Clinical trial NCT03075761: Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)
Official title: Physical Activity in Children at Risk of Post-thrombotic Sequelae: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Thrombotic Syndrome
Deep Vein Thrombosis
Keywords: Venous thromboembolism
Deep Vein Thrombosis
Lower Extremity
Blood clot
Anticoagulation
Physical Activity
Fitbit
Post-thrombotic syndrome
Post-phlebitic syndrome
Thrombosis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Texas Scottish Rite Hospital for Children
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-03-09
Enrollment: 111
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Primary outcomes:
measure: Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline
timeFrame: Baseline
measure: Number of Screened Subjects Who Provided Consent at Baseline
timeFrame: Baseline
measure: Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm )
timeFrame: 8 weeks
measure: Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only)
timeFrame: 3 months
measure: Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only)
timeFrame: 6 months
measure: Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only)
timeFrame: 9 months
measure: Proportion of Subjects Who Complete Post-randomization
timeFrame: Within 24 months of trial initiation
Secondary outcomes:
measure: Change in PTS Biomarkers (D-dimer)
timeFrame: From baseline to 6 months
measure: Percentage Change From Baseline in FVIII PTS Biomarker
timeFrame: From baseline to 6 month
measure: Change in PTS Biomarkers (C-reactive Protein)
timeFrame: From baseline to 6 month
measure: Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential)
timeFrame: From baseline to 6 month
measure: Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation)
timeFrame: From baseline to 6 month
measure: Percent Change in Fibrinolysis Biomarker
timeFrame: From baseline to 6 month
measure: Change in Quality of Life
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Ayesha Zia, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hasan R, Hanna M, Zhang S, Malone K, Tong E, Salas N, Sarode R, Journeycake J, Zia A. Physical activity in children at risk of postthrombotic sequelae: a pilot randomized controlled trial. Blood Adv. 2020 Aug 11;4(15):3767-3775. doi: 10.1182/bloodadvances.2020002096.