LBM & Lung Function in Adolescents With CF

March 11, 2020 updated by: King's College Hospital NHS Trust

Nutritional Status and Pulmonary and Respiratory Muscle Function in Children and Young People With Cystic Fibrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

29

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

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation School

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

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and young people with confirmed CF, between 12 years and 18 will be studied.

Description

Inclusion Criteria:

  • Confirmed diagnosis of CF
  • Ages 12-19

Exclusion Criteria:

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

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association between body mass index (BMI) & lean body mass (LBM) with pulmonary & respiratory muscle function
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between exercise tolerance and pulmonary & respiratory muscle function
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

King's College Hospital NHS Trust

Collaborators

King's College London

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)

June 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCH16-074

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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