Physical Conditioning in Management of Chronic Venous Insufficiency

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00013273
First received: March 14, 2001
Last updated: January 20, 2009
Last verified: January 2001

March 14, 2001
January 20, 2009
January 1999
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Complete list of historical versions of study NCT00013273 on ClinicalTrials.gov Archive Site
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Physical Conditioning in Management of Chronic Venous Insufficiency
Physical Conditioning in Management of Chronic Venous Insufficiency

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Insufficiency
Procedure: Physical Conditioning
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2001
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Patients with severe form of chronic venous insufficiency

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00013273
A1792R
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Department of Veterans Affairs
Not Provided
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
Department of Veterans Affairs
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP