Extrapulmonary Effects of Cystic Fibrosis on Physical Activity of Adult Patients.

NCT01848392 | Completed

• 1 other identifier: 2011 - A00819 - 32
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis; Adults; Physical activity

Outcome Measures

Primary Outcomes (2)

• Steps per day

  The armband indicates the mean number of steps per day over a 7-day period

  Day 7

• Physical activity level

  The investigators determine the physical activity level by dividing total daily energy expenditure by whole-night sleeping energy expenditure

  Day 7

Study Arms (1)

physical activity CF cohort

adult patients with CF at time of their yearly assessment at Cochin adult CF centre

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with CF cared at Cochin adult CF centre, Paris

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

Related Publications (3)

• 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.

  PMID: 18715878 BACKGROUND

• Tejero 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.

  PMID: 21292759 BACKGROUND

• Watz 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.

  PMID: 18048807 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Study Officials

• Dominique Hubert, MD

  Université Paris-Centre, AP-HP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 7, 2013
• Study Start: February 21, 2013
• Primary Completion: July 30, 2014
• Study Completion: March 30, 2016
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)