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

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

'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.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis; Post Thrombotic Syndrome
• Intervention / Treatment: Device: Fitbit; Behavioral: 30-minute education session

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
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Texas Scottish Rite Hospital for Children
• Investigators: Principal Investigator: Ayesha Zia, M.D, University of Texas Southwestern Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2016
• Primary Completion (Actual): October 9, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: April 20, 2016
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Physical Activity; Anticoagulation; Deep Vein Thrombosis; Thrombosis; Venous thromboembolism; Lower Extremity; Fitbit; Post-thrombotic syndrome; Blood clot; Post-phlebitic syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Syndrome; Thrombosis; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: STU 022016-057; 1K23HL132054-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No