DRKS00033030招募中未知
Move-PCD – A multi-center longitudinal randomized controlled trial on the effect of a 6-month individualized and supervised physical activity (PA) program on quality of life (QoL) in children, adolescents, and adults with primary ciliary dyskinesia - Move-PCD
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 159
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 7 Years 至 55 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •Disability to take part in a PA program due to medical or other reasons
- •oDecompensated heart failure
- •oCor pulmonale
- •oArterial hypertension that is not normal under medical therapy
- •oMyocarditis in the last 6 months
- •oUnstable/progressive angina pectoris (e.g., new onset of angina, increase in symptoms, more need for medication)
- •oUncontrolled arrhythmias (e.g., recurrent ventricular tachycardia, tachyarrhythmias, atrial fibrillation)
- •oMedium- to high-grade cardiac vitals, especially of the left heart (high-grade or symptomatic aortic valve stenosis, high-grade mitral valve insufficiency)
- •oHeart attack in the last 3 months incl. PTCA (percutaneous coronary intervention)
- •oHeart operations (incl. pacemaker/ICD operation in the last 3 months)
- •oApoplexy in the last 5 years
- •oUncontrolled bronchial asthma (i.e., on-demand medication more than 2 days a week or nocturnal symptoms).
- •oLung transplantation (also planned)
- •oRespiratory partial insufficiency with intermittent or continuous oxygen therapy
- •oContinuous NIV (non-invasive ventilation)
- •oHaemato-oncological diseases currently under therapy
- •oPhysical inability to participate in PA or orthopaedic limitations that preclude participation in the motor test battery
- •oAny 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.
- •oAlcohol or drug abuse
- •oPregnancy (during the study drop-out criterion)
- •oPhysical 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
研究者
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