在CFTR调节器下治疗囊性纤维化儿童和青少年的强度导向虚拟运动训练干预 (FIQMODE研究):随机对照试验的研究协议
Lisset Pantoja-Arévalo1, Thomas Yvert1, Tamara Iturriaga2
1ImFINE Research Group, Department of Health and Human Performance, Universidad Politécnica de Madrid, Madrid, Spain.
Current protocols
|September 18, 2025
概括
这项研究调查了一个虚拟的炼计划.
科学领域:
- 儿科运动生理学
- 囊性纤维化研究研究
- 康复医学是康复的医学.
背景情况:
- 在接受elexacaftor/tezacaftor/ivacaftor (ETI) 治疗的儿科囊性纤维化 (CF) 患者中,肌肉健康尚未得到研究.
- 与调节器治疗一起优化身体功能对于改善年轻CF患者的长期结果至关重要.
研究的目的:
- 评估受监督的,以力量为导向的虚拟实时运动干预对治疗ETI的儿科CF患者肌肉健康和心肺健康 (CRF) 的影响.
- 评估"FIQMODE"研究的新运动方案的可行性和有效性.
- 提供基于证据的方法,将运动纳入CF管理.
主要方法:
- 一个双臂随机对照试验 (RCT),涉及患有CF的儿童和青少年接受ETI治疗.
- 干预组将参加为期16周的监督,以力量为重点的虚拟实时炼计划.
- 对照组将遵守标准体育活动指南;结果在基线,16周和8个月后续测量.
主要成果:
- 主要结果包括改善下肢和上肢力量,呼吸肌肉力量,功能移动性,人体测量和身体组成.
- 二级结局包括临床病史,肺功能,炎症标志物,生活方式,生活质量 (QoL),坚持和饮食质量.
- 这项研究旨在证明肌肉健康和CRF的显著益处.
结论:
- 该FIQMODE研究将为接受ETI治疗的儿科CF患者建立一个强大的,基于证据的炼方案.
- 这种干预有可能提高肌肉质量,减少肺部恶化,并补充药理疗法.
- 与ETI一起实施标准化的运动疗法旨在改善CF的儿童和青少年的整体生活质量.
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