NCT00013273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2001

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2001

First QC Date

March 14, 2001

Last Update Submit

January 20, 2009

Conditions

Venous Insufficiency

Keywords

Venous insufficiency, plethysmography, hypertension

Interventions

Physical ConditioningPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Patients with severe form of chronic venous insufficiency

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

VAMC, East Orange, NJ

East Orange, New Jersey, United States

Location

MeSH Terms

Conditions

Venous InsufficiencyHypertension

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • 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 Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

March 14, 2001

First Posted

March 16, 2001

Study Start

January 1, 1999

Study Completion

December 1, 2001

Last Updated

January 21, 2009

Record last verified: 2001-01

Locations

US(1)