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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02080936
Other study ID # FVIE_M2W
Secondary ID
Status Completed
Phase N/A
First received March 5, 2014
Last updated March 6, 2014
Start date January 2014
Est. completion date March 2014

Study information

Verified date March 2014
Source 5 Santé
Contact n/a
Is FDA regulated No
Health authority France: Ministère de l'Enseignement supérieur et de la Recherche
Study type Observational

Clinical Trial Summary

Peripheral muscle mass and strength are relevant indicators of COPD survival. Current guidelines recommend to assess muscle strength only in muscle wasted patients. However, a recent study reported quadriceps weakness without muscle wasting (Menon, M et al. Resp. Res.2012, 13:119). Thus, these guidelines raise the risk to miss out some weak patients. In clinical settings, fat-free-mass index (FFMI) is indicated as a simple index to assess muscle wasting. We aimed at determining the prevalence of patients entering in pulmonary rehabilitation (PR) a priori not eligible for muscle strength evaluation given the lack of muscle wasting clinical signs.


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who have got FFMI (bioimpedance)

- Patients who have done quadriceps muscle strenght evaluation

Exclusion Criteria:

- Patients without FFMI

- Patients without quadriceps muscle strenght

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Clinique du Souffle La Vallonie Lodeve

Sponsors (1)

Lead Sponsor Collaborator
5 Santé

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle wasting in COPD patient baseline No
Secondary Muscle weakness in COPD patient baseline No
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