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临床试验/NCT00038285
NCT00038285已完成2 期

Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)

US Department of Veterans Affairs1 个研究点 分布在 1 个国家开始时间: 2002年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
试验地点
1

研究概览

简要总结

In the VA, we are achieving progress in decreasing amputation rates through early identification and multidisciplinary treatment of patients at risk for limb loss. Despite these accomplishments, however, clinical outcomes post-amputation, especially for PVD patients, have changed little because of patients' poor cardiovascular condition complicated by the injurious consequences of imposed inactivity begun in the preoperative period and continuing through convalescence. If not aggressively managed throughout all phases of recovery, these problems quickly render patients, already at risk, incapable of the rigors of rehabilitation as well as lead to reamputation, rehabilitation failure, and secondary complications. In our research, we are trying to transform this clinical scenario by applying what has succeeded in cardiac rehabilitation to services provided to amputees. In a series of studies, we are studying how to incorporate secondary CV risk factor modification and aggressive exercise interventions into conventional amputation rehabilitation through a program that we have named Healthy Heart Amputation Rehabilitation Therapy (Healthy H.A.R.T.). Our goal is to better: 1) increase aerobic capacity and promote rehabilitation achievements and quality of life, and 2) prevent postoperative complications and curtail further peripheral vascular deterioration through interventions found successful in cardiac rehabilitation. The basic assumption of this study will be that cardiovascular status and, thus, aerobic capacity is a most critical factor for rehabilitation success.

详细描述

The overall goal of this line of investigation is to evaluate the efficacy of an integrated cardiovascular amputation rehabilitation program (Healthy Heart Amputation Rehabilitation Therapy (Healthy H.A.R.T.)) that concentrates on secondary CV risk factor modification and utilizes an aggressive exercise program to: 1) increase aerobic capacity and promote rehabilitation achievements and quality of life and 2) prevent postoperative complications and curtail further peripheral vascular deterioration. Given the recognized merits of systematically building upon incremental research achievements to develop comprehensive and multi-faceted clinical programs, we will study the above one step at a time, working up to more wide-scale investigations of the benefits of the integrated Healthy H.A.R.T. program as conceptualized. The following phases are planned:

Part 1 (this proposed 3-year study): examining the clinical effectiveness of Healthy H.A.R.T.'s exercise components. Findings will be disseminated through presentations and publications during and immediately following study completion.

Part 2: revising amputation rehabilitation and P.A.C.T. program care algorithms as indicated by Phase 1 findings.

Part 3: investigating how to implement Healthy H.A.R.T.'s exercise components in distance, off-site, and home-based programs.

Part 4: developing broader scale investigations of additional components of Healthy H.A.R.T. using physiologic and patient care outcome measures, cost-benefit ratios, patient and clinician satisfaction, and service potential offset by resource utilization and expense reports for widespread application.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Fed

研究点 (1)

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