EFFECT OF BODY COOLING BY RTX ON MOTOR FUNCTION IN HEAT-SENSITIVE MS PATIENTS
EFFECT OF BODY COOLING BY RTX ON MOTOR FUNCTION IN HEAT-SENSITIVE MS PATIENTS
批准号:
7603791
负责人:
DANIEL D MIKOL
金额:
$0.27万
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-03-01 至 2007-09-16
关键词:
Aerobic ExerciseAthleticBody TemperatureComputer Retrieval of Information on Scientific Projects DatabaseCool-X-ACross-Over StudiesDevicesDouble-Blind MethodExclusion CriteriaExerciseFatigueFundingGrantHeatingIndividualInstitutionLeftMotorMultiple SclerosisNumbersPatientsPerformancePilot ProjectsRecruitment ActivityResearchResearch PersonnelResiniferatoxinResourcesScreening procedureSourceStudy SubjectTestingTimeUnited States National Institutes of HealthUpper ExtremityUpper armVacuumVisitWalkingdaydisabilityfootgraspimprovedpressureresponse
中文摘要
这个子项目是许多研究子项目中利用
资源由NIH/NCRR资助的中心拨款提供。子项目和
调查员(PI)可能从NIH的另一个来源获得了主要资金,
并因此可以在其他清晰的条目中表示。列出的机构是
该中心不一定是调查人员的机构。
这项双盲对照试点研究的目的是评估一种核心冷却装置是否能提高非多发性硬化症(MS)患者的运动能力,并改善中重度残疾的热敏性MS患者的运动功能和有氧运动能力。24名符合纳入/排除标准的受试者将接受筛查(下午1点之间)。和下午4点),能够在筛查时完成运动任务和锻炼的人将在另外两个下午(下午1点之间)接受评估。和下午4点)相隔5-14天。如果一名研究对象未能完成筛选评估和研究的第一天和第二天,将增聘一名研究对象,以便24名研究对象完成研究。在这项双盲交叉研究中,每个人将作为自己的对照(每个交叉臂12个)。
在每次就诊时,患者将进行一系列的运动评估(9孔钉子测试[右和左]、计时25英尺步行、握力测功法[右和左])和使用Monark测力计进行上肢锻炼,直到他们感到中度疲劳(博格量表)。筛查时,将进行运动评估和锻炼,但不使用掌侧真空冷却装置(AvaCore“B”装置)。不能完成这些筛查任务的受试者将被排除在进一步测试之外。
在访问1号和2号时,一些评估将在假(无真空)或真空冷却15分钟后进行,具体如下。假冷却(不带真空的冷却)起到了负面控制作用。研究表明,在没有真空施加负压的情况下,手掌动静脉网只对寒冷做出反应,对核心体温几乎没有影响。
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
The objective of this double-blind controlled pilot study is to assess whether a core cooling device that has been shown to augment athletic performance in individuals without multiple sclerosis (MS) improves motor function and aerobic exercise capacity in heat-sensitive MS patients with moderate-severe disability. 24 subjects who fulfill inclusion/exclusion criteria will be seen at screening (between 1 p.m. and 4 p.m.), and individuals able to complete the motor tasks and exercise at screening will then be evaluated on two additional afternoons (between 1 p.m. and 4 p.m.) 5-14 days apart. If a study subject is unable to complete the screening assessment and study days 1 and 2, an additional subject will be recruited, such that 24 subjects will complete the study. Individuals will serve as their own controls in this double-blind crossover study (12 in each crossover arm).
At each of the visits, patients will carry out a number of motor assessments (9-hole peg testing [right and left], timed 25-foot walk, grip strength by dynamometry [right and left]) and upper extremity exercise with a Monark ergometer until they feel moderately fatigued (Borg scale). At screening, the motor assessments and exercise will be performed, but the palmar vacuum cooling device (AvaCore "B" unit) will not be utilized. Subjects not able to complete these screening tasks will be excluded from further testing.
At visits #1 and #2, some assessments will be carried out after sham- (no vacuum) or vacuum-cooling for 15 minutes, as detailed below. Sham-cooling (cooling without vacuum) serves as a negative control. Studies have shown that without the vacuum applying negative pressure, the palmar arteriovenous network constricts in response to cold alone, with little if any effect on core body temperature.'
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