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Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T) Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T) Clinical research trials and Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T) healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T). Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T) Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T) clinical trial. Subjects frequently obtain the most expert healthcare possible for their Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T) condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)  Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)
Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)
For Condition: Vascular Disease
Status: Recruiting
Sponsor(s): Department of Veterans Affairs Rehabilitation Research and Development Service ,
Synopsis: 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.
Details: 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 rehabilitation potential.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Peripheral Vascular Disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WijeguptaEllepola, , Program Analysis and Review Section (PARS), VA Rehabilitation Research and Development Service
VA Medical Center *Recruiting*
Houston, Texas,
United States
Recruiting Jonelle Wright 713-794-7254
Additional Information:
Study ID Numbers: A2830;
Study Start Date: April 2002
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038285
Other Vascular Disease Studies:
1. Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)
2. Effects of Hormone Replacement Therapy on Inflammation and Stiffening of Artery Walls
3. Center for the Study of Vascular Disease in Hispanic and Native Americans
4. Study of Abnormal Blood Clotting in Children with Stroke
Related Studies:
Other Vascular Disease Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)
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