LBM & Lung Function in Adolescents With CF

NCT02797912 | Completed

• 1 other identifier: KCH16-074
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

pulmonary function; respiratory muscle function; body composition; exercise tolerance

Outcome Measures

Primary Outcomes (1)

• Association between body mass index (BMI) & lean body mass (LBM) with pulmonary & respiratory muscle function

  4 months

Secondary Outcomes (1)

• Association between exercise tolerance and pulmonary & respiratory muscle function

  4 months

Study Arms (1)

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

Interventions

No intervention OTHER

CF children and young people

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Confirmed diagnosis of CF
• Ages 12-19

You may not qualify if:

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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital NHS Foundation School

London, SE5 9RS, United Kingdom

Location

Related Publications (5)

• Dassios T. Determinants of respiratory pump function in patients with cystic fibrosis. Paediatr Respir Rev. 2015 Jan;16(1):75-9. doi: 10.1016/j.prrv.2014.01.001. Epub 2014 Jan 28.

  PMID: 24661942 BACKGROUND

• Loomba-Albrecht LA, Styne DM. Effect of puberty on body composition. Curr Opin Endocrinol Diabetes Obes. 2009 Feb;16(1):10-5. doi: 10.1097/med.0b013e328320d54c.

  PMID: 19115520 BACKGROUND

• Pedreira CC, Robert RG, Dalton V, Oliver MR, Carlin JB, Robinson P, Cameron FJ. Association of body composition and lung function in children with cystic fibrosis. Pediatr Pulmonol. 2005 Mar;39(3):276-80. doi: 10.1002/ppul.20162.

  PMID: 15668934 BACKGROUND

• Ionescu AA, Chatham K, Davies CA, Nixon LS, Enright S, Shale DJ. Inspiratory muscle function and body composition in cystic fibrosis. Am J Respir Crit Care Med. 1998 Oct;158(4):1271-6. doi: 10.1164/ajrccm.158.4.9710079.

  PMID: 9769291 BACKGROUND

• Sheikh S, Zemel BS, Stallings VA, Rubenstein RC, Kelly A. Body composition and pulmonary function in cystic fibrosis. Front Pediatr. 2014 Apr 15;2:33. doi: 10.3389/fped.2014.00033. eCollection 2014.

  PMID: 24783186 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Design

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

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

GB (1)