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LBM & Lung Function in Adolescents With CF

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ClinicalTrials.gov Identifier: NCT02797912
Recruitment Status : Unknown
Verified June 2016 by King's College Hospital NHS Trust.
Recruitment status was:  Recruiting
First Posted : June 14, 2016
Last Update Posted : June 28, 2016
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Brief Summary:
In patients with cystic fibrosis (CF) the commonest cause of death is respiratory failure. Respiratory failure can have many causes. However, in patients with CF a major contributor is the impairment of the muscles required for breathing (respiratory muscles). Respiratory muscle impairment can result from poor nutrition. Lung function declines particularly during adolescence whilst body composition also changes at the same time. Thus, the investigators plan to study the relationship of nutrition and body composition to respiratory muscle strength and lung function in children and young people with CF aged between 12-18 years. The body mass index (BMI) is currently used in the clinical setting to measure nutritional status in CF. At King's College Hospital (KCH) there are portable devices to assess both respiratory muscle function and lung function. The research team will use a Bioelectrical Impedance Analysis (BIA) device to assess body composition, including BMI and lean body mass (LBM). The aim of the study is primarily to assess whether measurements of LBM impairment may better relate to poor lung function compared to BMI and secondly to examine whether lung and respiratory muscle function correlates with exercise tolerance.

Condition or disease Intervention/treatment
Cystic Fibrosis Other: No intervention

Detailed Description:

In patients with Cystic Fibrosis (CF) the commonest cause of death is respiratory failure. Respiratory failure can have many causes. However, in patients with CF a major contributor is the impairment of the muscles required for breathing (respiratory muscles). Respiratory muscle impairment can result from severe narrowing of the airways, poor nutrition, chronic infection and inflammation, lack of aerobic exercise and use of steroids (Dassios, 2015). The most rapid decline in lung function is seen during adolescence and coincides with a change in body composition (Loomba-Albrecht, 2009). The body mass index (BMI) is currently used in the clinical setting to quantify nutritional status in CF. However, measurements of the proportion of lean muscle, such as lean body mass (LBM), may better describe nutritional impairment in CF (Pedreira, 2005, Ionescu, 1998). LBM and BMI have been measured using dual x-ray absorptiometry (DXA) in children and young adults with CF showing a stronger association of LBM rather than BMI with pulmonary function especially in the undernourished adolescent (Sheikh, 2014). Assessment of respiratory muscle function and body composition has previously required specialised equipment, such as DXA, which is not readily available in many CF clinics. In addition, DXA involves radiation which may have unwanted side effects if used routinely for body composition monitoring. At King's College Hospital there are now, however, portable devices to assess both respiratory muscle function and body composition. The investigators will use a Bioelectrical Impedance Analysis (BIA) device to calculate body composition, including BMI and LBM. The aim of the study is primarily to assess whether LBM rather than BMI better predicts both pulmonary and respiratory muscle function using portable equipment that avoids use of avoidable radiation. Secondly, the research team aims to examine whether pulmonary and respiratory muscle function correlates to exercise capacity. These may yield useful information about targeting nutritional support and exercise to improve respiratory muscle and pulmonary function.

A cross-sectional study will be undertaken. Age, height, and weight will be recorded. Spirometry, impulse oscillometry and body plethysmography will be measured with a pneumotachograph based system (Jaeger Masterscreen PFT, Carefusion Ltd, Basingstoke UK) according to the American Thoracic Society and the European Respiratory Society guidelines. The highest value of forced vital capacity (FVC), forced expiratory volume in one second (FEV1), ratio of FEV1 to VC (FEV1/VC), forced expiratory flow between 25 and 75% of VC (FEF 25-75%), functional residual capacity (FRC), residual volume (RV), total lung capacity (TLC), respiratory system resistance at 5Hz and 20Hz (Rrs5, Rrs20) will be recorded following at least three technically acceptable measurements. Respiratory muscle function data will be obtained from the Micro RPM Respiratory Muscle Analyser (CareFusion, San Diego, California, USA): maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), sniff nasal inspiratory pressure (SNIP), maximum relaxation rate (MRR), time constant of relaxation (τ, tau), and maximum rate of pressure development (MRPD). A respiratory health questionnaire will be completed. Body composition information will be obtained with the Inbody S10 Body Composition Analyzer (Inbody Ltd, Cerritos, California, USA): Body mass index (BMI), BMI-z scores, fat free mass (FFM), segmental lean mass (LM) [LM-right arm (LMRA), LM-left arm (LMLA), LM-trunk (LMTR), LM-right leg (LMRL), LM-left leg (LMLL)], visceral fat area (VFA), body cell mass (BCM). A field test to assess exercise tolerance test will be performed and the level of habitual activity will be assessed using a questionnaire. Information will be collected on genetic mutations, chronic infection status, use of systemic corticosteroids, and co-morbidities.


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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Nutritional Status and Pulmonary and Respiratory Muscle Function in Children and Young People With Cystic Fibrosis
Study Start Date : June 2016
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort Intervention/treatment
CF children and young people
Observational study involving clinical procedures: lung function testing, respiratory muscle strength testing, body composition analysis & exercise tolerance.
Other: No intervention



Primary Outcome Measures :
  1. Association between body mass index (BMI) & lean body mass (LBM) with pulmonary & respiratory muscle function [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Association between exercise tolerance and pulmonary & respiratory muscle function [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and young people with confirmed CF, between 12 years and 18 will be studied.
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of CF
  • Ages 12-18

Exclusion Criteria:

  • Acute illness or hospitalisation that would render the participants unable to undertake the assessment, including pulmonary exacerbation in past 2-weeks,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797912


Contacts
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Contact: Niovi Papalexopoulou 0044 (0) 7722590977 niovi.papalexopoulou@nhs.net
Contact: Anne Greenough 0044 (0) 2032993037 anne.greenough@kcl.ac.uk

Locations
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United Kingdom
King's College Hospital NHS Foundation School Recruiting
London, United Kingdom, SE5 9RS
Contact: Niovi Papalexopoulou, MBBS, BA    0044 (0) 7722590977    niovi.papalexopoulou@nhs.net   
Contact: Anne Greenough, MD, MBBS, DCH, FRCP,    0044 (0)2032993037    anne.greenough@kcl.ac.uk   
Sponsors and Collaborators
King's College Hospital NHS Trust
King's College London

Publications:
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02797912     History of Changes
Other Study ID Numbers: KCH16-074
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016

Keywords provided by King's College Hospital NHS Trust:
pulmonary function
respiratory muscle function
body composition
exercise tolerance

Additional relevant MeSH terms:
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Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases