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

Browse trials for

• Thrombosis 1,506
• Venous Thrombosis 774
• Postthrombotic Syndrome 65
• Postphlebitic Syndrome 47
• Syndrome 9,217

Keywords

• Venous thromboembolism
• Deep Vein Thrombosis
• Lower Extremity
• Blood clot
• Anticoagulation
• Physical Activity
• Fitbit
• Post-thrombotic syndrome
• Post-phlebitic syndrome
• Thrombosis

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 111 is close to the median of 106 across 849 interventional studies indexed under Thrombosis.

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Study arms

• Experimental
  Intervention

  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 · Behavioral: 30-minute education session

• Active comparator
  Control

  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

Interventions

• DeviceFitbit

  The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.

  Also known as: Activity tracker

• Behavioral30-minute education session

Primary outcomes

1. 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

   Time frame: Baseline

2. 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

   Time frame: Baseline

3. 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.

   Time frame: 8 weeks

4. 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).

   Time frame: 3 months

5. 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).

   Time frame: 6 months

6. 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).

   Time frame: 9 months

7. 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.

   Time frame: Within 24 months of trial initiation

Secondary outcomes

1. 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.

   Time frame: From baseline to 6 months

2. 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

   Time frame: From baseline to 6 month

3. 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.

   Time frame: From baseline to 6 month

4. 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.

   Time frame: From baseline to 6 month

5. 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.

   Time frame: From baseline to 6 month

6. 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

   Time frame: From baseline to 6 month

7. 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.

   Time frame: From baseline to 6 months

Baseline characteristics

Publications

• 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. PubMed 32780844 ↗

Study documents

• Protocol and statistical analysis plan · Mar 2, 2021
• Informed consent form · Jun 5, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No