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
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Post Thrombotic Syndrome Deep Vein Thrombosis||Device: Fitbit Behavioral: 30-minute education session||Not Applicable|
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)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- Proportion of screened patients who meet eligibility criteria [ Time Frame: Within 9 months ]Feasibility criteria met when assessed to be ≥ 30%
- Proportion of eligible patients who provide consent [ Time Frame: Within 9 months ]Feasibility criteria met when assessed to be ≥ 30%
- Level of adherence in the FitBit arm [ Time Frame: Within 6 months of randomization ]Feasibility criteria met when assessed to be ≥ 60%
- Proportion of subjects who complete the trial post randomization [ Time Frame: Within 6 months of randomization ]Feasibility criteria met when assessed to be ≥ 80%
- 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
- Change in Quality of Life [ Time Frame: Within 6 months of randomization ]As assessed by PedsQL instrument
- Change in physical activity scores [ Time Frame: Within 6 months of randomization ]As determined by Gordon Questionnaire
- 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)
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
|United States, Texas|
|Children's Medical Center|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Ayesha Zia, M.D||University of Texas Southwestern Medical Center|