Extrapulmonary Effects of Cystic Fibrosis on Physical Activity of Adult Patients. (MUCO-DAP)

July 31, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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).

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.

Study Overview

Status

Completed

Conditions

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:

  1. quality of life CFQ14+ questionnaire
  2. hospital anxiety depression (HAD) scale validated in French
  3. Baecke physical activity questionnaire

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
physical activity CF cohort
adult patients with CF at time of their yearly assessment at Cochin adult CF centre

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steps per day
Time Frame: Day 7
The armband indicates the mean number of steps per day over a 7-day period
Day 7
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
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Dominique Hubert, MD, Université Paris-Centre, AP-HP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2013

Primary Completion (Actual)

July 30, 2014

Study Completion (Actual)

March 30, 2016

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011 - A00819 - 32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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