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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Department of Veterans Affairs:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients with severe form of chronic venous insufficiency

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00013273

Locations
United States, New Jersey
VAMC, East Orange, NJ
East Orange, New Jersey, United States
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00013273     History of Changes
Other Study ID Numbers: A1792R
Study First Received: March 14, 2001
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Venous insufficiency, plethysmography, hypertension

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014