- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00013273
Physical Conditioning in Management of Chronic Venous Insufficiency
January 20, 2009 updated by: US Department of Veterans Affairs
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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East Orange, New Jersey, United States
- VAMC, East Orange, NJ
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Patients with severe form of chronic venous insufficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- John Fryer, Ph.D. Assistant Director, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
- Wijegupta Ellepola, Program Analyst, Program Analysis and Review Section (PARS), Rehabilitation Research and Development Service
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1999
Study Completion (Actual)
December 1, 2001
Study Registration Dates
First Submitted
March 14, 2001
First Submitted That Met QC Criteria
March 15, 2001
First Posted (Estimate)
March 16, 2001
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
January 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A1792R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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