NCT03075761

Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 7 Years – 21 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Post Thrombotic Syndrome
• Deep Vein Thrombosis

Interventions

Type	Name	Description
DEVICE	Fitbit	The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.
BEHAVIORAL	30-minute education session

Timeline

• Start date: 2016-11-18
• Primary completion: 2019-10-09
• Completion: 2019-10-10
• First posted: 2017-03-09
• Last updated: 2021-05-18
• Results posted: 2021-05-18

Locations

1 site across 1 country: United States