Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038285
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2002-05-29
Brief Title:
Healthy Heart Amputation Rehabilitation Treatment HART
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Healthy Heart Amputation Rehabilitation Treatment HART
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 HART 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
Detailed Description:
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 HART 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 HART program as conceptualized The following phases are planned
Part 1 this proposed 3-year study examining the clinical effectiveness of Healthy HARTs exercise components Findings will be disseminated through presentations and publications during and immediately following study completion
Part 2 revising amputation rehabilitation and PACT program care algorithms as indicated by Phase 1 findings
Part 3 investigating how to implement Healthy HARTs exercise components in distance off-site and home-based programs
Part 4 developing broader scale investigations of additional components of Healthy HART 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
Key QuestionHypothesis In Healthy HART Part 1 we will test the hypothesis Dysvascular amputees participating in an aggressive exercise program Healthy HART exercise in conjunction with amputation rehabilitation will obtain a greater aerobic capacity and exhibit better rehabilitation achievements and quality of life than those receiving conventional amputation
Experimental Design This study Healthy Heart Amputation Rehabilitation Therapy Healthy HART - Part 1 involves an intent-to-treat designed randomized 2-group pre- and post-intervention study to examine if conventional rehabilitation augmented by Healthy HART exercise a increases aerobic capacity b promotes rehabilitation achievements and c improves quality of life Last cost estimates of the two therapies will be compared
Houston VAMC amputation patients progress through standardized decision making regarding surgery options and level of amputation followed by conventional post-operative medical and surgical care and rehabilitation according to standard VA Amputee Care Algorithm schedules
Standard Decisions on Surgery and Amputation Level Decisions about elective amputations performed by the General Surgery service are made jointly with surgeon and PMR consultation Decisions regarding amputation level are made in light of surgeon-assessed clinical and physiologic signs and patient characteristics and PMR assessments of functionality and patient characteristics such as cognitive function comorbidity and rehabilitation potential
Part 1 this proposed 3-year study examining the clinical effectiveness of Healthy HARTs exercise components Findings will be disseminated through presentations and publications during and immediately following study completion
Part 2 revising amputation rehabilitation and PACT program care algorithms as indicated by Phase 1 findings
Part 3 investigating how to implement Healthy HARTs exercise components in distance off-site and home-based programs
Part 4 developing broader scale investigations of additional components of Healthy HART 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
Key QuestionHypothesis In Healthy HART Part 1 we will test the hypothesis Dysvascular amputees participating in an aggressive exercise program Healthy HART exercise in conjunction with amputation rehabilitation will obtain a greater aerobic capacity and exhibit better rehabilitation achievements and quality of life than those receiving conventional amputation
Experimental Design This study Healthy Heart Amputation Rehabilitation Therapy Healthy HART - Part 1 involves an intent-to-treat designed randomized 2-group pre- and post-intervention study to examine if conventional rehabilitation augmented by Healthy HART exercise a increases aerobic capacity b promotes rehabilitation achievements and c improves quality of life Last cost estimates of the two therapies will be compared
Houston VAMC amputation patients progress through standardized decision making regarding surgery options and level of amputation followed by conventional post-operative medical and surgical care and rehabilitation according to standard VA Amputee Care Algorithm schedules
Standard Decisions on Surgery and Amputation Level Decisions about elective amputations performed by the General Surgery service are made jointly with surgeon and PMR consultation Decisions regarding amputation level are made in light of surgeon-assessed clinical and physiologic signs and patient characteristics and PMR assessments of functionality and patient characteristics such as cognitive function comorbidity and rehabilitation potential
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None