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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Subjects hospitalized for a COPD acute exacerbation, undergoing arterial blood gas analysis, evaluation of presence and grade of dyspnea, handgrip strength test, and diaphragmatic and vastus lateralis muscle ultrasound assessment, at admission and discharge. | ||
| B | Subjects referred for pulmonary rehabilitation (PR) after a hospitalized COPD exacerbation, undergoing pulmonary function test, arterial blood gas analysis, evaluation of presence and grade of dyspnea, handgrip strength test, and diaphragmatic and vastus lateralis muscle ultrasound assessment, before and after PR. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria (Group A):
Exclusion Criteria:
Inclusion Criteria (Group B):
Exclusion Criteria:
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Group A: Subjects hospitalizated for a COPD acute exacerbation Group B: Subjects referred for pulmonary rehabilitation (PR) after a hospitalized COPD exacerbation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vittoria Conti, PhD | Contact | 0039 338 2163293 | vittoria.conti@sanraffaele.it |
| Name | Affiliation | Role |
|---|---|---|
| Vittoria Conti, PhD | Unit of Pulmonay Rehabilitation, IRCCS San Raffaele Pisana | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16219454 | Background | 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. | |
| 10985606 | Background | 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. |
| Label | URL |
|---|---|
| GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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 |
| 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) |
| 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) |
| 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) |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |