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Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical Trial

Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical Trial
增强退伍军人回忆能力的水基活动:一项随机临床试验
批准号:
10627837
负责人:
Jennifer Kaci Fairchild
金额:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
未结题
起止时间:
2020-07-01 至 2025-06-30
关键词:
Activities of Daily LivingAddressAgeAlzheimer&aposs DiseaseAlzheimer&aposs disease riskAreaAttentionBiologicalBrain-Derived Neurotrophic FactorCardiopulmonaryCardiovascular PhysiologyCardiovascular systemCaringClinicalClinical TrialsCognitionCognitiveDataDementiaDevelopmentEducationEducational MaterialsElderlyEpidemicExclusionExerciseFreedomFutureGenderGeneticGenotypeGuidelinesHealthcare SystemsImpaired cognitionImpairmentInjuryInterventionKnowledgeLightLong-Term EffectsMeasuresMediatingMediatorMedicalMemoryMovementMuscleMusculoskeletalNerve DegenerationNeurodegenerative DisordersNeuropsychologyOutcomeOxygen ConsumptionParticipantPersonsPharmacological TreatmentPhasePhysical ExercisePhysical FitnessPlasmaPopulations at RiskPrevalenceRandomizedRandomized, Controlled TrialsRecommendationRehabilitation therapyResearchRiskShort-Term MemorySingle-Blind StudyStressStructureTestingTrainingTraining ProgramsTreadmill TestsVeteransVisitVulnerable PopulationsWalkingWaterWeight-Bearing stateaccess restrictionsactive methodbrain healthcognitive benefitscognitive functioncognitive trainingcomorbiditycomparative efficacycostdementeddesigneffective therapyefficacious interventionefficacy evaluationexecutive functionexercise capacityexercise programexercise trainingexperienceflexibilityfollow-upfunctional disabilityimprovedlifestyle interventionmeetingsmild cognitive impairmentnon-dementednovelpredicting responsepreventrandomized, clinical trialssuccesstreatment armtreatment as usualtreatment effecttreatment response

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中文摘要
翻译
这项拟议研究的主要研究问题是:是水基运动加上认知 训练干预对改善轻度认知退伍军人认知结果的作用 损害(MCI)?我们通过以下途径解决改善这一弱势群体认知功能的需要 一种新的组合训练计划,将结合两种干预措施:水基运动和认知 训练。拟议的为期四年的随机对照试验将比较基于水的运动认知 培训(水CT)到通常的护理控制条件(UC)。拟议研究的主要目的 目的是评价水CT对改善退伍军人MCI认知功能的效果。次要的 本研究的目的是:1)评价水CT改善血氧峰值的效果 2)评估来自水CT的认知益处的持久性。 拟议研究的探索性目标是评估治疗的调节剂和中介剂。 回应。 这些目标将在单盲随机对照试验中进行测试,该试验将比较 水CT呼叫UC。这项试验将包括190名符合50-90岁MCI标准的退伍军人,其中一半 随机分为水CT组和半随机组。对于水的CT条件,运动 训练(即水)包括为期六个月的水基个人化运动计划 练习。在这一阶段,退伍军人将参加水上疗法每周三次的小组会议 该中心位于退伍军人事务部帕洛阿尔托医疗保健系统(VAPAHCS)。在完成了演习计划之后, 退伍军人将在VAPAHCS开始为期两个月的基于课堂的认知培训。CT是 基于有效的培训计划,该计划围绕两个组成部分构建,即预培训和 助记训练,这两种训练都已成功地用于MCI患者。退伍军人随机 到加州大学控制中心的情况下,除了他们通常的情况外,还将收到关于大脑健康的教育材料 护理,这是他们在退伍军人管理局通常会得到的护理。在完成积极治疗后 阶段,退伍军人将过渡到为期六个月的后续阶段。在长达六个月的 在后续阶段,参与者将返回退伍军人管理局进行最后一次后续访问。 参与者将完成与认知领域相关的各种神经心理测量,例如 注意力、执行功能和记忆力。参与者还将接受身体健康评估 包括6分钟的步行测试和锻炼跑步机测试。研究反应的可能预测因素 治疗期间,我们还将收集生物学(心血管功能和脑源性神经营养因子血浆水平)和基因 来自这些参与者的数据(APOE和BDNF型)。我们希望能提供证据证明其疗效。 运动训练对认知训练的增强,从而为未来的退伍军人保健奠定基础 在全系统范围内部署生活方式干预措施,以预防阿尔茨海默病。
英文摘要
The primary research question of the proposed study is this: Is a water-based exercise plus cognitive training intervention efficacious in improving cognitive outcomes for Veterans with Mild Cognitive Impairment (MCI)? We address the need to improve cognitive function in this vulnerable population through a novel combined training program that will combine two interventions: water-based exercise and cognitive training. The proposed four-year randomized controlled trial will compare water-based exercise + cognitive training (WATER+CT) to a Usual Care Control Condition (UC). The primary aim of the proposed research is to evaluate the efficacy of WATER+CT to improve cognitive function in Veterans with MCI. Secondary aims of the proposed research are: 1) to evaluate the efficacy of WATER+CT to improve peak oxygen consumption and 2) to evaluate the durability of the cognitive benefits derived from WATER+CT. Exploratory aims of the proposed research are to evaluate moderators and mediators of treatment response. These aims will be tested in a single-blind randomized controlled trial that will compare the efficacy of WATER+CT to UC. This trial will include 190 Veterans meeting criteria for MCI age 50-90 with half randomized to WATER+CT and half randomized to UC. For the WATER+CT condition, the exercise training (i.e., WATER) consists of a six-month long individualized exercise program of water-based exercises. During this phase, Veterans will come to thrice-weekly group sessions at Aquatic Therapy Center at the VA Palo Alto Health Care System (VAPAHCS). After completion of the exercise program, Veterans will begin classroom-based cognitive training at the VAPAHCS for up to two months. The CT is based on an efficacious training program that is structured around two components, pre-training and mnemonic training, both of which have been used successfully in persons with MCI. Veterans randomized to the UC control condition will receive educational materials about brain health in addition to their usual care, which is the care they would typically receive in the VA. After completion of the active treatment phase, Veterans will transition to the six-month long follow-up phase. At the end of the six-month long follow-up phase, participants will return to the VA for a final follow-up visit. Participants will complete a variety of neuropsychological measures taping into areas of cognition such as attention, executive functioning, and memory. Participants will also undergo physical fitness assessments including a 6-minute walk test and an exercise treadmill test. To study possible predictors of response to treatment, we will also collect biological (cardiovascular functioning and BDNF plasma levels) and genetic data (APOE and BDNF genotypes) from these participants. We hope to provide evidence of the efficacy of an exercise training augmentation for cognitive training thus laying the groundwork for future VA health care system wide deployment of a lifestyle intervention to prevent Alzheimer’s disease.
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Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical Trial
Water-based Activity to Enhance Recall in Veterans: A Randomized Clinical Trial
Water-based Activities to Enhance Recall in Veterans (WATER-VET)
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