Cesari M, Pedone C, Chiurco D, Cortese L, Conte ME, Scarlata S, Incalzi RA. Physical performance, sarcopenia and respiratory function in older patients with chronic obstructive pulmonary disease. Age Ageing. 2012 Mar;41(2):237-41. doi: 10.1093/ageing/afr167. Epub 2011 Dec 8. No abstract available. — View Citation

Crimi C, Heffler E, Augelletti T, Campisi R, Noto A, Vancheri C, Crimi N. Utility of ultrasound assessment of diaphragmatic function before and after pulmonary rehabilitation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2018 Oct 8;13:3131-3139. doi: 10.2147/COPD.S171134. eCollection 2018. — View Citation

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13. — View Citation

Decramer M, De Benedetto F, Del Ponte A, Marinari S. Systemic effects of COPD. Respir Med. 2005 Dec;99 Suppl B:S3-10. doi: 10.1016/j.rmed.2005.09.010. Epub 2005 Oct 10. — View Citation

Decramer M, Lacquet LM, Fagard R, Rogiers P. Corticosteroids contribute to muscle weakness in chronic airflow obstruction. Am J Respir Crit Care Med. 1994 Jul;150(1):11-6. doi: 10.1164/ajrccm.150.1.8025735. — View Citation

Iwasawa T, Takahashi H, Ogura T, Asakura A, Gotoh T, Shibata H, Inoue T. Influence of the distribution of emphysema on diaphragmatic motion in patients with chronic obstructive pulmonary disease. Jpn J Radiol. 2011 May;29(4):256-64. doi: 10.1007/s11604-010-0552-8. Epub 2011 May 24. — View Citation

Koerts-de Lang E, Schols AM, Rooyackers OE, Gayan-Ramirez G, Decramer M, Wouters EF. Different effects of corticosteroid-induced muscle wasting compared with undernutrition on rat diaphragm energy metabolism. Eur J Appl Physiol. 2000 Aug;82(5-6):493-8. doi: 10.1007/s004210000231. — View Citation

Marquis K, Debigare R, Lacasse Y, LeBlanc P, Jobin J, Carrier G, Maltais F. Midthigh muscle cross-sectional area is a better predictor of mortality than body mass index in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2002 Sep 15;166(6):809-13. doi: 10.1164/rccm.2107031. — View Citation

Martinez CH, Diaz AA, Meldrum CA, McDonald MN, Murray S, Kinney GL, Hokanson JE, Curtis JL, Bowler RP, Han MK, Washko GR, Regan EA; COPDGene Investigators. Handgrip Strength in Chronic Obstructive Pulmonary Disease. Associations with Acute Exacerbations and Body Composition. Ann Am Thorac Soc. 2017 Nov;14(11):1638-1645. doi: 10.1513/AnnalsATS.201610-821OC. — View Citation

McLean RR, Shardell MD, Alley DE, Cawthon PM, Fragala MS, Harris TB, Kenny AM, Peters KW, Ferrucci L, Guralnik JM, Kritchevsky SB, Kiel DP, Vassileva MT, Xue QL, Perera S, Studenski SA, Dam TT. Criteria for clinically relevant weakness and low lean mass and their longitudinal association with incident mobility impairment and mortality: the foundation for the National Institutes of Health (FNIH) sarcopenia project. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):576-83. doi: 10.1093/gerona/glu012. — View Citation

Montes de Oca M, Torres SH, Gonzalez Y, Romero E, Hernandez N, Mata A, Talamo C. Peripheral muscle composition and health status in patients with COPD. Respir Med. 2006 Oct;100(10):1800-6. doi: 10.1016/j.rmed.2006.01.020. Epub 2006 Mar 20. — View Citation

Podnar S, Harlander M. Phrenic nerve conduction studies in patients with chronic obstructive pulmonary disease. Muscle Nerve. 2013 Apr;47(4):504-9. doi: 10.1002/mus.23617. Epub 2013 Feb 4. — View Citation

Rochester DF. The diaphragm: contractile properties and fatigue. J Clin Invest. 1985 May;75(5):1397-402. doi: 10.1172/JCI111841. No abstract available. — View Citation

Rodrigues FM, Demeyer H, Loeckx M, Hornikx M, Van Remoortel H, Janssens W, Troosters T. Health status deterioration in subjects with mild to moderate airflow obstruction, a six years observational study. Respir Res. 2019 May 18;20(1):93. doi: 10.1186/s12931-019-1061-7. — View Citation

Sabino PG, Silva BM, Brunetto AF. Nutritional status is related to fat-free mass, exercise capacity and inspiratory strength in severe chronic obstructive pulmonary disease patients. Clinics (Sao Paulo). 2010 Jun;65(6):599-605. doi: 10.1590/S1807-59322010000600007. — View Citation

Scarlata S, Mancini D, Laudisio A, Benigni A, Antonelli Incalzi R. Reproducibility and Clinical Correlates of Supine Diaphragmatic Motion Measured by M-Mode Ultrasonography in Healthy Volunteers. Respiration. 2018;96(3):259-266. doi: 10.1159/000489229. Epub 2018 Aug 16. — View Citation

Scarlata S, Mancini D, Laudisio A, Raffaele AI. Reproducibility of diaphragmatic thickness measured by M-mode ultrasonography in healthy volunteers. Respir Physiol Neurobiol. 2019 Feb;260:58-62. doi: 10.1016/j.resp.2018.12.004. Epub 2018 Dec 13. — View Citation

Singanayagam A, Schembri S, Chalmers JD. Predictors of mortality in hospitalized adults with acute exacerbation of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2013 Apr;10(2):81-9. doi: 10.1513/AnnalsATS.201208-043OC. — View 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. — View Citation

Thurlbeck WM. Diaphragm and body weight in emphysema. Thorax. 1978 Aug;33(4):483-7. doi: 10.1136/thx.33.4.483. — View Citation

Ticinesi A, Meschi T, Narici MV, Lauretani F, Maggio M. Muscle Ultrasound and Sarcopenia in Older Individuals: A Clinical Perspective. J Am Med Dir Assoc. 2017 Apr 1;18(4):290-300. doi: 10.1016/j.jamda.2016.11.013. Epub 2017 Feb 13. — View Citation

Ticinesi A, Narici MV, Lauretani F, Nouvenne A, Colizzi E, Mantovani M, Corsonello A, Landi F, Meschi T, Maggio M. Assessing sarcopenia with vastus lateralis muscle ultrasound: an operative protocol. Aging Clin Exp Res. 2018 Dec;30(12):1437-1443. doi: 10.1007/s40520-018-0958-1. Epub 2018 Apr 26. — View Citation

Zanforlin A, Giannuzzi R, Nardini S, Testa A, Soldati G, Copetti R, Marchetti G, Valente S, Inchingolo R, Smargiassi A. The role of chest ultrasonography in the management of respiratory diseases: document I. Multidiscip Respir Med. 2013 Aug 9;8(1):54. doi: 10.1186/2049-6958-8-54. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between diaphragmatic and vastus lateralis muscle function and severity of illness indicators and respiratory function data	Evaluation of the correlation between qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters and the degree of respiratory function impairment	At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Primary	Variations of diaphragmatic and vastus lateralis muscle function, assessed by US, after 4 weeks of in-hospital Pulmonary Rehabilitation	Evaluation of the post rehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function	After 4 weeks of Pulmonary Rehabilitation (T1)
Primary	Relationship between post rehabilitation changes in diaphragmatic and vastus lateralis muscle function and indicators of pulmonary rehabilitation treatment effectiveness	Evaluation of the correlation between post rehabilitation qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters and indicators of pulmonary rehabilitation treatment effectiveness (mMRC, Modified Medical Research Council, Dyspnea Scale; distance in meters at six minute walking test; respiratory function data; arterial blood gas values)	After 4 weeks of Pulmonary Rehabilitation (T1)
Secondary	Prediction of in-hospital mortality by means of parameters of diaphragmatic and vastus lateralis muscle function	Evaluation of the ability of qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters to predict in-hospital mortality	At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Secondary	Prediction of length of stay by means of parameters of diaphragmatic and vastus lateralis muscle function	Evaluation of the ability of qualitative and quantitative diaphragmatic and vastus lateralis muscle ultrasound parameters to predict length of stay	At discharge from hospital, estimated average of 10 days for Group A patients, and 28 days for Group B patients
Secondary	Prediction of COPD exacerbation rate by means of parameters of diaphragmatic and vastus lateralis muscle function	Evaluation the ability of qualitative and quantitative US parameters to predict COPD exacerbation rate six months after the discharge	Six months after discharge (T2)
Secondary	Prediction of hospitalization rate by means of parameters of diaphragmatic and vastus lateralis muscle function	Evaluation the ability of qualitative and quantitative US parameters to predict hospitalization rate six months after the discharge	Six months after discharge (T2)
Secondary	Prediction of mortality rate by means of parameters of diaphragmatic and vastus lateralis muscle function	Evaluation the ability of qualitative and quantitative US parameters to predict mortality rate six months after the discharge	Six months after discharge (T2)

External Links

•   GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines