N/A
Completed N=23
Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)
Source: ClinicalTrials.gov NCT03075761 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline — 40 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline |
40 | — |
| PRIMARY Number of Screened Subjects Who Provided Consent at Baseline |
23 | — |
| PRIMARY Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm ) |
3 | — |
| PRIMARY Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only) |
56 | — |
| PRIMARY Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only) |
52 | — |
| PRIMARY Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only) |
38 | — |
| PRIMARY Proportion of Subjects Who Complete Post-randomization |
10; 6 | — |
| SECONDARY Change in PTS Biomarkers (D-dimer) |
-4675; -6241 | — |
| SECONDARY Percentage Change From Baseline in FVIII PTS Biomarker |
-39.6; -50.4 | — |
| SECONDARY Change in PTS Biomarkers (C-reactive Protein) |
-0.4; -0.6 | — |
| SECONDARY Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential) |
41.0; -60.1 | — |
| SECONDARY Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation) |
60.5; 0.2 | — |
| SECONDARY Percent Change in Fibrinolysis Biomarker |
-0.05; 2.1; -0.04; 6.2 | — |
| SECONDARY Change in Quality of Life |
5.4; 24.5 | — |
Eligibility Criteria
Inclusion Criteria
- A radiologically confirmed, acute, proximal first lower extremity DVT
- 4 to 8 weeks after starting anticoagulation
- Out-patient ambulatory status
Exclusion Criteria
- Contraindication to increasing activity such as patients with juvenile arthritis, poor balance, congestive heart failure, etc.
Data sourced from ClinicalTrials.gov (NCT03075761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.