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

NCT00038285 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2009-01-21

No results posted yet for this study

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 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.

Conditions

  • Vascular Disease

Interventions

PROCEDURE

Amputation Prevention

Sponsors & Collaborators

Principal Investigators

  • David Wolff, Ph.D. Special Assistant to the Director · Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service

  • Wijegupta Ellepola, Program Analyst · Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Completion
2005-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00038285 on ClinicalTrials.gov