太极拳对老年人多部位疼痛和跌倒的影响
2026年5月27日 更新者:Tongjian You、University of Massachusetts, Boston
越来越多的证据支持更多的疼痛,无论是通过疼痛部位的数量还是疼痛的严重程度来衡量,都与较差的认知功能和活动能力以及老年人跌倒的风险有关。
太极拳全面整合了身体和认知功能,不仅可以减轻疼痛,还可以改善许多患有慢性多部位疼痛的老年人的注意力和活动能力。
这项拟议的全尺寸随机对照太极拳试验是我们之前研究慢性疼痛、注意力需求、活动能力和老年人跌倒的工作的直接延伸,并建立在研究人员的 NIA 支持的太极拳可行性和可接受性试点研究的基础上在患有多部位疼痛和跌倒风险的老年人中。
这项单盲随机对照试验的目的是研究为期 24 周的太极拳干预对慢性疼痛、认知、活动能力、跌倒恐惧以及患有多部位疼痛和跌倒的风险。
本研究的结果将为确定太极拳在慢性多部位疼痛管理中的临床意义以及探索太极拳改善慢性疼痛症状和降低高危老年人总跌倒率和受伤跌倒率的机制奠定基础。成年人。
研究概览
详细说明
研究人员将在 200 名老年人(太极:N=100 ,和运动控制:N=100)。
研究人员还将测量干预期间和干预后 12 个月内的总跌倒率和受伤跌倒率。
主要目的是: 1. 检查太极拳对患有多部位疼痛的老年人疼痛症状的影响。
据推测,与轻度体育锻炼对照组相比,接受太极拳干预的老年人疼痛减轻(以疼痛严重程度和干扰程度衡量); 2. 研究太极拳对患有多部位疼痛的老年人的跌倒恐惧以及跌倒总数和受伤率的影响。
据推测,在太极拳干预期间和之后的 48 周内,太极拳干预组的老年人在对跌倒的恐惧方面会有更大的改善,并且与轻度运动对照组相比,总跌倒次数和伤害性跌倒次数更少。
次要/探索性目标是: 3. 检查太极拳对患有多部位疼痛的老年人疼痛相关生物标志物的影响。
据推测,与轻度体育锻炼对照组相比,接受太极拳干预的老年人与疼痛相关的生物标志物水平较低; 4. 检验太极拳对慢性疼痛的改善对降低患有多部位疼痛的老年人跌倒率的作用。
据推测,跌倒率的降低取决于患有慢性多部位疼痛的老年人疼痛症状的改善; 5. 研究太极拳在降低患有多部位疼痛的老年人跌倒率方面的认知和活动能力改善的作用。
据推测,慢性疼痛和跌倒率的降低是由患有慢性多部位疼痛的老年人的认知和活动能力的变化所介导的。
研究类型
介入性
注册 (估计的)
266
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
不
描述
纳入标准:
- 65岁及以上
- 有慢性多部位(2 个或更多部位)肌肉骨骼疼痛(在前一年持续 3 个月或更长时间,并在前一个月出现)
- 报告前一年至少有 1 次跌倒或目前使用辅助装置行走(拐杖或助行器)
- 能够在没有个人帮助的情况下步行 20 英尺
- 在过去 5 年内从未练习过太极拳或其他身心锻炼
- 能用英语沟通
排除标准:
- 积极从事中度至剧烈运动超过 40 分钟/周
- 在过去一年内练习过太极拳或其他身心锻炼
- 在过去 5 年内练习过太极拳或其他身心锻炼 3 个月或以上
- 医生对可能影响参与研究的任何疾病的诊断,包括:不稳定的心脏病、中风、类风湿性关节炎、退行性神经肌肉疾病、帕金森病、绝症或痴呆症
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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 |
|---|---|
|
安慰剂比较:轻度体育锻炼
正常配速步行、力量练习、伸展运动、平衡练习。
|
One hour each session, two sessions each week, for 6 months.
Each session will be structured into three 15-minute segments (including warm-up activities/balance exercise/walking, upper and lower body strength exercise/walking, and stretching exercise/balance exercise/walking, respectively), each ending with a short break to record the Borg Rating of Perceived Exertion (RPE), followed by a 5-minute break time or cool-down/wrap-up session.
The session will be taught by a certified exercise physiologist and a research assistant.
|
|
有源比较器:太极
太极走练和杨式太极八式。
|
One hour each session, two sessions each week, for 6 months.
Each session will be structured into three 15-minute segments (including warm-up activities/balance exercise/breathing exercise, Tai Chi walking drills, and Tai Chi 8-form, respectively), each ending with a short break to record the RPE, and followed by a 5-minute break or cool-down/wrap-up session.
The session will be taught by an experienced Tai Chi instructor and a research assistant.
|
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 |
|---|---|---|
|
Pain severity
大体时间:6 months
|
Pain severity will be assessed using the Brief Pain Inventory.
|
6 months
|
|
Pain interference
大体时间:6 months
|
Pain interference will be assessed using the Brief Pain Inventory.
|
6 months
|
|
Fear of falling
大体时间:6 months
|
Fear of falling will be assessed using the Tinetti Falls Efficacy Scale.
|
6 months
|
|
Rate of falls
大体时间:12 months
|
Rate of falls will be assessed using monthly falls calendar postcards.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
C-reactive protein
大体时间:6 months
|
Plasma levels of C-reactive protein will be measured using enzyme-linked immunosorbent assays.
|
6 months
|
|
Interleukin 6
大体时间:6 months
|
Plasma levels of interleukin 6 will be measured using enzyme-linked immunosorbent assays.
|
6 months
|
|
Tumor necrosis factor alpha
大体时间:6 months
|
Plasma levels of tumor necrosis factor alpha will be measured using enzyme-linked immunosorbent assays.
|
6 months
|
|
Nuclear factor kappa B
大体时间:6 months
|
Plasma levels of nuclear factor kappa B will be measured using enzyme-linked immunosorbent assays.
|
6 months
|
|
Beta endorphin
大体时间:6 months
|
Plasma levels of beta endorphin will be measured using an enzyme-linked immunosorbent assay.
|
6 months
|
|
Attention
大体时间:6 months
|
Attention will be assessed by using 4 subscales of the Test of Everyday Attention.
|
6 months
|
|
Executive function
大体时间:6 months
|
Executive function will be assessed using the Trailmaking test, which requires the connection of sequentially numbered circles (part A), and the connection of circles marked by numbers and letters in alternating sequence (part B).
|
6 months
|
|
Single-task stride time
大体时间:6 months
|
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat.
The mat measures location and timing of individual steps, which then can be used to calculate stride time.
|
6 months
|
|
Single-task stride length
大体时间:6 months
|
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat.
The mat measures location and timing of individual steps, which then can be used to calculate stride length.
|
6 months
|
|
Single-task swing time
大体时间:6 months
|
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat.
The mat measures location and timing of individual steps, which then can be used to calculate swing time.
|
6 months
|
|
Dual-task stride time
大体时间:6 months
|
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat.
During the dual-task walking, the participants will perform 2 sets of cognitive challenges in random order: serial subtractions 3 and 5 from 100.
The mat measures location and timing of individual steps, which then can be used to calculate stride time.
|
6 months
|
|
Dual-task stride length
大体时间:6 months
|
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat.
During the dual-task walking, the participants will perform 2 sets of cognitive challenges in random order: serial subtractions 3 and 5 from 100.
The mat measures location and timing of individual steps, which then can be used to calculate stride length.
|
6 months
|
|
Dual-task swing time
大体时间:6 months
|
Gait will be assessed using a sensored gait mat that has embedded pressure sensors distributed throughout the mat.
During the dual-task walking, the participants will perform 2 sets of cognitive challenges in random order: serial subtractions 3 and 5 from 100.
The mat measures location and timing of individual steps, which then can be used to calculate swing time.
|
6 months
|
|
Free-living physical activity
大体时间:6 months
|
Participants will be instructed to wear an accelerometer (GT3X+, ActiGraph, LLC) on their non-dominant wrist for 7 days.
The manufacturer's software, ActiLife, will be used to process data.
Physical activity counts (per minute per day over the 7 days) will be used as a measure of total physical activity.
|
6 months
|
|
Sleep time
大体时间:6 months
|
Participants will be instructed to wear an accelerometer (GT3X+, ActiGraph, LLC) on their non-dominant wrist for 7 days.
The manufacturer's software, ActiLife, will be used to process data to calculate total daily sleep time.
|
6 months
|
|
Sleep efficiency
大体时间:6 months
|
Participants will be instructed to wear an accelerometer (GT3X+, ActiGraph, LLC) on their non-dominant wrist for 7 days.
The manufacturer's software, ActiLife, will be used to process data to calculate percent sleep during in-bed intervals (sleep efficiency).
|
6 months
|
|
Physical Function
大体时间:6 months
|
Physical function will be measured by the well-validated Short Physical Performance Battery (SPPB), a composite measure of mobility including standing balance, usual-paced 4-meter walk, and time needed for 5 repeated chair stands performed without using arms.
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2030年4月30日
研究完成 (估计的)
2030年7月31日
研究注册日期
首次提交
2018年5月23日
首先提交符合 QC 标准的
2018年10月10日
首次发布 (实际的)
2018年10月15日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月27日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Light physical exercise的临床试验
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
-
Medical College of Wisconsin终止
-
D'Or Institute for Research and EducationTERGOS PESQUISA E ENSINO S.A尚未招聘