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Physical Conditioning in Management of Chronic Venous Insufficiency

Primary Purpose

Venous Insufficiency

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Physical Conditioning
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency focused on measuring Venous insufficiency, plethysmography, hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients with severe form of chronic venous insufficiency

Sites / Locations

  • VAMC, East Orange, NJ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 14, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00013273
Brief Title
Physical Conditioning in Management of Chronic Venous Insufficiency
Official Title
Physical Conditioning in Management of Chronic Venous Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
Venous insufficiency, plethysmography, hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Physical Conditioning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with severe form of chronic venous insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fryer, Ph.D. Assistant Director
Organizational Affiliation
Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
First Name & Middle Initial & Last Name & Degree
Wijegupta Ellepola, Program Analyst
Organizational Affiliation
Program Analysis and Review Section (PARS), Rehabilitation Research and Development Service
Facility Information:
Facility Name
VAMC, East Orange, NJ
City
East Orange
State/Province
New Jersey
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Physical Conditioning in Management of Chronic Venous Insufficiency

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