CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
Fitbit +1 moredevice
Likely dose
Fitbit device with 12-week activity regimen and 30-minute education sessionAI-extracted
Key inclusion· 3
  • ✓Radiologically confirmed acute proximal first lower extremity DVT
  • ✓4 to 8 weeks after starting anticoagulation
  • ✓Out-patient ambulatory status
Key exclusion· 1
  • ✕Contraindication to increasing activity (e.g. juvenile arthritis, poor balance, congestive heart failure)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03075761
NCT03075761N/ACompleted
CompareCT.gov

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

University of Texas Southwestern Medical Center·interventional·Posted Mar 9, 2017·Updated May 18, 2021

In Brief

A clinical study evaluating Fitbit and 30-minute education session for Post Thrombotic Syndrome and Deep Vein Thrombosis. Completed, enrolled 111 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Thrombotic Syndrome, Deep Vein Thrombosis
CountriesUnited States
CollaboratorsTexas Scottish Rite Hospital for Children, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 9, 2017
Enrollment StartNov 18, 2016
Primary CompletionOct 9, 2019
Study CompletionOct 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.3 years ago

Interventions

Fitbitdevice

The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.

30-minute education sessionbehavioral