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.
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.
Key Question/Hypothesis: In Healthy H.A.R.T. Part 1, we will test the hypothesis:
Dysvascular amputees participating in an aggressive exercise program (Healthy H.A.R.T.
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
H.A.R.T. 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 PM&R
consultation. Decisions regarding amputation level are made in light of surgeon-assessed
clinical and physiologic signs and patient characteristics and PM&R assessments of
functionality and patient characteristics such as cognitive function, comorbidity, and
Peripheral Vascular Disease
David Wolff, Ph.D. Special Assistant to the Director
Program Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service