Physical Conditioning in Management of Chronic Venous Insufficiency
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Purpose
The purpose of this research is to evaluate the efficacy of a structured program of physical therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). The study will also investigate the interrelationship among measure of chronic venous diseases: lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of life. Sixty patients will be randomized to a 6 months physical therapy program or to a control group.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Insufficiency |
Procedure: Physical Conditioning |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Physical Conditioning in Management of Chronic Venous Insufficiency |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 1999 |
| Study Completion Date: | December 2001 |
The purpose of this research is to evaluate the efficacy of a structured program of physical therapy in ameliorating the adverse consequences of Chronic Venous Insufficiency (CVI). A secondary purpose is to investigate the interrelationship among measure of chronic venous diseases: lower limb muscle strength, mobility, and other symptoms of CVI important to the quality of life. Sixty patients will be randomized to a 6 months physical therapy program or to a control group. All subjects will undergo a complete hemodynamic and psychiatric assessment. Key measures will be repeated twice to quantify trend and stability of the baseline measures. Skin biopsies will be obtained in selected patients who demonstrate a response to the physical therapy to evaluate the ultrastructural response therapy. Physical therapy will be conducted 1-3 times per week. Participants will be visited at home and a program will be tailored for each individual to maximize compliance. Validated, standardized questionnaires (FIM, SF-36, OARS, CHART) and functional ratings will be employed at commencement,3,6 and 12 months. Evaluations of hydrodynamics, muscle strength, and ankle motion will be conducted monthly during active physical therapy. Participants in active therapy will be offered to wait listed control group after 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients with severe form of chronic venous insufficiency
Contacts and Locations| United States, New Jersey | |
| VAMC, East Orange, NJ | |
| East Orange, New Jersey, United States | |
| Investigator: | John Fryer, Ph.D. Assistant Director | Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service |
| Investigator: | Wijegupta Ellepola, Program Analyst | Program Analysis and Review Section (PARS), Rehabilitation Research and Development Service |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00013273 History of Changes |
| Other Study ID Numbers: | A1792R |
| Study First Received: | March 14, 2001 |
| Last Updated: | January 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Venous insufficiency, plethysmography, hypertension |
Additional relevant MeSH terms:
|
Venous Insufficiency Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013