Cystic FibrosisMUCO-DAPNCT01848392
Extrapulmonary Effects of Cystic Fibrosis on Physical Activity of Adult Patients.
An observational study of Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Physical activity seems to be a prognostic factor for quality of life and survival in patients with cystic fibrosis (CF). Whereas their exercise capacity has been assessed through medical examination, their daily physical activity has been little studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2013to 30 Mar 2016
- 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: Adult patients with CF cared at Cochin adult CF centre, Paris
Who may be able to join
- Patients with CF (positive sweat test or 2 disease causing CFTR mutations)
- Aged 18 or older
- Regularly cared at Cochin adult CF centre
- In clinical stable status
Who cannot join
- Pulmonary exacerbation in the 4 previous weeks
- IV antibiotic course for pulmonary exacerbation in the 2 previous weeks
- Pregnancy in female patients
- Patient with history of lung transplantation
- Patient on a waiting list for lung transplantation
- Treatment of diabetes initiated for less than 3 months
- Enteral nutrition initiated for less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extra Pulmonary Determinants of Physical Activity in Adults With Cystic Fibrosis.
Physical activity seems to be a prognostic factor for quality of life and survival in patients with cystic fibrosis (CF). Whereas their exercise capacity has been assessed through medical examination, their daily physical activity has been little studied. Activity monitors have measured physical activity only in a few studies which considered mainly respiratory status and more recently bone mineral density and body composition. Determinants of physical activity in patients with CF remain largely unknown.
The objective of this study is to measure daily physical activity with activity monitors in adult patients with CF and to investigate the determinants of physical activity, with a focus on extra-respiratory factors (nutritional status, diabetes, bone mineralization, anxiety and/or depression, cardiac impairment).
Read more
Seventy adult patients with CF, regularly cared at the Cochin adult CF centre, will be recruited in a stable period during their annual review. During this assessment, laboratory tests will be carried out (especially parameters for nutritional status), as well as measurement of body composition and bone mineral density, respiratory function tests and a 6 minute walk test, and echocardiography. Patients will wear for 7 consecutive days a multi-sensor armband SenseWear on the arm, to assess the intensity of physical activity in metabolic equivalents (METS) and steps per day. Finally, patients will complete three self-administered questionnaires: Quality of Life (CFQ14 +), hospital anxiety depression scale and physical activity.
After a descriptive analysis of the study cohort, we will study qualitative and quantitative criteria related to physical activity (assessed quantitatively by the number of steps/day or metabolic equivalents).
Linear regression models will then be developed to assess the independent factors associated with physical activity, adjusting for different variables of interest related to patients demographic, behavioral, clinical (respiratory and non-respiratory ) and biological parameters. Conversely, the "predictive" independent aspect of physical activity will be studied according to respiratory function, nutritional status and quality of life.
Read the detailed description
Ambulatory adult CF patients are recruited at time of their yearly evaluation.
Phenotypic patients' characteristics Age, gender, CFTR genotype, pancreatic status (presence or absence of exocrine pancreatic insufficiency), number of IV antibiotic courses and number of hospitalization over the previous year, are reported.
Physical activity measurement Physical activity is measured over 7 consecutive days using a multisensor armband (SenseWear Pro Armband; BodyMedia, Inc.,Pittsburgh, PA) that is worn on the upper right arm over the triceps muscle. It incorporates a biaxial accelerometer that records steps per day, and physiologic indicators of energy expenditure that enable the investigator to determine the physical activity level.
Evaluation of respiratory function and cardiovascular status Patients will perform a respiratory function test to evaluate FVC and FEV1 and six minutes walk test. Arterial blood gases will be done at the beginning and at the end of walk and the walking distance will be indicated in meters.
Echocardiography will be performed to look for left or right cardiac dysfunction and measure systolic pulmonary artery pressure. N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) will be used as a systemic biomarker of heart failure.
Bone mineral density (BMD) and body composition They are measured by X-ray absorptiometry (DEXA) on the lumbar spine, femur and whole body, and measurement of lean and fat mass (Lunar Prodigy).
Nutritional evaluation Weight and height are measured and body mass index (BMI) is calculated. As part of the annual dietary assessment, there will be an evaluation of the amount of ingested nitrogen.
Blood will be drawn to measure: albumin, prealbumin, vitamin E, vitamin A and vitamin 25(OH)D3, HbA1c. C-reactive protein and fibrinogen will be measured as indicators of inflammation.
Urinalysis will measure: creatinine, nitrogen and 3-methylhistidine. Oral glucose tolerance test will be performed (fasting blood glucose and blood glucose 2 hours after ingesting 75 g of glucose) in pancreatic insufficient patients with unknown diabetes.
Self-administered questionnaires
Patients will answer 3 questionnaires:
- quality of life CFQ14+ questionnaire
- hospital anxiety depression (HAD) scale validated in French
- Baecke physical activity questionnaire
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Adults, Physical activity
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| physical activity CF cohort | adult patients with CF at time of their yearly assessment at Cochin adult CF centre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps per day
The armband indicates the mean number of steps per day over a 7-day period
Measured: Day 7
Physical activity level
The investigators determine the physical activity level by dividing total daily energy expenditure by whole-night sleeping energy expenditure
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study start21 Feb 2013
- Primary completion30 Jul 2014
- Study completion30 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Dominique Hubert, MD, Principal investigator, Université Paris-Centre, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848392
- Sponsor's protocol ID
- 2011 - A00819 - 32
- Acronym
- MUCO-DAP
- Status last verified
- Oct 2025
- First submitted
- 3 May 2013
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Troosters T, Langer D, Vrijsen B, Segers J, Wouters K, Janssens W, Gosselink R, Decramer M, Dupont L. Skeletal muscle weakness, exercise tolerance and physical activity in adults with cystic fibrosis. Eur Respir J. 2009 Jan;33(1):99-106. doi: 10.1183/09031936.00091607. Epub 2008 Aug 20.
PubMed 18715878Tejero Garcia S, Giraldez Sanchez MA, Cejudo P, Quintana Gallego E, Dapena J, Garcia Jimenez R, Cano Luis P, Gomez de Terreros I. Bone health, daily physical activity, and exercise tolerance in patients with cystic fibrosis. Chest. 2011 Aug;140(2):475-481. doi: 10.1378/chest.10-1508. Epub 2011 Feb 3.
PubMed 21292759Watz H, Waschki B, Boehme C, Claussen M, Meyer T, Magnussen H. Extrapulmonary effects of chronic obstructive pulmonary disease on physical activity: a cross-sectional study. Am J Respir Crit Care Med. 2008 Apr 1;177(7):743-51. doi: 10.1164/rccm.200707-1011OC. Epub 2007 Nov 29.
PubMed 18048807
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra Pulmonary Determinants of Physical Activity in Adults With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT01848392
- Acronym / sponsor ID
- MUCO-DAP / 2011 - A00819 - 32
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Adults, Physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 21 Feb 2013 (actual)
- Primary completion
- 30 Jul 2014 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 7 May 2013 (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.
Physical activity seems to be a prognostic factor for quality of life and survival in patients with cystic fibrosis (CF). Whereas their exercise capacity has been assessed through medical examination, their daily physical activity has been little studied. Activity monitors have measured physical activity only in a few studies which considered mainly respiratory status and more recently bone mineral density and body composition. Determinants of physical activity in patients with CF remain largely unknown.
The objective of this study is to measure daily physical activity with activity monitors in adult patients with CF and to investigate the determinants of physical activity, with a focus on extra-respiratory factors (nutritional status, diabetes, bone mineralization, anxiety and/or depression, cardiac impairment).
Seventy adult patients with CF, regularly cared at the Cochin adult CF centre, will be recruited in a stable period during their annual review. During this assessment, laboratory tests will be carried out (especially parameters for nutritional status), as well as measurement of body composition and bone mineral density, respiratory function tests and a 6 minute walk test, and echocardiography. Patients will wear for 7 consecutive days a multi-sensor armband SenseWear on the arm, to assess the intensity of physical activity in metabolic equivalents (METS) and steps per day. Finally, patients will complete three self-administered questionnaires: Quality of Life (CFQ14 +), hospital anxiety depression scale and physical activity.
After a descriptive analysis of the study cohort, we will study qualitative and quantitative criteria related to physical activity (assessed quantitatively by the number of steps/day or metabolic equivalents).
Linear regression models will then be developed to assess the independent factors associated with physical activity, adjusting for different variables of interest related to patients demographic, behavioral, clinical (respiratory and non-respiratory ) and biological parameters. Conversely, the "predictive" independent aspect of physical activity will be studied according to respiratory function, nutritional status and quality of life.
Detailed description
Ambulatory adult CF patients are recruited at time of their yearly evaluation.
Phenotypic patients' characteristics Age, gender, CFTR genotype, pancreatic status (presence or absence of exocrine pancreatic insufficiency), number of IV antibiotic courses and number of hospitalization over the previous year, are reported.
Physical activity measurement Physical activity is measured over 7 consecutive days using a multisensor armband (SenseWear Pro Armband; BodyMedia, Inc.,Pittsburgh, PA) that is worn on the upper right arm over the triceps muscle. It incorporates a biaxial accelerometer that records steps per day, and physiologic indicators of energy expenditure that enable the investigator to determine the physical activity level.
Evaluation of respiratory function and cardiovascular status Patients will perform a respiratory function test to evaluate FVC and FEV1 and six minutes walk test. Arterial blood gases will be done at the beginning and at the end of walk and the walking distance will be indicated in meters.
Echocardiography will be performed to look for left or right cardiac dysfunction and measure systolic pulmonary artery pressure. N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) will be used as a systemic biomarker of heart failure.
Bone mineral density (BMD) and body composition They are measured by X-ray absorptiometry (DEXA) on the lumbar spine, femur and whole body, and measurement of lean and fat mass (Lunar Prodigy).
Nutritional evaluation Weight and height are measured and body mass index (BMI) is calculated. As part of the annual dietary assessment, there will be an evaluation of the amount of ingested nitrogen.
Blood will be drawn to measure: albumin, prealbumin, vitamin E, vitamin A and vitamin 25(OH)D3, HbA1c. C-reactive protein and fibrinogen will be measured as indicators of inflammation.
Urinalysis will measure: creatinine, nitrogen and 3-methylhistidine. Oral glucose tolerance test will be performed (fasting blood glucose and blood glucose 2 hours after ingesting 75 g of glucose) in pancreatic insufficient patients with unknown diabetes.
Self-administered questionnaires
Patients will answer 3 questionnaires:
- quality of life CFQ14+ questionnaire
- hospital anxiety depression (HAD) scale validated in French
- Baecke physical activity questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physical activity CF cohort | – | –adult patients with CF at time of their yearly assessment at Cochin adult CF centre |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with CF cared at Cochin adult CF centre, Paris
Key inclusion criteria (4 listed)
- Patients with CF (positive sweat test or 2 disease causing CFTR mutations)
- Aged 18 or older
- Regularly cared at Cochin adult CF centre
- In clinical stable status
Key exclusion criteria (7 listed)
- Pulmonary exacerbation in the 4 previous weeks
- IV antibiotic course for pulmonary exacerbation in the 2 previous weeks
- Pregnancy in female patients
- Patient with history of lung transplantation
- Patient on a waiting list for lung transplantation
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
Steps per day
Time frame: Day 7
The armband indicates the mean number of steps per day over a 7-day period
Physical activity level
Time frame: Day 7
The investigators determine the physical activity level by dividing total daily energy expenditure by whole-night sleeping energy expenditure
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 20 Nov 2025.
- Background: PubMed 18715878Troosters T, Langer D, Vrijsen B, Segers J, Wouters K, Janssens W, Gosselink R, Decramer M, Dupont L. Skeletal muscle weakness, exercise tolerance and physical activity in adults with cystic fibrosis. Eur Respir J. 2009 Jan;33(1):99-106. doi: 10.1183/09031936.00091607. Epub 2008 Aug 20.
- Background: PubMed 21292759Tejero Garcia S, Giraldez Sanchez MA, Cejudo P, Quintana Gallego E, Dapena J, Garcia Jimenez R, Cano Luis P, Gomez de Terreros I. Bone health, daily physical activity, and exercise tolerance in patients with cystic fibrosis. Chest. 2011 Aug;140(2):475-481. doi: 10.1378/chest.10-1508. Epub 2011 Feb 3.
- Background: PubMed 18048807Watz H, Waschki B, Boehme C, Claussen M, Meyer T, Magnussen H. Extrapulmonary effects of chronic obstructive pulmonary disease on physical activity: a cross-sectional study. Am J Respir Crit Care Med. 2008 Apr 1;177(7):743-51. doi: 10.1164/rccm.200707-1011OC. Epub 2007 Nov 29.
- Individual participant dataSharing planned: No
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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.
Dominique Hubert, MD principal investigator
Université Paris-Centre, AP-HP
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 Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 7 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 20 Nov 2025. 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?
Steps per day (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01848392, which also lists 3 linked publications.
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 20 Nov 2025.