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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03075761
Recruitment Status : Completed
First Posted : March 9, 2017
Results First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Collaborators:
Texas Scottish Rite Hospital for Children
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ayesha Zia, 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.

Condition or disease Intervention/treatment Phase
Post Thrombotic Syndrome Deep Vein Thrombosis Device: Fitbit Behavioral: 30-minute education session Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Physical Activity in Children at Risk of Post-thrombotic Sequelae: A Pilot Randomized Controlled Trial
Actual Study Start Date : November 18, 2016
Actual Primary Completion Date : October 9, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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
The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.
Other Name: Activity tracker

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



Primary Outcome Measures :
  1. Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline [ Time Frame: 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


  2. Number of Screened Subjects Who Provided Consent at Baseline [ Time Frame: 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


  3. Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm ) [ Time Frame: 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.

  4. Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only) [ Time Frame: 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).

  5. Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only) [ Time Frame: 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).

  6. Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only) [ Time Frame: 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).

  7. Proportion of Subjects Who Complete Post-randomization [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in PTS Biomarkers (D-dimer) [ Time Frame: 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.

  2. Percentage Change From Baseline in FVIII PTS Biomarker [ Time Frame: 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

  3. Change in PTS Biomarkers (C-reactive Protein) [ Time Frame: 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.

  4. Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential) [ Time Frame: 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.

  5. Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation) [ Time Frame: 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.

  6. Percent Change in Fibrinolysis Biomarker [ Time Frame: 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


  7. Change in Quality of Life [ Time Frame: 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.




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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075761


Locations
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United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Texas Scottish Rite Hospital for Children
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Ayesha Zia, M.D University of Texas Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by Ayesha Zia, University of Texas Southwestern Medical Center:
Informed Consent Form  [PDF] June 5, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ayesha Zia, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03075761    
Other Study ID Numbers: STU 022016-057
1K23HL132054-01 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2017    Key Record Dates
Results First Posted: May 18, 2021
Last Update Posted: May 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayesha Zia, University of Texas Southwestern Medical Center:
Venous thromboembolism
Deep Vein Thrombosis
Lower Extremity
Blood clot
Anticoagulation
Physical Activity
Fitbit
Post-thrombotic syndrome
Post-phlebitic syndrome
Thrombosis
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Syndrome
Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases