A Randomized Study of the Effect of Tai Chi Chuan Compared to Exercise
A Randomized Study of the Effect of Tai Chi Chuan Compared to Exercise
批准号:
8336408
负责人:
Robert Nussenblatt
金额:
$1.88万
依托单位:
--
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
AdultAerobicAerobic ExerciseAnnual ReportsAreaAsiansBody fatCancer SurvivorCardiovascular DiseasesCharacteristicsChildhoodCombined Modality TherapyConflict (Psychology)Control GroupsDataDaughterDiagnosisDisabled PersonsEligibility DeterminationEnrollmentEvaluable DiseaseExerciseFamilyFatigueFrequenciesFutureHealedHyperlipidemiaIncidenceInterventionLifeLong-Term SurvivorsMalignant - descriptorMetabolicMetabolic syndromeMusculoskeletalNervous system structureOperative Surgical ProceduresParticipantPatientsPerformancePersonal SatisfactionPopulationPregnancyProcessPsychological StressQuality of lifeRadiation therapyRandomizedRoleScheduleScreening procedureSolid NeoplasmStressSurvivorsTai JiTelephoneTimeWaiting ListsWorkarmbasecancer therapychemotherapycohortconditioningdesignfallsfollow-uphealingimprovedinterestprogramspsychological distresssarcomastressor
中文摘要
癌症的诊断和治疗对任何患者来说都是一生的主要压力源。虽然威胁生命的疾病的诊断是有压力的,但接受癌症治疗(包括手术、放射治疗和化疗)会给患者带来压力。此外,癌症治疗经常与疲劳、身体机能丧失和代谢综合征的代谢异常有关,这导致人们猜测,癌症治疗可能会使幸存者更容易患上代谢综合征及其后遗症-心血管疾病。在最近进行的一项研究中,我们发现在长期存活的儿童肉瘤患者中,高脂血症的发生率高,体脂含量增加,有氧运动能力和肌肉骨骼功能下降,心理痛苦参数出现频率高(1,3)。基于这些数据和发现,似乎有必要设计一项计划,帮助癌症幸存者不仅像体育锻炼计划所提供的那样改善肌肉骨骼功能和有氧运动能力,而且还能缓解心理压力,并在完成多模式治疗后提高癌症幸存者的幸福感。太极拳(TCC)在亚洲文化中已经被使用了几个世纪,以改善健康,减轻压力,并通过改善气血来促进康复。虽然许多研究已经在不同的人群中为这些说法提供了科学支持,但TCC在癌症幸存者管理中的有益作用尚未确立。
自研究开始以来,我们共收到233宗由临市局转介的个案,其中135宗是在过去一年8/31/07年后转介的。在这233名转介个案中,55名(24%)已登记在校就读,13名(6%)现正接受筛选,53名(23%)经电话筛选不符合资格,12名(5%)将於稍后重新评估,以确定是否符合资格,而100名(43%)则不感兴趣、不是好的候选人或失去跟进机会。因此,自上一份年度报告以来,我们又招募了37名在校研究参与者(自去年以来增加了49%)。
在登记在册的55名研究参与者中,其中8人完成了等待名单控制组,并被重新随机分配到一项运动干预中;因此,总共有63名可评估的参与者。在这些人中,36人(57%)完成了12周的研究期,19人(30%)正在进行中(2人正在完成当前的队列,10人参加了2008年秋季的队列,7人要求未来的队列),9人(14%)在开始学习之前或在参与学习期间退出。
在9名退出的参与者中,4人在开始研究前退出(1人因怀孕,2人因家庭/工作安排冲突,1人不想进入对照组),5人在研究期间退出(1人因足底筋膜炎加重,4人因工作时间冲突)。另外三名完成等待名单控制组的参与者选择在重新随机之前退出参与;他们退出的原因包括从该地区搬迁,因残疾女儿而安排冲突,以及不想参加研究的自行车运动。
本研究旨在通过随机、等待名单对照设计,比较TCC和运动方案在提高恶性实体肿瘤成年幸存者有氧运动能力和耐力、减轻压力和改善生活质量方面的疗效。
英文摘要
Diagnosis and treatment for cancer represent a major life-time stressor for any patient. While the diagnosis of a life-threatening illness is stressful, undergoing treatment for cancer including surgery, radiotherapy and chemotherapy result in stress to the patient. In addition, cancer treatment frequently is associated with fatigue, physical de-conditioning and metabolic abnormalities characteristic of the metabolic syndrome, leading to speculations that cancer therapy may render survivors more prone to developing metabolic syndrome and its sequelae, cardiovascular disease. In a recently conducted study we detected a high incidence of hyperlipidemia and increased body fat content, decreased aerobic performance and musculoskeletal functioning and a high frequency of parameters of psychological distress in long-term survivors of pediatric sarcoma (1, 3). Based on these data and findings, it appears desirable to devise a program that would help cancer survivors not only to improve musculoskeletal functioning and aerobic performance, as a physical exercise program would offer, but in addition relieve psychological stress and enhance the well-being of cancer survivors after completion of treatment with multimodality therapy. Tai Chi Chuan (TCC) has been used in Asian culture for centuries to improve wellness, reduce stress, and to promote healing by improving the flow of Qi. While a number of studies have provided scientific support for these claims in different populations, a beneficial role for TCC in the management of cancer survivors has not been established.
We received a total 233 referrals from PRPL since the study began, 135 of which were referred in the past year since 8/31/07. Of these 233 referrals, 55 (24%) have been enrolled on-study, 13 (6%) are potential candidates currently in the screening process, 53 (23%) were ineligible by phone screen, 12 (5%) are to be re-evaluated later to determine eligibility, and 100 (43%) were not interested, not good candidates, or lost-to-follow-up. Thus, since our last annual report, we have enrolled an additional 37 study participants on-study (49% increase since last year).
Of the total 55 study participants enrolled on-study, 8 of them completed the wait-list control arm and were re-randomized into one of the exercise interventions; thus, there are a total of 63 total evaluable participants. Of these, 36 (57%) completed the 12 week study period, 19 (30%) are in process (2 are completing the current cohort, 10 are enrolled for the fall 2008 cohort, and 7 have requested a future cohort), and 9 (14%) withdrew prior to beginning or while participating on-study.
Of the 9 participants who withdrew, 4 withdrew prior to starting the study (1 due to pregnancy, 2 due to family/work scheduling conflicts, and 1 didn't want to be in the control group) and 5 withdrew while on-study (1 due to worsening plantar fascitis and 4 due to conflicts with work schedule). Three additional participants who completed the wait list control group chose to withdraw participation before re-randomization; their reasons for withdrawing included relocation from the area, scheduling conflicts due to a disabled daughter, and not wanting to be in the cycling arm of the study.
This study aims to compare in a randomized, wait-list controlled design, the efficacy of TCC to an exercise program in improving aerobic exercise capacity and endurance, reducing stress and improving Quality of Life in adult survivors of malignant solid tumors.
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