NCT00910364

Brief Summary

The purpose of this pilot study is to assess the feasibility of determining the effects of a structured exercise program started two to four weeks after diagnosis of a first episode lower-extremity deep vein thrombosis (DVT) for a period of 12 weeks in reducing the incidence of post-thrombotic syndrome (PTS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

4.2 years

First QC Date

May 28, 2009

Last Update Submit

April 11, 2017

Conditions

Deep Vein Thrombosis

Keywords

Lower extremity DVTClotleg clotDeep vein thrombosisThrombosisWarfarin

Outcome Measures

Primary Outcomes (1)

  • Villalta PTS score

    at 26 weeks

Secondary Outcomes (1)

  • PTS, venous valvular reflux, VEINES, MOS SF-36, maximal treadmill test, 6-minute walk, and blood analysis

    at 12 weeks

Study Arms (1)

Exercise testing

EXPERIMENTAL

Feasibility study; all participants receive intervention

Other: Exercise

Interventions

ExerciseOTHER

Exercise

Exercise testing

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First episode lower extremity DVT (proximal or distal) documented by ultrasound, CT angiogram or venogram within last 4 weeks.
  • Treatment with LMWH, or unfractionated heparin (UFH) followed by warfarin adjusted to keep INR 2 to 3 for at least 3 months, or LMWH given in therapeutic doses as sole therapy.
  • Age 21 to 75 years old.

You may not qualify if:

  • Recurrent DVT.
  • Treatment of DVT with systemic or catheter-directed thrombolysis Contraindications to exercise training according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.,).
  • Life expectancy \< 1 year.
  • Pregnancy.
  • Geographic inaccessibility.
  • Cognitive dysfunction assessed by mini-mental status exam (score \< 24).
  • Inability to walk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Venous ThrombosisThrombosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Suman W. Rathbun, M.D.

    Oklahoma University Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 28, 2009

First Posted

May 29, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

US(1)