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TerminatedNCT03153826AMI-EX-BPCOUpdated Dec 21, 2021

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

An interventional study of Comparison of clinical and biological characteristics of patients in Chronic Obstructive Pulmonary Disease (COPD), Exacerbation Copd and Muscle Atrophy, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-12-21.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Basic science

Why this study was terminated
Lack of patient recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
40 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • COPD Exacerbation
  • Muscle atrophy
  • Inflammation
  • Oxidative stress
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 9 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria:

  • Concomitant cardiac event
  • Tracheal intubation
  • Chronic respiratory disease other than COPD
  • Disease of locomotor apparatus, neurological or psychiatrics comorbidities
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Other
    Patients

    Other: Comparison of clinical and biological characteristics of patients

Interventions

  • OtherComparison 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Second day after hospitalization and discharge

  2. 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

    Time frame: Fifth day after hospitalization and discharge

  3. 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

    Time frame: Eigth day after hospitalization and discharge

Secondary outcomes

  1. 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

    Time frame: Second, fifth, and eighth day after hospitalization and discharge

07

Study locations

1 site
  • Montpellier University Hospital Arnaud de Villeneuve Hospital
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03153826
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
May 15, 2017
Start date
May 10, 2017
Primary completion
Jan 15, 2019
Completion
Jan 15, 2019
Last update
Dec 21, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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