Fitness, Body Composition, Physical Activity and Sleep Patterns in People With Cystic Fibrosis on Modulator Therapy.

NCT05857709 | Unknown

• 1 other identifier: 313567
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cystic fibrosis (CF) is the most common inherited condition in the United Kingdom, affecting approximately 10,837 people. It is well recognised that regular exercise is clinically important for people with CF. Exercise function measured by the maximal oxygen consumption during a cardiopulmonary exercise test is often reduced in people with CF and this has been attributed to multiple factors including, altered heart and blood vessel function, muscle function, reduced physical activity levels and poorer sleep quality. New medicine (modulators) have become available for many people with CF. Modulators appear able to reduce sweat chloride concentrations, improve lung function and reduce the frequency of pulmonary exacerbations in people with CF. Little evidence exists to show how they may have changed the fitness and underlying mechanisms responsible for this in people with CF. This study aims to:

1. 1.determine the exercise function
2. 2.determine the blood vessel function
3. 3.determine body composition
4. 4.determine physical activity and sleep levels in people with CF on modulator therapy compared to a healthy controls group.

Conditions

Cystic Fibrosis

Keywords

Exercise; Modulator therapy; Peripheral muscle function; Vascular function; Body composition; Physical activity

Outcome Measures

Primary Outcomes (1)

• Maximal oxygen uptake

  Between group differences in maximal oxygen uptake derived from a maximal cardiopulmonary exercise testing on a cycle ergometer

  Day 1 - baseline

Secondary Outcomes (24)

• Peak minute ventilation

  Day 1 - baseline

• Oxygen uptake at the gas exchange threshold

  Day 1 - baseline

• Peak power output

  Day 1 - baseline

• Time to exhaustion

  Day 1 - baseline

• Heart rate

  Day 1 - baseline

Study Arms (2)

Cystic fibrosis

No intervention - only assessments.

Healthy Control

No intervention - only assessments.

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from adult and paediatric CF outpatient clinics within the Southampton CF network.

You may qualify if:

• Stable on the modulator therapy, Kaftrio®
• Males and females ≥ 10 years of age
• CF diagnosis based on clinical features, supported by a history of an abnormal sweat test (sweat chloride \> 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 exercise
• Can understand and cooperate with the study protocol
• No increase in symptoms or weight loss in the preceding 2 weeks
• Healthy males and females who are age- 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 and cardiovascular disease.
• 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
• Are taking vasoactive medications
• Any pulmonary, metabolic or cardiovascular conditions
• Any other diagnosed disease
• Any non-pulmonary conditions that may impair exercise ability, such as musculoskeletal disorders and cardiovascular disease
• Is pregnant during the initial screening procedure
• Presents with co-morbidities to performing exhaustive exercise
• Is a smoker or inhales any other substance
• Unable to understand or cooperate with the study protocol due to learning difficulties or otherwise
• Not an age- 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: January 23, 2023
• First Posted: May 15, 2023
• Study Start: January 10, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)