NCT00792194.
Methods | Design: parallel RCT; open‐label; duration 24 months; partially‐supervised; single‐centre study at University Hospital, Strasbourg, France. |
Participants | Enrolment goal: 50 participants with CF. Inclusion criteria: males and females aged 15 ‐ 65 years with CF diagnosed by clinical history and positive genetic or sweat testing; signed informed consent (or by parents for paediatric participants); participant covered by social security; participant has no indication of cardiac issues; stable disease (FEV1 > 1000 mL); in the case of insulin‐dependent diabetes, it must be stable; participant had been informed of the results of the medical examination; women of childbearing age confirmed not to be pregnant by urine test. Exclusion criteria: participant with unstable diabetes or known cardiac issues; participant on transplant list. |
Interventions |
Intervention group: partially‐supervised exercise training programme with the aim of exercising 3x per week over 24 months; exercise intensity controlled with heart rate monitors and supported by exercise coaches. Control group: normal daily activities and physiotherapy regimen. |
Outcomes | Included in this study were: VO2 peak; HRQoL (CFQ‐14+ and SF 36). |
Notes | The principal investigator of this study responded on our request and confirmed that the study has been closed prematurely due to local organisational and recruitment problems. No publication is planned for this study. |