通过身心锻炼照顾看护者
研究概览
详细说明
看护者 (CG) 经常会经历严重的心理和身体痛苦,导致看护者的健康和生活质量 (QOL) 显着下降。 减少 CG 痛苦有可能改善 CG 的身心健康,提高整体 QOL,并改善他们提供的护理。
然而,很少有可以广泛实施和容易坚持的有效干预措施得到严格评估。 气功是一种越来越受欢迎的多模式身心锻炼,它有望解决与 CG 高度相关的广泛的社会心理和身体因素。 气功与太极拳有许多相同的特点,它融合了缓慢而温和的运动、呼吸训练和多种认知技能的元素,包括提高身体意识、集中精神注意力和意象——与单模式疗法相比,这些共同可以为健康带来更大的好处。 强大的证据基础支持气功和太极拳的团体训练可以改善不同人群的身心健康、生活质量和自我效能的多个领域。 值得注意的是,最近的全国调查表明,报告使用气功和太极进行健康锻炼的美国人口中有很大一部分更喜欢通过 DVD 和互联网资源进行自主学习。 虽然少数研究支持基于网络或基于 DVD 的身心实践学习的潜力,但对此类程序的评估尚未经过充分测试,尤其是在 CG 中。
使用癌症护理人员 (CCG) 作为更大的 CG 人群的代表人群,长期目标是进行一项确定性试验,评估广泛使用且先前研究过的气功养生法(八段锦、八段锦气功)。 干预措施将在由教师领导的社区小组中提供,或通过互联网向个人提供,这些个人通过录制的指导性指导进行学习,并辅以来自教师的间歇性虚拟实时反馈。 结果将包括生活质量、疲劳、睡眠障碍、心理困扰、照顾者负担和身体机能。 此 R34 的短期目标是进行混合方法试点随机对照试验 (RCT),以告知最终试验的可行性和设计。 研究人员将通过将 54 个 CCG 随机分配 (1:1:1) 到以下三种情况之一来实现这些目标:(1) 以社区为基础的气功计划; (二)网络气功项目; (3) 自理对照组。
具体目标 1 是最终确定气功干预内容和传递协议。 具体目标 2 将评估气功在基于社区的小组课程中的“可学习性”,并通过基于网络的协议使用一种新颖的熟练程度工具进行评估。 具体目标 3 将评估招募和保留 CCG 进入为期 12 周的临床试验并完成所有结果测试方案的可行性。 研究的可行性和优点将通过对研究完成者、退出的参与者和气功教练的退出面谈的正式定性分析进一步了解。
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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Texas
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Houston、Texas、美国、77004
- University of Houston
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:
- 参与者是为癌症患者提供身体、情感和/或经济支持的配偶、伴侣、家庭成员或朋友。
- 参与者能够理解、说和阅读英语。
- 参与者在适用于护理人员的国家综合癌症网络 (NCCN) 痛苦温度计上的最低级别为 3。
- 参与者能够提供知情同意。
排除标准:
- 参与者没有不稳定的疾病(例如,最近住院、不稳定的心血管疾病、活动性癌症)。
- 参与者没有精神疾病(例如,无法控制的抑郁症或精神病、药物滥用、严重的人格障碍)
- 参与者没有退行性神经肌肉疾病(例如,帕金森病、多发性硬化症)。
- 参与者不能连续行走 15 分钟。
- 参与者最近没有参加常规气功或类似(例如,瑜伽或太极)课程的历史,这些课程定义为过去 6 个月内 20 节或更多课程。
- 参与目前每周不从事超过240分钟的中等强度运动。
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:平行线
- 屏蔽:没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:社区气功组
随机分配到该组的参与者每周上一节 75 分钟的课,并在另外 3 天进行 20 分钟的家庭练习。
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以社区为基础的气功小组将每周参加一节 75 分钟的气功课,为期 12 周。
此外,参与者每周在家练习气功 3 天,每天 20 分钟。
将提供印刷材料以指导家庭练习。
其他名称:
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实验性的:互联网气功组
随机分配到该组的参与者参加两次在线课程,每次 40 分钟,另外 3 天还辅以 20 分钟的家庭练习。
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互联网指导气功组将获得一台平板电脑,用于在线气功课程。
研究协调员将向分配到该组的所有参与者提供使用气功程序的教程。
参与者将被要求每周两次参加 40 分钟长的气功课程,持续 12 周,并每周 3 天每天额外练习 20 分钟。
所有课程都将在家中完成。
其他名称:
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NO_INTERVENTION:自理对照组
自理对照组将被要求在研究期间不要练习任何气功。
将向参与者提供一本关于护理的教育书籍,其中包括与护理和护理人员健康相关的自导活动(护理人员帮助手册:护理的强大工具)。
本书基于证据的计划旨在为护理人员提供工具,以增强他们的自我保健能力和处理困难情况、情绪和决定的信心。
此外,研究人员将每月给自理对照组的参与者打电话一次。
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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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招募参与者的资格
大体时间:6个月
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资格由愿意同意参加研究的合格参与者的百分比评估。
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6个月
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坚持干预
大体时间:6个月
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通过对课程和家庭实践的遵守率评估干预依从性。
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6个月
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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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流行病学研究中心抑郁量表修订版 (CESD-R-10)
大体时间:6个月
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由 10 个项目组成的抑郁症自我报告测量。
总分是根据10个项目的总和计算的。
每个项目的得分为 0 到 3,总分在 0 到 30 之间。
任何等于或大于 10 的分数都被认为是抑郁的。
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6个月
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简要疲劳清单 (BFI)
大体时间:6个月
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疲劳的自我报告测量由 9 个项目组成,测量疲劳的严重程度以及疲劳对过去 24 小时日常功能的影响。
每项评分为 0-10,其中 0 表示没有疲劳,10 表示极度疲劳,总分介于 0 和 90 之间。
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6个月
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匹兹堡睡眠质量指数 (PSQI),睡眠障碍
大体时间:6个月
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睡眠障碍自我报告测量由 19 个项目组成,测量患者过去一个月的睡眠质量、睡眠潜伏期、睡眠持续时间、习惯性睡眠效率、睡眠障碍、睡眠药物使用和日间功能障碍。
得出七个组成部分的分数,每个分数从 0(无难度)到 3(严重困难)。
将组件分数相加以产生全局分数(范围 0 到 21)。
分数越高表明睡眠质量越差。
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6个月
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看护者负担量表 (CBS)
大体时间:6个月
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照顾者负担的自我报告测量由 22 个项目组成,测量照顾者对负担三个维度的影响:客观、主观需求和主观压力。
每个项目的得分为 0-4(0=从不;4=几乎总是),总分在 0 到 88 之间。
较高的分数代表较差的结果。
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6个月
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Godin 休闲时间锻炼问卷,体力活动
大体时间:6个月
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自我报告的运动量度由 4 个项目组成,测量轻度、中等强度和高强度休闲体育活动的频率。
每个项目都使用剧烈运动、适度运动和轻度运动的单位进行评分。
更高的单位代表更好的结果。
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6个月
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自我效能感量表,锻炼自我效能感
大体时间:6个月
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自我效能感的自我报告测量由 9 个项目组成,这些项目测量与面对锻炼障碍时继续锻炼的能力相关的自我效能感期望。
每个项目的得分为 0-10(0 = 不自信;10 = 非常自信),总分在 0 到 90 之间。
更高的值代表更好的结果。
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6个月
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认知功能,测试 1
大体时间:6个月
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数字跨度。
参与者将被要求以特定顺序重复数字。
性能由正确记住的平均数字数表示。
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6个月
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认知功能,测试 2
大体时间:6个月
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Trail Making 测试 A 部分和 B 部分。参与者在不从纸上拿起钢笔或铅笔的情况下连接 25 个圆圈时进行计时。
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6个月
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身体机能,测试 1
大体时间:6个月
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握力:惯用手的力量将使用 Jamar 液压手测力计(Patterson Medical - 加拿大,Mississauga,ON,CAN)测量。
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6个月
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身体机能,测试 2
大体时间:6个月
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从坐到站。
参与者将被要求坐在椅子上,双臂交叉在胸前,并在没有手臂帮助的情况下站立。
将记录在 30 秒内完成的次数。
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6个月
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身体机能,测试 3
大体时间:6个月
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平衡。
参与者将进行两次静态单腿姿势控制平衡测试,一次睁眼,一次闭眼。
两者的最长时间将限制为 30 秒。
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6个月
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合作者和调查者
调查人员
- 首席研究员:Pinky Budhrani-Shani, PhD, MSN, RN、University of Houston
- 首席研究员:Peter Wayne, PhD、Brigham and Women's Hospital and Harvard Medical School
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- Ho RTH, Wan AHY, Chan JSM, Ng SM, Chung KF, Chan CLW. Study protocol on comparative effectiveness of mindfulness meditation and qigong on psychophysiological outcomes for patients with colorectal cancer: a randomized controlled trial. BMC Complement Altern Med. 2017 Aug 8;17(1):390. doi: 10.1186/s12906-017-1898-6.
- Xiao CM, Zhuang YC. Effect of health Baduanjin Qigong for mild to moderate Parkinson's disease. Geriatr Gerontol Int. 2016 Aug;16(8):911-9. doi: 10.1111/ggi.12571. Epub 2015 Aug 26.
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- Katrancha ED, Hoffman LA, Zullo TG, Tuite PK, Garand L. Effects of a video guided T'ai Chi group intervention on center of balance and falls efficacy: a pilot study. Geriatr Nurs. 2015 Jan-Feb;36(1):9-14. doi: 10.1016/j.gerinurse.2014.08.015.
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- Sannes TS, Mansky PJ, Chesney MA. The need for attention to dose in mind-body interventions: lessons from t'ai chi clinical trials. J Altern Complement Med. 2008 Jul;14(6):645-53. doi: 10.1089/acm.2007.0680.
- Wayne PM, Kaptchuk TJ. Challenges inherent to t'ai chi research: part I--t'ai chi as a complex multicomponent intervention. J Altern Complement Med. 2008 Jan-Feb;14(1):95-102. doi: 10.1089/acm.2007.7170a.
- Wayne PM, Kaptchuk TJ. Challenges inherent to t'ai chi research: part II-defining the intervention and optimal study design. J Altern Complement Med. 2008 Mar;14(2):191-7. doi: 10.1089/acm.2007.7170b.
- Moy ML, Wayne PM, Litrownik D, Beach D, Klings ES, Davis RB, Yeh GY. Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi. Contemp Clin Trials. 2015 Nov;45(Pt B):458-467. doi: 10.1016/j.cct.2015.09.004. Epub 2015 Sep 8.
- Salmoirago-Blotcher E, Wayne P, Bock BC, Dunsiger S, Wu WC, Stabile L, Yeh G. Design and methods of the Gentle Cardiac Rehabilitation Study--A behavioral study of tai chi exercise for patients not attending cardiac rehabilitation. Contemp Clin Trials. 2015 Jul;43:243-51. doi: 10.1016/j.cct.2015.06.020. Epub 2015 Jun 24.
- Salmoirago-Blotcher E, Wayne PM, Dunsiger S, Krol J, Breault C, Bock BC, Wu WC, Yeh GY. Tai Chi Is a Promising Exercise Option for Patients With Coronary Heart Disease Declining Cardiac Rehabilitation. J Am Heart Assoc. 2017 Oct 11;6(10):e006603. doi: 10.1161/JAHA.117.006603.
- Wayne PM, Gow BJ, Costa MD, Peng CK, Lipsitz LA, Hausdorff JM, Davis RB, Walsh JN, Lough M, Novak V, Yeh GY, Ahn AC, Macklin EA, Manor B. Complexity-Based Measures Inform Effects of Tai Chi Training on Standing Postural Control: Cross-Sectional and Randomized Trial Studies. PLoS One. 2014 Dec 10;9(12):e114731. doi: 10.1371/journal.pone.0114731. eCollection 2014.
- Yeh GY, Chan CW, Wayne PM, Conboy L. The Impact of Tai Chi Exercise on Self-Efficacy, Social Support, and Empowerment in Heart Failure: Insights from a Qualitative Sub-Study from a Randomized Controlled Trial. PLoS One. 2016 May 13;11(5):e0154678. doi: 10.1371/journal.pone.0154678. eCollection 2016.
- Yeh GY, Mu L, Davis RB, Wayne PM. Correlates of Exercise Self-efficacy in a Randomized Trial of Mind-Body Exercise in Patients With Chronic Heart Failure. J Cardiopulm Rehabil Prev. 2016 May-Jun;36(3):186-94. doi: 10.1097/HCR.0000000000000170.
- Yeh GY, Wayne PM, Litrownik D, Roberts DH, Davis RB, Moy ML. Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial. Trials. 2014 Aug 28;15:337. doi: 10.1186/1745-6215-15-337.
- Yeung AS, Feng R, Kim DJH, Wayne PM, Yeh GY, Baer L, Lee OE, Denninger JW, Benson H, Fricchione GL, Alpert J, Fava M. A Pilot, Randomized Controlled Study of Tai Chi With Passive and Active Controls in the Treatment of Depressed Chinese Americans. J Clin Psychiatry. 2017 May;78(5):e522-e528. doi: 10.4088/JCP.16m10772.
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- Budhrani PH, Lengacher CA, Kip KE, Tofthagen C, Jim H. Minority Breast Cancer Survivors: The Association between Race/Ethnicity, Objective Sleep Disturbances, and Physical and Psychological Symptoms. Nurs Res Pract. 2014;2014:858403. doi: 10.1155/2014/858403. Epub 2014 Jul 2.
- Lengacher CA, Johnson-Mallard V, Barta M, Fitzgerald S, Moscoso MS, Post-White J, Jacobsen PB, Molinari Shelton M, Le N, Budhrani P, Goodman M, Kip KE. Feasibility of a mindfulness-based stress reduction program for early-stage breast cancer survivors. J Holist Nurs. 2011 Jun;29(2):107-17. doi: 10.1177/0898010110385938. Epub 2010 Nov 1.
- Lengacher CA, Reich RR, Kip KE, Barta M, Ramesar S, Paterson CL, Moscoso MS, Carranza I, Budhrani PH, Kim SJ, Park HY, Jacobsen PB, Schell MJ, Jim HS, Post-White J, Farias JR, Park JY. Influence of mindfulness-based stress reduction (MBSR) on telomerase activity in women with breast cancer (BC). Biol Res Nurs. 2014 Oct;16(4):438-47. doi: 10.1177/1099800413519495. Epub 2014 Jan 30.
- Lengacher CA, Reich RR, Paterson CL, Jim HS, Ramesar S, Alinat CB, Budhrani PH, Farias JR, Shelton MM, Moscoso MS, Park JY, Kip KE. The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial. Psychooncology. 2015 Apr;24(4):424-32. doi: 10.1002/pon.3603. Epub 2014 Jun 18.
- Lengacher CA, Reich RR, Post-White J, Moscoso M, Shelton MM, Barta M, Le N, Budhrani P. Mindfulness based stress reduction in post-treatment breast cancer patients: an examination of symptoms and symptom clusters. J Behav Med. 2012 Feb;35(1):86-94. doi: 10.1007/s10865-011-9346-4. Epub 2011 Apr 20.
- Lengacher CA, Shelton MM, Reich RR, Barta MK, Johnson-Mallard V, Moscoso MS, Paterson C, Ramesar S, Budhrani P, Carranza I, Lucas J, Jacobsen PB, Goodman MJ, Kip KE. Mindfulness based stress reduction (MBSR(BC)) in breast cancer: evaluating fear of recurrence (FOR) as a mediator of psychological and physical symptoms in a randomized control trial (RCT). J Behav Med. 2014 Apr;37(2):185-95. doi: 10.1007/s10865-012-9473-6. Epub 2012 Nov 27.
- McQuade JL, Prinsloo S, Chang DZ, Spelman A, Wei Q, Basen-Engquist K, Harrison C, Zhang Z, Kuban D, Lee A, Cohen L. Qigong/tai chi for sleep and fatigue in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. Psychooncology. 2017 Nov;26(11):1936-1943. doi: 10.1002/pon.4256. Epub 2016 Sep 20.
- Yeh GY, Wood MJ, Lorell BH, Stevenson LW, Eisenberg DM, Wayne PM, Goldberger AL, Davis RB, Phillips RS. Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial. Am J Med. 2004 Oct 15;117(8):541-8. doi: 10.1016/j.amjmed.2004.04.016.
- Yeh GY, McCarthy EP, Wayne PM, Stevenson LW, Wood MJ, Forman D, Davis RB, Phillips RS. Tai chi exercise in patients with chronic heart failure: a randomized clinical trial. Arch Intern Med. 2011 Apr 25;171(8):750-7. doi: 10.1001/archinternmed.2011.150.
- Yeh GY, Wood MJ, Wayne PM, Quilty MT, Stevenson LW, Davis RB, Phillips RS, Forman DE. Tai chi in patients with heart failure with preserved ejection fraction. Congest Heart Fail. 2013 Mar-Apr;19(2):77-84. doi: 10.1111/chf.12005. Epub 2012 Oct 12.
- Li L, Manor B. Long term Tai Chi exercise improves physical performance among people with peripheral neuropathy. Am J Chin Med. 2010;38(3):449-59. doi: 10.1142/S0192415X1000797X.
- Manor B, Lipsitz LA, Wayne PM, Peng CK, Li L. Complexity-based measures inform Tai Chi's impact on standing postural control in older adults with peripheral neuropathy. BMC Complement Altern Med. 2013 Apr 16;13:87. doi: 10.1186/1472-6882-13-87.
- McGibbon CA, Krebs DE, Wolf SL, Wayne PM, Scarborough DM, Parker SW. Tai Chi and vestibular rehabilitation effects on gaze and whole-body stability. J Vestib Res. 2004;14(6):467-78.
- McGibbon CA, Krebs DE, Parker SW, Scarborough DM, Wayne PM, Wolf SL. Tai Chi and vestibular rehabilitation improve vestibulopathic gait via different neuromuscular mechanisms: preliminary report. BMC Neurol. 2005 Feb 18;5(1):3. doi: 10.1186/1471-2377-5-3.
- Wayne PM, Manor B, Novak V, Costa MD, Hausdorff JM, Goldberger AL, Ahn AC, Yeh GY, Peng CK, Lough M, Davis RB, Quilty MT, Lipsitz LA. A systems biology approach to studying Tai Chi, physiological complexity and healthy aging: design and rationale of a pragmatic randomized controlled trial. Contemp Clin Trials. 2013 Jan;34(1):21-34. doi: 10.1016/j.cct.2012.09.006. Epub 2012 Sep 29.
- Wayne PM, Kiel DP, Buring JE, Connors EM, Bonato P, Yeh GY, Cohen CJ, Mancinelli C, Davis RB. Impact of Tai Chi exercise on multiple fracture-related risk factors in post-menopausal osteopenic women: a pilot pragmatic, randomized trial. BMC Complement Altern Med. 2012 Jan 30;12:7. doi: 10.1186/1472-6882-12-7.
- Yeung A, Lepoutre V, Wayne P, Yeh G, Slipp LE, Fava M, Denninger JW, Benson H, Fricchione GL. Tai chi treatment for depression in Chinese Americans: a pilot study. Am J Phys Med Rehabil. 2012 Oct;91(10):863-70. doi: 10.1097/PHM.0b013e31825f1a67.
- Wayne PM, Gagnon MM, Macklin EA, Travison TG, Manor B, Lachman M, Thomas CP, Lipsitz LA. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing. Contemp Clin Trials. 2017 Sep;60:96-104. doi: 10.1016/j.cct.2017.07.005. Epub 2017 Jul 8.
- Carlson LE, Zelinski EL, Speca M, Balneaves LG, Jones JM, Santa Mina D, Wayne PM, Campbell TS, Giese-Davis J, Faris P, Zwicker J, Patel K, Beattie TL, Cole S, Toivonen K, Nation J, Peng P, Thong B, Wong R, Vohra S. Protocol for the MATCH study (Mindfulness and Tai Chi for cancer health): A preference-based multi-site randomized comparative effectiveness trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) for cancer survivors. Contemp Clin Trials. 2017 Aug;59:64-76. doi: 10.1016/j.cct.2017.05.015. Epub 2017 May 30.
- Lengacher CA, Kip KE, Barta M, Post-White J, Jacobsen PB, Groer M, Lehman B, Moscoso MS, Kadel R, Le N, Loftus L, Stevens CA, Malafa MP, Shelton MM. A pilot study evaluating the effect of mindfulness-based stress reduction on psychological status, physical status, salivary cortisol, and interleukin-6 among advanced-stage cancer patients and their caregivers. J Holist Nurs. 2012 Sep;30(3):170-85. doi: 10.1177/0898010111435949. Epub 2012 Mar 21.
- Reich RR, Lengacher CA, Alinat CB, Kip KE, Paterson C, Ramesar S, Han HS, Ismail-Khan R, Johnson-Mallard V, Moscoso M, Budhrani-Shani P, Shivers S, Cox CE, Goodman M, Park J. Mindfulness-Based Stress Reduction in Post-treatment Breast Cancer Patients: Immediate and Sustained Effects Across Multiple Symptom Clusters. J Pain Symptom Manage. 2017 Jan;53(1):85-95. doi: 10.1016/j.jpainsymman.2016.08.005. Epub 2016 Oct 5.
- Rosengren KS, Christou E, Yang Y, Kass D, Boule A. Quantification of taiji learning in older adults. J Am Geriatr Soc. 2003 Aug;51(8):1186-7. doi: 10.1046/j.1532-5415.2003.51376.x. No abstract available.
- Fischer M, Fugate-Woods N, Wayne PM. Use of pragmatic community-based interventions to enhance recruitment and adherence in a randomized trial of Tai Chi for women with osteopenia: insights from a qualitative substudy. Menopause. 2014 Nov;21(11):1181-9. doi: 10.1097/GME.0000000000000257.
- Yeh GY, Roberts DH, Wayne PM, Davis RB, Quilty MT, Phillips RS. Tai chi exercise for patients with chronic obstructive pulmonary disease: a pilot study. Respir Care. 2010 Nov;55(11):1475-82.
- Budhrani-Shani P, Chau NG, Berry DL. Psychosocial distress and the preferred method of delivery of mind-body interventions among patients with head-and-neck cancer. Patient Relat Outcome Meas. 2018 Apr 3;9:129-136. doi: 10.2147/PROM.S149978. eCollection 2018.
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生活质量的临床试验
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