MECHANISMS OF IMPROVEMENT IN RESPONSE TO AEROBIC TRAINING IN CLAUDICATION PATIEN

跛行患者有氧训练反应的改善机制

• 批准号: 7951715
• 负责人: DIANE J TREATJACOBSON
• 金额: $ 1.17万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951715
• 关键词: Aerobic; Affect; Ankle; Blood Vessels; Blood flow; Blood specimen; Cardiopulmonary; Clinical; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Development; Ergometry; Evaluation; Exclusion Criteria; Exercise; Exercise stress test; Funding; Grant; Hemostatic function; Individual; Injury; Institution; Intervention; Investigation; Laboratories; Life Style; Lower Extremity; Measurement; Measures; Mediating; Medical History; Methods; Morbidity - disease rate; Nature; Outcome; Outcome Study; Pain; Patients; Peripheral arterial disease; Physiological; Population; Randomized; Relative (related person); Reporting; Research; Research Personnel; Resources; Screening procedure; Source; Symptoms; Thrombosis; Time; Training; Treadmill Tests; United States National Institutes of Health; Upper arm; Vasodilation; Walking; brachial artery; claudication; effective intervention; functional status; improved; indexing; meetings; mortality; primary outcome; programs; response; treatment as usual

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. Peripheral Arterial Disease (PAD) affects approximately 9 million individuals in the US and is associated with significant morbidity and mortality. Symptoms of PAD are related to insufficient arterial blood flow, which results in exercise-induced ischemic pain (claudication) Supervised exercise training, particularly treadmill training, is recognized as an effective intervention to improve walking distance in this population. One study has demonstrated that aerobic arm training alone improved walking distance in patients with claudication. This proposal builds on an ongoing study (ETC-I) assessing the relative effects of a 12-week program of upper body versus lower body aerobic training (either alone or in combination) on exercise capacity and functional status in patients with lifestyle limiting claudication. The primary outcomes for that study are essentially clinical in nature (changes in walking distance and functional status). Preliminary data indicate that subjects performing upper body aerobic training are demonstrating substantial improvement in walking ability, similar to those performing lower body aerobic training. This finding suggests a systemic as opposed to local mechanism of exercise-related improvement. The current study (ETC-II) will examine underlying physiological mechanisms to explain (and measure) the clinical changes currently being observed in our claudication subjects. It will include assessment of the effect of exercise on more basic physiological variables associated with endothelial injury and thrombosis/hemostasis. It will allow measurement of changes in these factors with exercise training and evaluation of differences between those engaging in upper body (non-ischemic) versus lower body (ischemic) exercise. This will provide evidence to tie the clinical outcomes seen with exercise training to physiologic mechanisms and provide direction for development of improved interventions in this population. Primary Objective: To determine the relative effects of a 12-week supervised program of treadmill exercise training or arm ergometry, alone or in combination, versus ¿usual care¿ in subjects with claudication on systemic physiologic measures associated with endothelial injury and thrombosis/hemostasis. The primary outcome is change in flow-mediated vasodilation (FMD) of the brachial artery. Hypotheses include: ¿ Both upper and lower extremity training will result in improvement in (FMD), as well as improvements in systemic markers of endothelial injury and thrombosis/hemostasis, when compared with control subjects receiving ¿usual care¿. ¿ Exercise-induced improvements in maximal walking distance will be positively related to changes in these systemic physiologic measures. Secondary Objective: To determine which physiological markers are most appropriate for inclusion in a subsequent clinical trial and to gather preliminary data that determines effect sizes, thus allowing power calculations for subsequent investigations. Methods: Patients will undergo screening including medical history, measurement of the ankle brachial index (ABI), and a cardiopulmonary exercise test. Subjects who meet inclusion/exclusion criteria will be evaluated in the GCRC on two separate days. These evaluations include blood sampling before and after a symptom-limited graded treadmill test and evaluation of vascular function. Following completion of all screening procedures, subjects will be randomly assigned to one of 4 groups: (1) Control, (2) Treadmill Walking, (3) Arm Ergometry, or (4) Combined Arm Ergometry and Treadmill Walking for a 12 week study period. Exercise subjects perform 60 minutes of supervised exercise in the exercise laboratory 3 times per week for 12 weeks. Control subjects continue "usual care" and report to the exercise laboratory once a week for vital sign evaluation and encouragement. All measurements will be repeated within 1 week of completion of the exercise program.

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。 外周动脉疾病（PAD）影响美国约900万人，并与显著的发病率和死亡率相关。PAD的症状与动脉血流量不足有关，导致运动诱发的缺血性疼痛（跛行）监督运动训练，特别是跑步机训练，被认为是改善该人群步行距离的有效干预措施。一项研究表明，有氧手臂训练单独改善跛行患者的步行距离。该提案建立在一项正在进行的研究（ETC-I）的基础上，该研究评估了为期12周的上身与下身有氧训练（单独或联合）对生活方式限制性跛行患者运动能力和功能状态的相对影响。该研究的主要结局基本上是临床性质的（步行距离和功能状态的变化）。初步数据表明，进行上半身有氧训练的受试者表现出步行能力的显著改善，与进行下半身有氧训练的受试者相似。这一发现表明一个系统的，而不是局部机制的运动相关的改善。本研究（ETC-II）将检查潜在的生理机制，以解释（和测量）目前在我们的跛行受试者中观察到的临床变化。它将包括评估运动对与内皮损伤和血栓形成/止血相关的更基本生理变量的影响。它将允许测量这些因素与运动训练的变化，并评估那些从事上半身（非缺血性）与下半身（缺血性）运动之间的差异。这将提供证据，将运动训练的临床结果与生理机制联系起来，并为在该人群中开发改进的干预措施提供方向。 主要目的：在跛行受试者中，确定12周跑步机运动训练或手臂测力计（单独或联合）监督计划与常规护理相比，对与内皮损伤和血栓形成/止血相关的全身生理指标的相对影响。 主要结局是肱动脉血流介导的血管舒张（FMD）的变化。假设包括： ¿ 与接受常规护理的对照受试者相比，上肢和下肢训练将导致FMD改善，以及内皮损伤和血栓形成/止血的全身标志物改善。 ¿ 运动诱导的最大步行距离的改善与这些全身生理指标的变化呈正相关。 次要目的：确定哪些生理标志物最适合纳入后续临床试验，并收集确定效应量的初步数据，从而为后续研究提供把握度计算。 研究方法：患者将接受筛选，包括病史、踝臂指数（ABI）测量和心肺运动试验。符合入选/排除标准的受试者将在GCRC中接受两天评价。 这些评估包括血液采样之前和之后的限幅分级跑台试验和血管功能的评估。完成所有筛选程序后，受试者将被随机分配至4组之一：（1）对照组，（2）跑步机行走组，（3）手臂测力组，或（4）手臂测力和跑步机行走联合组，研究期为12周。 运动受试者在运动实验室进行60分钟的监督运动，每周3次，持续12周。对照受试者继续“常规护理”，每周一次到运动实验室报告，进行生命体征评估和鼓励。所有测量将在运动计划完成后1周内重复进行。