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Home > "P" Clinical Trials Conditions > Physical Conditioning in Management of Chronic Venous Insufficiency  Physical Conditioning in Management of Chronic Venous Insufficiency
Physical Conditioning in Management of Chronic Venous Insufficiency
For Condition: Venous Insufficiency
Status: No longer recruiting
Sponsor(s): Department of Veterans Affairs ,
Synopsis: The purpose of this research is to evaluate the efficacy of a structured program of physical therapy in ameliorating the adverse consequeces of Chronic Venous Insufficiency (CVI). The study will also investigate the interrelationship among measure of chronic venous diseses: lower limb muscle strength, mobility, and other symptons 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Patients with severe form of chronic venous insufficiency
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
JohnFryer, , Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
VAMC, East Orange, NJ
East Orange, New Jersey,
United States
Additional Information:
Study ID Numbers: A1792;
Study Start Date: January 1999
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00013273
Other Venous Insufficiency Studies:
1. Physical Conditioning in Management of Chronic Venous Insufficiency
Related Studies:
Other Venous Insufficiency Clinical Trials
Other New Jersey Clinical Trials
Other East Orange Clinical Trials
Physical Conditioning in Management of Chronic Venous Insufficiency
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