cystic fibrosis mucoviscidosis
Conditions
Interventions
A total of 20 patients with CF, of at least 12 years of age, with a FEV1 *35%
predicted will be randomised. Following baseline assessment patients will be
randomized into an intervention and a contr
conditioning program
Cystic Fibrosis
partial supervision
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
12 Years to 64 Years
Inclusion criteria
Inclusion criteria: * CF based on either two CF-causing mutations and/or a sweat chloride concentration during two tests of >60 mmol/l. * Age * 12 years * FEV1 * 35% predicted (based on the equations published by Stanojevic et al. 2008) * Access to the internet
Exclusion criteria
Exclusion criteria: * Participation in another clinical trial up to 4 weeks prior to the first baseline visit * Pregnancy/Breastfeeding * Status post lung transplantation * Inability to exercise * More than 4 hours of reported strenuous physical activities per week currently or up to 3 months prior to baseline measurements and not already planned within the coming 6 months. * Unstable condition affecting pulmonary function or exercise participation (i.e., major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and ivantibiotics during the last 4 weeks, unstable allergic bronchopulmonary aspergillosis, planned surgery, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor) * Cardiac arrhythmias with exercise * Requiring additional oxygen with exercise * Recent diagnosis of diabetes 3 months prior to or at screening * Recent changes in medication 1 month or less prior to screening (systemic steroids, ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline) * At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or planned stop of ivacaftor during the trial * Colonization with Burkholderia cenocepacia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this pilot study is to evaluate the feasibility of the study protocol. The ACTIVATE-CF protocol will be judged feasible when at least 75% of the included patients can comply to the study protocol (with regard to both the intervention and the control group). Moreover, at least 75% of the intervention group has to succeed to increase their physical activity levels, so that they engage in a minimum of 3 hours of at least moderate activity per week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes of this study will be: - Difference between reported quality of life (CFR-Q scores) from baseline to 6 months in the intervention group compared to controls - Difference between the changes in FEV1 (in% predicted) from baseline to 6 months in the intervention group compared to controls. - FVC (% predicted) and RV/TLC (%) - Differences between the changes in reported physical activity (with the HAES questionnaire) from baseline to 6 months in the intervention group compared to controls. - Difference between reported fatigue (CIS-20 and only for the pediatric subjects, PedsQL fatigue scores) from baseline to 6 months in the intervention group compared to controls - Differences between reported levels of stress, anxiety and depression (DASS scores) from baseline to 6 months in the intervention group compared to controls. - Difference between VO2peak (%predicted) from baseline to 6 months in the intervention group compared to the controls - Difference between maximal aerobic power (Wmax, %predicted) from baseline to 6 months in the intervention group compared to the controls We further intend to assess the persistence of behavioral changes and benefits from the intervention once the supervision is largely withdrawn. | — |
Countries
Australia, France, Germany, Netherlands, Switzerland, United Kingdom, United States of America
Outcome results
None listed