NCT04543929.

Study name	Effects of innovative aerobic exercise training in cystic fibrosis
Methods	Design: single‐centre, open‐label, parallel‐design RCT; no blinding Location: University of Kansas Medical Center, USA Duration: 12 weeks
Participants	Enrolment goal: 9 participants with CF Inclusion criteria: diagnosis of CF; prescribed and taking for 28 days ivacaftor‐tezacaftor‐elexacaftor (Trikafta); aged ≥ 18 years Exclusion criteria: aged ≤ 17 years; not eligible for ivacaftor‐tezacaftor‐elexacaftor (Trikafta); inability to exercise; pregnancy; status after lung transplantation; already participating in > 150 min of aerobic exercise per week
Interventions	This study evaluates the effectiveness of standard of care therapy plus exercise compared to standard of care only for improving cardiorespiratory fitness. Intervention group: partially supervised and home‐based exercise training (exercise prescription plus standard of care) Control group: standard of care (no exercise prescription)
Outcomes	Primary outcome  Change in aerobic exercise capacity at the anaerobic threshold via submaximal CPET, measured at baseline and after 12 weeks Secondary outcomes Change in FEV1, measured at baseline and after 12 weeks Change in quality of life (CFQ‐R), measured at baseline and after 12 weeks Change in sweat chloride concentration, measured at baseline and after 12 weeks Change in HbA1c concentration, measured at baseline and after 12 weeks
Starting date	11 February 2020
Contact information	University of Kansas Medical Center, Kansas City, Kansas, USA Christine Morgan: telephone: 00 1 913‐588‐1572; Email: cmorgan6@kumc.edu    Larry Scott: telephone: 00 1 913‐588‐1572; Email: lscott2@kumc.edu
Notes	The primary outcome is broadly defined and not clear to the authors of this review.