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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 14, 2001 | ||||||||
| Last Updated Date | January 20, 2009 | ||||||||
| Start Date ICMJE | January 1999 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00013273 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Physical Conditioning in Management of Chronic Venous Insufficiency | ||||||||
| Official Title ICMJE | Physical Conditioning in Management of Chronic Venous Insufficiency | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Venous Insufficiency | ||||||||
| Intervention ICMJE | Procedure: Physical Conditioning | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | December 2001 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Patients with severe form of chronic venous insufficiency |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00013273 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | A1792R | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | January 2001 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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