Sweat Response, Sweat Composition and Thermoregulatory Response to Exercise in Heat in Adults With Cystic Fibrosis on Modulator Therapy.

NCT05896488 | Unknown

• 1 other identifier: 315193
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic fibrosis (CF) is a common inherited condition in the Caucasian population resulting in poor function and/or production of the CF transmembrane conductance regulator (CFTR) protein. The CFTR protein plays a crucial role in the secretion and re-absorption of sodium chloride within the sweat gland. The sweat gland has played a key role in diagnosing and understanding CF with sweat chloride elevation being a key criterion to diagnosing CF. People with CF are thought to be at risk of exertional heat illness during exposure to hot environments or during prolonged periods of exercise and are currently encouraged to take salt supplements during periods of excessive sweating. Kaftrio®, a newly approved pharmacological therapy has shown a rapid and sustained reduction in sweat chloride levels on initiation of this treatment. This study will aim to play a crucial part in understanding the sweat response, sweat composition and the thermoregulatory response to exercise in the heat in people with CF on Kaftrio®.

Conditions

Cystic Fibrosis

Keywords

Exercise, CFTR modulator therapy, thermoregulation, heat-related illness, sweat sodium

Outcome Measures

Primary Outcomes (1)

• Sweat sodium concentration (mmol∙L-1)

  Between group differences in sweat sodium concentration

  Day 2 - baseline

Secondary Outcomes (16)

• Whole-body sweat rate (mL)

  Day 2 - baseline

• Forearm sweat rate (mg∙min-1∙cm2)

  Day 2 - baseline

• Mid-back sweat rate (mg∙min-1∙cm2)

  Day 2 - baseline

• Sweat gland activity (gland∙cm2)

  Day 2 - baseline

• Core temperature (°C)

  Day 2 - baseline

Study Arms (2)

Cystic fibrosis

No intervention - only assessments

Healthy Control

No intervention- only assessments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from adult CF outpatient clinics within the CF network. If a potential participant outside of the CF network wishes to participant they will be screened by the CF consultants within the CF network.

You may qualify if:

• Is taking CFTRm
• Males and females ≥ 18 years of age
• CF diagnosis based on clinical features, supported by a history of an abnormal sweat test (sweat \[Cl-\] \> 60 mmol·L-1 \> 100 mg sweat), where possible, diagnostic genotyping would also be desired
• Can clearly state that they are not pregnant
• No contraindications to performing exhaustive exercise
• Can understand and cooperate with the study protocol
• No exacerbation (increase in cough, sputum or breathlessness, or change in the colour of sputum) within the preceding 2 weeks
• No weight loss in the preceding 2 weeks
• Healthy males and females who are age- weight- and sex- matched to the enrolled individuals with CF
• Can clearly state that they are not pregnant
• No clinical diagnosis of a chronic disease
• Can understand and cooperate with the study protocol
• No contraindications to performing exhaustive exercise

You may not qualify if:

• Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders (arthritis, joint or muscle disease) and cardiovascular disease (congenital heart disease or cardiomyopathy).
• Unstable co-morbid asthma (daily pulmonary function variability of \>20%)
• Is pregnant during the initial screening process
• Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
• Not of a suitable age for testing
• Is a smoker or inhales any other substances
• Any pulmonary, metabolic or cardiovascular conditions
• Any other diagnosed disease
• Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders (active arthritis, joint or muscle disease) and cardiovascular disease (congenital heart disease or cardiomyopathy)
• Is pregnant during the initial screening process
• Presents with co-morbidities to performing exhaustive exercise
• Is a smoker or inhales any other substances
• Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
• Not an age- weight- or sex-match for the CF group

Sponsors & Collaborators

• University of Portsmouth: lead
• University Hospital Southampton NHS Foundation Trust: collaborator

Study Sites (1)

University of Portsmouth

Portsmouth, PO1 2EF, United Kingdom

RECRUITING

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

Central Study Contacts

Zoe Saynor

CONTACT

02392843080; zoe.saynor@port.ac.uk

Lauren Clayton

CONTACT

02392843085; lauren.clayton@port.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader (Associate Professor) in Clinical Exercise Physiology

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: March 18, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: June 9, 2023

Record last verified: 2023-05

Locations

GB (1)