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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD), Exacerbation Copd, Muscle Atrophy

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Comparison of clinical and biological characteristics of patients
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD Exacerbation, Muscle atrophy, Inflammation, Oxidative stress

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montpellier University Hospital Arnaud de Villeneuve Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients

Arm Description

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2017
Last Updated
December 20, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03153826
Brief Title
Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of COPD
Acronym
AMI-EX-BPCO
Official Title
Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of patient recruitment
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD), Exacerbation Copd, Muscle Atrophy
Keywords
COPD Exacerbation, Muscle atrophy, Inflammation, Oxidative stress

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Comparison of clinical and biological characteristics of patients
Intervention Description
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
Primary Outcome Measure Information:
Title
Comparison of clinical and biological characteristics of patients
Description
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
Time Frame
Second day after hospitalization and discharge
Title
Comparison of clinical and biological characteristics of patients
Description
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
Time Frame
Fifth day after hospitalization and discharge
Title
Comparison of clinical and biological characteristics of patients
Description
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
Time Frame
Eigth day after hospitalization and discharge
Secondary Outcome Measure Information:
Title
Comparison of clinical and biological characteristics
Description
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
Time Frame
Second, fifth, and eighth day after hospitalization and discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Montpellier University Hospital Arnaud de Villeneuve Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of COPD

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