Status:
TERMINATED
A CFit Study - Acute Exercise
Lead Sponsor:
University of Portsmouth
Collaborating Sponsors:
Queen Alexandra Hospital, Portsmouth
University Hospital Southampton NHS Foundation Trust
Conditions:
Cystic Fibrosis
Cystic Fibrosis-related Diabetes
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
A great medical success is the increase in the median survival age associated with cystic fibrosis (CF). However, this success has led to a new era of research aiming to maximise the quality of life (...
Detailed Description
Participants and recruitment The present study will be a pilot, counter-balanced, cross-over trial in individuals with CF (n = 16). Furthermore, the present protocol is an extension of the CFit\_BL pr...
Eligibility Criteria
Inclusion
- Males and females ≥ 12 years of age
- CF diagnosis based on clinical features, supported by an abnormal sweat test (sweat chloride \> 60 mmol·L-1 \> 100 mg sweat) and, where possible, diagnostic genotyping
- No contraindications to performing exhaustive exercise
- Can understand and cooperate with the study protocol
- No increase in symptoms or weight loss in the preceding 2 weeks
Exclusion
- 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
- Exclusion during testing:
- Onset of acute infection
- Becomes and/or is tested to be pregnant following enrolment to the study
- Experiences significant hypoxaemia during visit 2 of the CFit\_BL protocol (IRAS ID: 225310) which requires supplemental O₂. Under these circumstances, participants will be invited to continue their participation under the CFit\_BL trial (IRAS ID: 225310)
- Unable to understand or cooperate with study protocol
- The individual does not wish to participate further
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03237767
Start Date
May 1 2018
End Date
December 1 2020
Last Update
April 28 2021
Active Locations (1)
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1
Department of Sport and Exercise Science
Portsmouth, Hampshire, United Kingdom, PO1 2ER