Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of COPD (AMI-EX-BPCO)

Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of strength and muscle mass) is one of comorbidities affecting 30% to 60% of patients and playing a key role in their prognosis. Indeed, several studies have shown muscle weakness during hospitalization for exacerbation of COPD by measure of maximal voluntary contraction of quadriceps (MVCQ), but the results are variable from one patient to another. Moreover, no study was interested in the change of muscle mass in patients hospitalized for an exacerbation of COPD. Several mechanisms have been mentioned but not demonstrated: systemics factors (initial amyotrophy, inflammation, oxidative stress, corticotherapy, hypoxia…) but also physical inactivity. In this context, identifying factors associated with the onset of muscle weakness during hospitalization for exacerbation of COPD is a necessary step to better understand the mechanisms and consider a personalized therapeutic approach that can improve the functional and clinical prognosis of disease.

The primary outcome is to identify the clinical and biological determinants associated with the onset of amyotrophy (Measure by ultrasound of sectional area of the Rectus Femoris, CSARF), during hospitalization for exacerbation of COPD. The secondary outcome is to identify the clinical and biological determinants associated with the onset of MVCQ decrease, during hospitalization for exacerbation of COPD.

120 patients hospitalized for exacerbation of COPD will be recruited in two hospitals (CHU Montpellier - CHU Grenoble, FRANCE). The measures of CSARF and MVCQ are carried out on the second, fifth, eighth day of hospitalization, on discharge and on the sixtieth day after hospitalization. A blood test will be performed on the second day of hospitalization to explore different markers of inflammation and oxydative stress. Moreover, to quantify the level of physical activity (number of steps), each patient will carry a pedometer throughout the duration of hospitalization.

At the end of protocol, two groups will be made from the median of CSARF : patients with a small reduction in CSARF compared to patients with a greater reduction in SSRF between the second and eighth days of hospitalization (or between the second day of hospitalization and discharge). Then clinical (comorbidities, severity disease, initial weakness, initial amyotrophy, usual physical activity before hospitalization, treatment, exacerbation number in the previous year…) and biological (markers of inflammation and oxydative stress) determinants were compared between the two groups.

Thus, the identification of the determinants associated with the onset of amyotrophy induced during exacerbation of COPD will guide research for exploration of physiopathological mechanisms of this muscular dysfunction in the exacerbation of COPD as well as to identify a personalized support.

Study Overview

• Status: Terminated
• Conditions: Muscle Atrophy; Chronic Obstructive Pulmonary Disease (COPD); Exacerbation Copd
• Intervention / Treatment: Other: Comparison of clinical and biological characteristics of patients

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Montpellier University Hospital Arnaud de Villeneuve Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients aged 40 to 85 years
• COPD patients : FEV1/FVC < 70% pred
• Hospitalization for COPD exacerbation : increased respiratory symptoms over two consecutive days with at least one major symptom (dyspnea, increased sputum volume or purity) associated with another major symptom or minor symptom (sibilant, cold, sore throat or cough)

Exclusion criteria:

• Concomitant cardiac event
• Tracheal intubation
• Chronic respiratory disease other than COPD
• Disease of locomotor apparatus, neurological or psychiatrics comorbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients	Other: Comparison of clinical and biological characteristics of patients; Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of clinical and biological characteristics of patients	Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation	Second day after hospitalization and discharge
Comparison of clinical and biological characteristics of patients	Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation	Fifth day after hospitalization and discharge
Comparison of clinical and biological characteristics of patients	Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation	Eigth day after hospitalization and discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of clinical and biological characteristics	Comparison of clinical and biological characteristics of patients with less variation in maximal voluntary contraction of quadriceps (MVCQ) compared to patients with greater variation during an hospitalization for COPD exacerbation	Second, fifth, and eighth day after hospitalization and discharge

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Oxidative stress; Inflammation; Muscle atrophy; COPD Exacerbation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Muscular Atrophy; Atrophy
• Other Study ID Numbers: 9774

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No