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Physical Conditioning in Management of Chronic Venous Insufficiency

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00013273
First Posted: March 16, 2001
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
VA Office of Research and Development
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Conditioning in Management of Chronic Venous Insufficiency

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Estimated Enrollment: 60
Study Start Date: January 1999
Study Completion Date: December 2001
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Patients with severe form of chronic venous insufficiency
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00013273


Locations
United States, New Jersey
VAMC, East Orange, NJ
East Orange, New Jersey, United States
Sponsors and Collaborators
VA Office of Research and Development
Investigators
OverallOfficial: John Fryer, Ph.D. Assistant Director Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
OverallOfficial: Wijegupta Ellepola, Program Analyst Program Analysis and Review Section (PARS), Rehabilitation Research and Development Service
  More Information

ClinicalTrials.gov Identifier: NCT00013273     History of Changes
Other Study ID Numbers: A1792R
First Submitted: March 14, 2001
First Posted: March 16, 2001
Last Update Posted: January 21, 2009
Last Verified: January 2001

Keywords provided by VA Office of Research and Development:
Venous insufficiency, plethysmography, hypertension

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases