COPDSARCOBSNCT03111849
Sarcopenia in COPD Patients: a French Study
An observational study of COPD, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The prevalence of sarcopenia is high in many organ pathologies such as COPD, but remains little studied in acute respiratory failure. Sarcopenia is a health problem representative of frailty, loss of autonomy and decreased muscle strength. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- sarcopenia
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 30 Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic obstructive patients
Who may be able to join
- Age ≥ 18 years
- A history of persistent airflow obstruction (a post-bronchodilator FEV1/FVC < 0.7 of the predicted value after 400 ug of inhaled salbutamol) compatible with respiratory function tests (according to the GOLD definition)
- Informed consent to examination of nutritional status
Who cannot join
- Bronchopulmonary cancer being treated
- Disabling rheumatic disease
- Recent stroke or surgery (< 3 months)
- Missing data on essential variables (BMI, mid-arm muscle circumference)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Sarcopenia in Chronic Obstructive Patients Hospitalized in Pneumology at the CHU of Clermont-Ferrand
The prevalence of sarcopenia is high in many organ pathologies such as COPD, but remains little studied in acute respiratory failure. Sarcopenia is a health problem representative of frailty, loss of autonomy and decreased muscle strength. The frequency and evolution of sarcopenia is unknown in patients having chronic bronchic obstruction with exacerbation.
Read the detailed description
- Investigator consecutively included patients with known persistent airflow obstruction, hospitalized in Pneumology Department at the CHU Gabriel Montpied in Clermont-Ferrand.
- Investigator offered to participate to an observational study involving nutritional evaluation (recommended by national and international authorities) complementary to their usual respiratory care, and a 6 months' follow-up consultation: examination and surveys, mid-arm muscle circumference, body composition, spirometry.
- This enables to assess sarcopenia as a low mid-arm muscle area, by measuring the mid-arm muscle circumference of the dominant side and the triceps skinfold thickness.
- The primary endpoint is to determine the prevalence of sarcopenia, via the brachial muscular circumference, of chronic obstructive patients hospitalized in Pneumology department.
- The data entry (clinical, biological and radiological) is carried out on site, during the initial consultation and follow-up, directly on the computerized patient file. These data will then be retrieved and entered in an Excel spreadsheet, anonymously (anonymous identification number, gender and age).
- Management of censored data (lost to follow-up, cessation or withdrawal of study): each patient has a "computerized patient record" with phone numbers, checked during the first consultation and updated if necessary. The patient is called back one month before the follow-up consultation to confirm the appointment. If it is impossible to come, the patient will be offered another appointment, within one month of his initial appointment.
- Lost participants will not be excluded from statistical analyses.
- The expected number of subjects is 50.
- Oral and written consent is asked at the beginning of the consultation proposing participation in the study and follow-up at 6 months.
- Conditions
- COPD
- Being tested
- sarcopenia
- Keywords
- COPD, Sarcopenia, Prevalence, Mortality, Malnutrition, Nutritional assessment, Body composition, Pulmonary cachexia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sarcopenia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarcopeniaOther
Prevalence of sarcopenia in hospitalized chronic obstructive patients
| Study group | Role | What they receive |
|---|---|---|
| hospitalized chronic obstructive patients | Not described Receives: Other: sarcopenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sarcopenia in hospitalized chronic obstructive patients
Measured: at day 1
Secondary outcomes (3)
Evolution of sarcopenia after hospitalization
Measured: at day 1
Determination of the factors influencing this evolution
Measured: at day 1
Determination of phenotypes from anthropometric, functional and nutritional biological parameters
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startJan 2017
- Primary completion31 Oct 2017
- Study completion30 Nov 2017
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annick GREIL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111849
- Sponsor's protocol ID
- CHU-315
- Other IDs
- IRB00008526
- Acronym
- SARCOBS
- Status last verified
- Jul 2018
- First submitted
- 7 Apr 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sarcopenia in Chronic Obstructive Patients Hospitalized in Pneumology at the CHU of Clermont-Ferrand
- ClinicalTrials.gov ID
- NCT03111849
- Acronym / sponsor ID
- SARCOBS / CHU-315
- Conditions
- COPD
- Keywords
- COPD, Sarcopenia, Prevalence, Mortality, Malnutrition, Nutritional assessment, Body composition, Pulmonary cachexia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 13 Apr 2017 (actual)
- 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.
The prevalence of sarcopenia is high in many organ pathologies such as COPD, but remains little studied in acute respiratory failure. Sarcopenia is a health problem representative of frailty, loss of autonomy and decreased muscle strength. The frequency and evolution of sarcopenia is unknown in patients having chronic bronchic obstruction with exacerbation.
Detailed description
- Investigator consecutively included patients with known persistent airflow obstruction, hospitalized in Pneumology Department at the CHU Gabriel Montpied in Clermont-Ferrand.
- Investigator offered to participate to an observational study involving nutritional evaluation (recommended by national and international authorities) complementary to their usual respiratory care, and a 6 months' follow-up consultation: examination and surveys, mid-arm muscle circumference, body composition, spirometry.
- This enables to assess sarcopenia as a low mid-arm muscle area, by measuring the mid-arm muscle circumference of the dominant side and the triceps skinfold thickness.
- The primary endpoint is to determine the prevalence of sarcopenia, via the brachial muscular circumference, of chronic obstructive patients hospitalized in Pneumology department.
- The data entry (clinical, biological and radiological) is carried out on site, during the initial consultation and follow-up, directly on the computerized patient file. These data will then be retrieved and entered in an Excel spreadsheet, anonymously (anonymous identification number, gender and age).
- Management of censored data (lost to follow-up, cessation or withdrawal of study): each patient has a "computerized patient record" with phone numbers, checked during the first consultation and updated if necessary. The patient is called back one month before the follow-up consultation to confirm the appointment. If it is impossible to come, the patient will be offered another appointment, within one month of his initial appointment.
- Lost participants will not be excluded from statistical analyses.
- The expected number of subjects is 50.
- Oral and written consent is asked at the beginning of the consultation proposing participation in the study and follow-up at 6 months.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hospitalized chronic obstructive patients | – | Other: sarcopenia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic obstructive patients
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- A history of persistent airflow obstruction (a post-bronchodilator FEV1/FVC < 0.7 of the predicted value after 400 ug of inhaled salbutamol) compatible with respiratory function tests (according to the GOLD definition)
- Informed consent to examination of nutritional status
Key exclusion criteria (4 listed)
- Bronchopulmonary cancer being treated
- Disabling rheumatic disease
- Recent stroke or surgery (< 3 months)
- Missing data on essential variables (BMI, mid-arm muscle circumference)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sarcopeniaPrevalence of sarcopenia in hospitalized chronic obstructive patients | Other | hospitalized chronic obstructive patients |
Primary outcome
Prevalence of sarcopenia in hospitalized chronic obstructive patients
Time frame: at day 1
3 secondary outcomes
Evolution of sarcopenia after hospitalization
Time frame: at day 1
Determination of the factors influencing this evolution
Time frame: at day 1
Determination of phenotypes from anthropometric, functional and nutritional biological parameters
Time frame: at day 1
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 26 Jul 2018.
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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.
Annick GREIL principal investigator
University Hospital, Clermont-Ferrand
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 University Hospital, Clermont-Ferrand 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 3 inclusion and 4 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 26 Jul 2018. 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?
Prevalence of sarcopenia in hospitalized chronic obstructive patients (time frame: at day 1). 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 26 Jul 2018.