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

The University of Texas System (UT)

Status: Completed

Conditions: Post Thrombotic Syndrome; Deep Vein Thrombosis

Treatments: Behavioral: 30-minute education session; Device: Fitbit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03075761

1K23HL132054-01 (U.S. NIH Grant/Contract)

STU 022016-057

Details and patient eligibility

About

'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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 7 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants randomized to the intervention arm will receive a Fitbit, formal 30-minute education session on post-thrombotic syndrome (PTS) and benefits of increased physical activity. An individualized activity prescription will be provided and participants will be asked to maintain the target level of activity for 12 weeks after determining their habitual activity in the first 4 weeks.

Treatment:

Device: Fitbit

Behavioral: 30-minute education session

Control

Active Comparator group

Description:

Participants randomized to the control arm will receive a formal 30-minute education session on post-thrombotic syndrome (PTS) and the benefits of increased physical activity. Their physical activity will be self-reported in an activity log and by the Gordin activity questionnaire over the 16-week intervention period.

Treatment:

Behavioral: 30-minute education session