Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013273
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-03-14
Brief Title:
Physical Conditioning in Management of Chronic Venous Insufficiency
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Physical Conditioning in Management of Chronic Venous Insufficiency
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 commencement36 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None