患有慢性肌肉骨骼疼痛(飞行员)的脆弱老年人的双重任务训练
抗药性认知双重任务训练对贫穷社区居住的老年人患有慢性肌肉骨骼疼痛的脆弱状态和认知功能的影响:飞行员随机对照试验
这项临床试验的目的是调查一个为期12周的双任务培训计划对社区贫困和慢性肌肉骨骼疼痛的社区老年人的脆弱状态的影响。
主要问题:一项为期12周的双任务培训计划的影响是什么,该计划将抵抗力和认知培训结合在一起,对社区居住的老年人的脆弱状态结合在一起,他们患有脆弱和慢性肌肉骨骼疼痛?
参与者将参加有监督的培训课程(双任务培训[干预小组]或伸展运动[对照组])12周。
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hong Kong、香港
- PolyU Institutional Review Board, The Hong Kong Polytechnic University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
- 成年人,年龄60岁或更高,居住在香港,能够使用蒂尔堡(Tilburg)脆弱指标(TFI)(TFI)(总分≥5)(问题9)进行筛查,筛查,脆弱(问题9)(Gobbens等人,2010年)(2010年),经历痛苦的次数更高或痛苦的量表,该量表越来越高于痛苦的量表,该量表越过了4个级别的量表。招募。
排除标准:
- 以下任何一个人都将被排除:下肢或椎骨中没有脆弱的手术程序;轮椅绑定或无法步行五分钟;严重的平衡障碍;未补偿的心脏或血管状况;急性炎症性肌肉骨骼条件;持续的癌症;失智;神经系统疾病,例如中风,帕金森氏病,小脑病,骨髓病和周围神经病;精神疾病,例如精神分裂症,躁郁症,精神病,边缘性人格障碍;文盲。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:干预小组 - 双任务培训计划
干预小组的参与者将参与一项双重任务培训计划,其中阻力培训将与认知任务合并(每周2个会议,共连续10周)。
培训课程将在研究小组成员的指导和监督下在学术机构中进行。
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干预小组的参与者将参与一项双重任务培训计划,其中阻力培训将与认知任务合并。 - 阻力训练:将指示参与者以适当的形式进行以下练习:(1)蹲在椅子上,(2)坐着的单侧髋部弯曲,(3)坐着的单侧膝盖伸展,(4)站立的单侧膝盖屈曲和(5)双侧小腿升高。 下肢练习将进行四个上肢练习:(6)坐着的肘部弯曲,(7)扭动毛巾,(8)手臂和肘部的水平开口,(9)手臂和肘部的对角线开口。 - 认知任务:将要求受试者通过阻力训练练习同时执行口头流利的任务或精神算术任务。 |
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有源比较器:对照组 - 抵抗运动
对照组中的受试者将仅执行阻力练习(每周2个会话,共连续10周),而无需接受任何认知训练。
培训课程将在我们研究团队成员的指导和监督下在学术机构中进行。
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对照组中的受试者只会在不接受任何认知训练的情况下进行阻力练习。
十分钟的热身和冷静的课程将在每个练习之前进行。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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脆弱状态
大体时间:基线(第0周)和治疗后(第10周)
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由Tilburg脆弱指标(TFI)衡量。
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基线(第0周)和治疗后(第10周)
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脆弱状态
大体时间:基线(第0周)和治疗后(第10周)
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通过油炸脆弱表型(FFP)测量。
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基线(第0周)和治疗后(第10周)
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脆弱状态
大体时间:基线(第0周)和治疗后(第10周)
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通过短体性能电池(SPPB)来衡量。
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基线(第0周)和治疗后(第10周)
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可行性与可接受性
大体时间:治疗后(第10周)
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主要结局指标将是双任务训练计划的可行性和可接受性。
可行性将通过该计划的招募率和依从率进行评估。
招募率将定义为招募的参与者总数占筛查参与者总数的比例。
治疗依从性将定义为每组参与者参加预定训练课程的比例。
可接受性将通过基于参与体育活动障碍的六项后计划问卷进行评估。
问卷将询问参与者对计划重要性和满意度的感知、训练期间感到的任何不适、练习难度、时长适宜性以及对日常活动的有用性,并要求参与者根据从“非常不同意”到“非常同意”的五点李克特量表进行评分,这些数据将在干预结束时收集。
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治疗后(第10周)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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认知功能
大体时间:基线(第0周)和治疗后(第10周)
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通过香港版本蒙特利尔认知评估(HK-MOCA)衡量。
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基线(第0周)和治疗后(第10周)
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认知功能
大体时间:基线(第0周)和治疗后(第10周)
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通过正向数字跨度测试测量。
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基线(第0周)和治疗后(第10周)
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认知功能
大体时间:基线(第0周)和治疗后(第10周)
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通过认知失败问卷(CFQ)(中文版)来衡量,这是一种自我报告措施,以评估日常生活中个人健忘,分散性和虚假触发的自我报告措施。 - 它有25个项目(0-4分)。 总分范围从0到100分。 较高的观点表明日常生活中的认知困难较少。 |
基线(第0周)和治疗后(第10周)
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疼痛水平
大体时间:基线(第0周)和治疗后(第10周)
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平均疼痛评分将通过数值疼痛评分量表(NPRS)评估。
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基线(第0周)和治疗后(第10周)
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与健康相关的生活质量
大体时间:基线(第0周)和治疗后(第10周)
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由Euroqol 5维度5级(EQ-5D-5L)(香港中文版)问卷测量。
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基线(第0周)和治疗后(第10周)
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合作者和调查者
调查人员
- 首席研究员:Derek Yau、The Hong Kong Polytechnic University
出版物和有用的链接
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研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- HSEARS20250310005
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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