Clinical Trial: Physical Activity in Children at Risk of Post-thrombotic Syndrome (PACT)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Physical Activity in Children at Risk of Post-thrombotic Syndrome: A Pilot Randomized Controlled Trial

Brief Summary: 'The PACT trial' is randomized pilot trial to demonstrate the feasibility and potential effectiveness of a personal "fitness tracker" to improve adherence to an activity regimen following an initial acute DVT in children.

Detailed Summary:

The feasibility of an innovative intervention of a validated fitness tracker, the Fitbit, to improve adherence to a 12-week activity regimen in a pilot randomized controlled trial (RCT) will be tested in 44 subjects with first, acute, proximal lower extremity deep vein thrombosis (DVT).

The primary outcomes will consist of a) feasibility indicators determined a priori (eligibility, consent, adherence, retention) and b) estimates of effect size associated with the prescribed activity regimen, by describing within-subject change in QoL and potential biomarkers of postthrombotic syndrome (PTS) pre and post intervention in each group.


Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome:

  • Proportion of screened patients who meet eligibility criteria [ Time Frame: Within 9 months ]
    Feasibility criteria met when assessed to be ≥ 30%
  • Proportion of eligible patients who provide consent [ Time Frame: Within 9 months ]
    Feasibility criteria met when assessed to be ≥ 30%
  • Level of adherence in the FitBit arm [ Time Frame: Within 6 months of randomization ]
    Feasibility criteria met when assessed to be ≥ 60%
  • Proportion of subjects who complete the trial post randomization [ Time Frame: Within 6 months of randomization ]
    Feasibility criteria met when assessed to be ≥ 80%


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in PTS biomarkers pre and post intervention of increased physical activity as measured by markers of coagulation activation, inflammation and fibrinolysis [ Time Frame: Within 6 months of randomization ]
    Markers of coagulation activation as assessed by D-dimer, FVIII; inflammation as assessed by C-reactive protein and markers of fibrinolysis as assessed by PAI-1, in addition to global coagulation assays, namely thrombin generation and TEG-fibrinolysis
  • Change in Quality of Life [ Time Frame: Within 6 months of randomization ]
    As assessed by PedsQL instrument


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: April 20, 2016
Date Started: December 2016
Date Completion: December 2019
Last Updated: March 3, 2017
Last Verified: February 2017