COPDM2WNCT02080936
Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD
An observational study of COPD, run by 5 Santé at 1 site in France.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: COPD patients from "Clinique du Souffle La vallonie" and "Clinique du Souffle La Solane"
Who may be able to join
- Patients who have got FFMI (bioimpedance)
- Patients who have done quadriceps muscle strenght evaluation
Who cannot join
- Patients without FFMI
- Patients without quadriceps muscle strenght
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- COPD
- Keywords
- Experimental approaches, Peripheral muscle Keyword, Rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle wasting in COPD patient
Measured: baseline
Secondary outcomes (1)
Muscle weakness in COPD patient
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- 5 Santé
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080936
- Sponsor's protocol ID
- FVIE_M2W
- Acronym
- M2W
- Status last verified
- Mar 2014
- First submitted
- 5 Mar 2014
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Muscle Wasting Always Mean Muscle Weakness? A Prevalence Study in COPD
- ClinicalTrials.gov ID
- NCT02080936
- Acronym / sponsor ID
- M2W / FVIE_M2W
- Conditions
- COPD
- Keywords
- Experimental approaches, Peripheral muscle Keyword, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- 5 SantéUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- COPD patients from "Clinique du Souffle La vallonie" and "Clinique du Souffle La Solane"
Key inclusion criteria (2 listed)
- Patients who have got FFMI (bioimpedance)
- Patients who have done quadriceps muscle strenght evaluation
Key exclusion criteria (2 listed)
- Patients without FFMI
- Patients without quadriceps muscle strenght
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle wasting in COPD patient
Time frame: baseline
1 secondary outcome
Muscle weakness in COPD patient
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by 5 Santé at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle wasting in COPD patient (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2014.