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

Study Overview
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Brief Summary
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'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
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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.

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

Conditions
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Post Thrombotic Syndrome, Deep Vein Thrombosis

Intervention / Treatment
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* Device: Fitbit
* Behavioral: 30-minute education session


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Device: Fitbit<br>* The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.<br>* Other names: Activity tracker;Behavioral: 30-minute education session<br> <br> |
| Active Comparator: Control<br>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. | Behavioral: 30-minute education session<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline | Feasibility criteria for rate of study eligibility met when assessed to be ≥ 30% INCLUSION CRITERIA: 1.) Age 7-21 years 2.)2. A radiologically confirmed, acute, proximal (iliofemoral and femoropopliteal) first lower extremity DVT and/or confirmed, acute pulmonary embolism (unilateral or bilateral) 3.) 12 weeks (±2 weeks) after starting anticoagulation 4.) Out-patient ambulatory status | Baseline | 
| Number of Screened Subjects Who Provided Consent at Baseline | Feasibility criteria for rate of consent was assessed to be ≥ 30% at baseline INCLUSION CRITERIA: 1.) Age 7-21 years 2.)2. A radiologically confirmed, acute, proximal (iliofemoral and femoropopliteal) first lower extremity DVT and/or confirmed, acute pulmonary embolism (unilateral or bilateral) 3.) 12 weeks (±2 weeks) after starting anticoagulation 4.) Out-patient ambulatory status | Baseline | 
| Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm ) | Adherence in the physical activity group is calculated based on the number of participants who complied with the target weekly goal or activity prescription during the active 8-week period. | 8 weeks | 
| Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only) | The Godin-Shephard Leisure-Time Physical Activity Questionnaire was used to quantify physical activity levels. Individuals reporting moderate-to-strenuous activity levels ≥24 were classified as active (better outcome), whereas individuals reporting moderate-to-strenuous activity levels ≤23 were classified were insufficiently active (worse outcome). | 3 months | 
| Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only) | The Godin-Shephard Leisure-Time Physical Activity Questionnaire was used to quantify physical activity levels. Individuals reporting moderate-to-strenuous activity levels ≥24 were classified as active (better outcome), whereas individuals reporting moderate-to-strenuous activity levels ≤23 were classified were insufficiently active (worse outcome). | 6 months | 
| Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only) | The Godin-Shephard Leisure-Time Physical Activity Questionnaire was used to quantify physical activity levels. Individuals reporting moderate-to-strenuous activity levels ≥24 were classified as active (better outcome), whereas individuals reporting moderate-to-strenuous activity levels ≤23 were classified were insufficiently active (worse outcome). | 9 months | 
| Proportion of Subjects Who Complete Post-randomization | Feasibility criteria is met when assessed to be ≥ 80%. This includes the number of subjects who successfully completed the trial. | Within 24 months of trial initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTS Biomarkers (D-dimer) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by coagulation activation marker D-dimer. | From baseline to 6 months | 
| Percentage Change From Baseline in FVIII PTS Biomarker | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by the coagulation activation marker FVIII | From baseline to 6 month | 
| Change in PTS Biomarkers (C-reactive Protein) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by inflammation marker C-reactive protein (CRP) using a latex-enhanced immunoturbidimetric assay. | From baseline to 6 month | 
| Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by endogenous thrombin potential using calibrated automated thrombogram (CAT). CAT is a routine test that measures hyper- and hypocoagulability. | From baseline to 6 month | 
| Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation) | Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by thrombin generation assay using calibrated automated thrombogram (CAT). CAT is a routine test that measures hyper- and hypocoagulability. | From baseline to 6 month | 
| Percent Change in Fibrinolysis Biomarker | Percent Change in Fibrinolysis Biomarker from baseline to post intervention of increased physical activity is measured by thromboelastography (TEG). TEG is often used to predict bleeding and diagnose various bleeding disorders. Lysis 30% and Lysis 60% are measurements of percent amplitude reduction 30 and 60 minutes after maximum amplitude, respectively, on thromboelastography. Decreased clotting ability (negative value) = better outcome Increased clotting ability (positive value)= worse outcome | From baseline to 6 month | 
| Change in Quality of Life | Change in Quality of Life from baseline to post intervention of increased physical activity assessed by PedsQL instrument. It consists of structured interview with the parents and the child with 23 items divided among 4 sub-scales to assess function in 4 domains: Physical; Emotional; social; and School. Each item is a statement of a problem, which the subject rates in severity from 0-4, indicating a problem never occurs (score of 0) to almost always occurs (score of 4). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50,3=25,4=0, with higher scores indicating better health related QoL. The positive change from baseline to 6 months correspond to better quality of life. | From baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood clot, Venous thromboembolism, Deep Vein Thrombosis, Lower Extremity, Anticoagulation, Physical Activity, Fitbit, Post-thrombotic syndrome, Post-phlebitic syndrome, Thrombosis