NCT02080936

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

March 5, 2014

Last Update Submit

March 6, 2014

Conditions

COPD

Keywords

Experimental approachesPeripheral muscle KeywordRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Muscle wasting in COPD patient

    baseline

Secondary Outcomes (1)

  • Muscle weakness in COPD patient

    baseline

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients from "Clinique du Souffle La vallonie" and "Clinique du Souffle La Solane"

You may qualify if:

  • Patients who have got FFMI (bioimpedance)
  • Patients who have done quadriceps muscle strenght evaluation

You may not qualify if:

  • Patients without FFMI
  • Patients without quadriceps muscle strenght

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique du Souffle La Vallonie

Lodève, 34700, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 7, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations

FR(1)