Q34
Conditions
Interventions
Group 1: In addition to standard PCD treatment, the intervention group will receive an individualized PA program for 6 months which takes personal preferences into account and includes regular online
Sponsors
Ruhr-Universität Bochum
Eligibility
Sex/Gender
All
Age
7 Years to 55 Years
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of Primary Ciliary Dyskinesia according to ERS criteria (PCD confirmed or highly likely), signed and dated informed consent form of the participants and of the guardian (in case of minors), willingness to participate in the activity program and weekly phone contacts and to wear the activity tracker for one year
Exclusion criteria
Exclusion criteria: Disability to take part in a PA program due to medical or other reasons o Decompensated heart failure o Cor pulmonale o Arterial hypertension that is not normal under medical therapy o Myocarditis in the last 6 months o Unstable/progressive angina pectoris (e.g., new onset of angina, increase in symptoms, more need for medication) o Uncontrolled arrhythmias (e.g., recurrent ventricular tachycardia, tachyarrhythmias, atrial fibrillation) o Medium- to high-grade cardiac vitals, especially of the left heart (high-grade or symptomatic aortic valve stenosis, high-grade mitral valve insufficiency) o Heart attack in the last 3 months incl. PTCA (percutaneous coronary intervention) o Heart operations (incl. pacemaker/ICD operation in the last 3 months) o Apoplexy in the last 5 years o Uncontrolled bronchial asthma (i.e., on-demand medication more than 2 days a week or nocturnal symptoms). o Lung transplantation (also planned) o Respiratory partial insufficiency with intermittent or continuous oxygen therapy o Continuous NIV (non-invasive ventilation) o Haemato-oncological diseases currently under therapy o Physical inability to participate in PA or orthopaedic limitations that preclude participation in the motor test battery o Any condition, fact or comorbidity for which, in the opinion of the study investigator, study participation is not possible to participate, which represent an additional risk for study participation or lead to a falsification of the result. o Alcohol or drug abuse o Pregnancy (during the study drop-out criterion) o Physical complaints on exertion like Dyspnoea beyond the expected level, Syncope or Chest pain/nausea o Examination results leading to exclusion like missing foot pulses, central cyanosis, ST elevation, AV block of grade II or higher, Long-QT, FEV1 < 30%, sO2 < 90% Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| physical functioning domain of QoL-PCD questionnaire 6 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| lung function, number of pulmonary exacerbations and hospitalizations due to the underlying diseases, all other domains of QoL (in addition to primary outcome), PA and fitness (after 6 and 12 months) | — |
Countries
Germany
Contacts
Public ContactFolke Brinkmann
Universitätsklinik für Kinder- und Jugendmedizin am St. Josef Hospital
Outcome results
None listed