EFFECT OF BODY COOLING BY RTX ON MOTOR FUNCTION IN HEAT-SENSITIVE MS PATIENTS

RTX 身体冷却对热敏性多发性硬化症患者运动功能的影响

• 批准号: 7603791
• 负责人: DANIEL D MIKOL
• 金额: $ 0.27万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603791
• 关键词: Aerobic Exercise; Athletic; Body Temperature; Computer Retrieval of Information on Scientific Projects Database; Cool-X-A; Cross-Over Studies; Devices; Double-Blind Method; Exclusion Criteria; Exercise; Fatigue; Funding; Grant; Heating; Individual; Institution; Left; Motor; Multiple Sclerosis; Numbers; Patients; Performance; Pilot Projects; Recruitment Activity; Research; Research Personnel; Resiniferatoxin; Resources; Screening procedure; Source; Study Subject; Testing; Time; United States National Institutes of Health; Upper Extremity; Upper arm; Vacuum; Visit; Walking; day; disability; foot; grasp; improved; pressure; response

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.'

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项双盲对照初探性研究的目的是评估已被证明可以增强非多发性硬化症（MS）患者运动表现的核心冷却装置是否可以改善中重度残疾的热敏感MS患者的运动功能和有氧运动能力。 将在筛选时（下午1点至4点）观察24例符合入选/排除标准的受试者，并且能够在筛选时完成运动任务和锻炼的个人将在另外两个下午（下午1点至4点之间）接受评估5-14相隔几天 如果研究受试者无法完成筛选评估以及研究第1天和第2天，则将招募额外的受试者，这样24例受试者将完成研究。 在本双盲交叉研究中，个体将作为其自身对照（每个交叉组12例）。 在每次访视时，患者将进行多次运动评估（9孔桩测试[右侧和左侧]、定时25英尺步行、测力计测定的握力[右侧和左侧]），并使用Monark测力计进行上肢运动，直至患者感到中度疲劳（博格量表）。 筛选时，将进行运动评估和运动，但将不使用手掌真空冷却装置（AvaCore“B”装置）。 无法完成这些筛选任务的受试者将被排除在进一步检测之外。 在访视#1和#2时，将在假手术（无真空）或真空冷却15分钟后进行一些评估，如下所述。 假冷却（无真空冷却）作为阴性对照。 研究表明，在没有施加负压的真空的情况下，手掌动静脉网络仅对寒冷做出反应而收缩，对核心体温几乎没有影响。'