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

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis; Post Thrombotic Syndrome
• Interventions: Device: Fitbit; Behavioral: 30-minute education session

• Registration Number: NCT03075761
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2016-04-20
• Study Start: 2016-11-18
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Primary Completion: 2019-10-09
• Study Completion: 2019-10-10
• Status Verified: 2021-03
• Results First Submitted: 2021-03-08
• Results First Submitted QC: 2021-04-26
• Last Update Submitted: 2021-04-26
• Results First Posted: 2021-05-18
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

• A radiologically confirmed, acute, proximal first lower extremity DVT
• 4 to 8 weeks after starting anticoagulation
• Out-patient ambulatory status

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Exclusion Criteria

• Contraindication to increasing activity such as patients with juvenile arthritis, poor balance, congestive heart failure, etc.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Fitbit	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.
Intervention	30-minute education session	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.
Control	30-minute education session	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Complete Post-randomization	Within 24 months of trial initiation	Feasibility criteria is met when assessed to be ≥ 80%. This includes the number of subjects who successfully completed the trial.
Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline	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
Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only)	6 months	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).
Number of Screened Subjects Who Provided Consent at Baseline	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
Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only)	3 months	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).
Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm )	8 weeks	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.
Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only)	9 months	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).

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in FVIII PTS Biomarker	From baseline to 6 month	Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by the coagulation activation marker FVIII
Change in PTS Biomarkers (D-dimer)	From baseline to 6 months	Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by coagulation activation marker D-dimer.
Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential)	From baseline to 6 month	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.
Change in PTS Biomarkers (C-reactive Protein)	From baseline to 6 month	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.
Change in Quality of Life	From baseline to 6 months	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.
Percent Change in Fibrinolysis Biomarker	From baseline to 6 month	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
Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation)	From baseline to 6 month	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.

Trial Locations

Locations (1)

Children's Medical Center; 🇺🇸 Dallas, Texas, United States