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

Deep Vein Thrombosis Clinical Trial

— PACT  

Official title:

Physical Activity in Children at Risk of Post-thrombotic Sequelae: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075761
• Other study ID #: STU 022016-057
• Secondary ID: 1K23HL132054-01
• Status: Completed
• Phase: N/A
• Start date: November 18, 2016
• Est. completion date: October 10, 2019

Study information

• Verified date: March 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: October 10, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome
• Thrombosis
• Venous Thrombosis

Intervention

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

Behavioral:
• 30-minute education session

Locations

Country	Name	City	State
United States	Children's Medical Center	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Heart, Lung, and Blood Institute (NHLBI), Texas Scottish Rite Hospital for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	Baseline
Primary	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.	8 weeks
Primary	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).	3 months
Primary	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).	6 months
Primary	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).	9 months
Primary	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.	Within 24 months of trial initiation
Secondary	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.	From baseline to 6 months
Secondary	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	From baseline to 6 month
Secondary	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.	From baseline to 6 month
Secondary	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.	From baseline to 6 month
Secondary	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.	From baseline to 6 month
Secondary	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	From baseline to 6 month
Secondary	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.	From baseline to 6 months