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

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ClinicalTrials.gov Identifier: NCT03075761
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : June 6, 2018
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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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 Syndrome: A Pilot Randomized Controlled Trial
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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. Proportion of screened patients who meet eligibility criteria [ Time Frame: Within 9 months ]
    Feasibility criteria met when assessed to be ≥ 30%

  2. Proportion of eligible patients who provide consent [ Time Frame: Within 9 months ]
    Feasibility criteria met when assessed to be ≥ 30%

  3. Level of adherence in the FitBit arm [ Time Frame: Within 6 months of randomization ]
    Feasibility criteria met when assessed to be ≥ 60%

  4. Proportion of subjects who complete the trial post randomization [ Time Frame: Within 6 months of randomization ]
    Feasibility criteria met when assessed to be ≥ 80%


Secondary Outcome Measures :
  1. Change in PTS biomarkers pre and post intervention of increased physical activity as measured by markers of coagulation activation, inflammation and fibrinolysis [ Time Frame: Within 6 months of randomization ]
    Markers of coagulation activation as assessed by D-dimer, FVIII; inflammation as assessed by C-reactive protein and markers of fibrinolysis as assessed by PAI-1, in addition to global coagulation assays, namely thrombin generation and TEG-fibrinolysis

  2. Change in Quality of Life [ Time Frame: Within 6 months of randomization ]
    As assessed by PedsQL instrument


Other Outcome Measures:
  1. Change in physical activity scores [ Time Frame: Within 6 months of randomization ]
    As determined by Gordon Questionnaire

  2. Elastic Compression Stocking (ECS) use assessed by ECS logs [ Time Frame: Within 6 months of randomization ]
    ECS use will be assessed by ECS log/diary documenting dedicated (use for at least 6 days/week), moderate (use for 4-5 days/week) or poor use (<4 days/week)



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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


Contacts
Contact: Kendra Malone, MPH 214-456-3359 kendra.malone@childrens.com
Contact: Anna Winborn, CCRC 214-456-8185 anna.winborn@childrens.com

Locations
United States, Texas
Children's Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Ayesha Zia, MD       ayesha.zia@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Texas Scottish Rite Hospital for Children
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Ayesha Zia, M.D University of Texas Southwestern Medical Center

Responsible Party: Ayesha Zia, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03075761     History of Changes
Other Study ID Numbers: STU 022016-057
1K23HL132054-01 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Syndrome
Thrombosis
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases