Physical Activity in Children at Risk of Post-thrombotic Syndrome (PACT)
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 7 - 21 |
| Updated: | 2/10/2019 |
| Start Date: | December 2016 |
| End Date: | December 2020 |
| Contact: | Kendra Malone, MPH |
| Email: | kendra.malone@childrens.com |
| Phone: | 214-456-3359 |
Physical Activity in Children at Risk of Post-thrombotic Syndrome: A Pilot Randomized Controlled Trial
'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.
effectiveness of a personal "fitness tracker" to improve adherence to an activity regimen
following an initial acute DVT in children.
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.
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.
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.
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