Pilot: Feasibility of a partially supervised conditioning program in patients with CF: ACTIVATE- CF.
- Conditions
- 10038686cystic fibrosismucoviscidosis
- Registration Number
- NL-OMON45217
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
* 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
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary aim of this pilot study is to evaluate the feasibility of the study<br /><br>protocol. The ACTIVATE-CF protocol will be judged feasible when at least 75% of<br /><br>the included patients can comply to the study protocol (with regard to both the<br /><br>intervention and the control group).<br /><br>Moreover, at least 75% of the intervention group has to succeed to increase<br /><br>their physical activity levels, so that they engage in a minimum of 3 hours of<br /><br>at least moderate activity per week. </p><br>
- Secondary Outcome Measures
Name Time Method