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

Primary Purpose

Post Thrombotic Syndrome, Deep Vein Thrombosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit
30-minute education session
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Thrombotic Syndrome focused on measuring Venous thromboembolism, Deep Vein Thrombosis, Lower Extremity, Blood clot, Anticoagulation, Physical Activity, Fitbit, Post-thrombotic syndrome, Post-phlebitic syndrome, Thrombosis

Eligibility Criteria

7 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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.
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).
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).
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).
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.

Secondary Outcome Measures

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.
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
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.
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.
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.
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
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.

Full Information

First Posted
April 20, 2016
Last Updated
April 26, 2021
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Texas Scottish Rite Hospital for Children, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03075761
Brief Title
Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)
Acronym
PACT
Official Title
Physical Activity in Children at Risk of Post-thrombotic Sequelae: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 18, 2016 (Actual)
Primary Completion Date
October 9, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Texas Scottish Rite Hospital for Children, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Thrombotic Syndrome, Deep Vein Thrombosis
Keywords
Venous thromboembolism, Deep Vein Thrombosis, Lower Extremity, Blood clot, Anticoagulation, Physical Activity, Fitbit, Post-thrombotic syndrome, Post-phlebitic syndrome, Thrombosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fitbit
Other Intervention Name(s)
Activity tracker
Intervention Description
The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.
Intervention Type
Behavioral
Intervention Name(s)
30-minute education session
Primary Outcome Measure Information:
Title
Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline
Description
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
Time Frame
Baseline
Title
Number of Screened Subjects Who Provided Consent at Baseline
Description
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
Time Frame
Baseline
Title
Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm )
Description
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.
Time Frame
8 weeks
Title
Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only)
Description
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).
Time Frame
3 months
Title
Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only)
Description
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).
Time Frame
6 months
Title
Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only)
Description
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).
Time Frame
9 months
Title
Proportion of Subjects Who Complete Post-randomization
Description
Feasibility criteria is met when assessed to be ≥ 80%. This includes the number of subjects who successfully completed the trial.
Time Frame
Within 24 months of trial initiation
Secondary Outcome Measure Information:
Title
Change in PTS Biomarkers (D-dimer)
Description
Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by coagulation activation marker D-dimer.
Time Frame
From baseline to 6 months
Title
Percentage Change From Baseline in FVIII PTS Biomarker
Description
Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by the coagulation activation marker FVIII
Time Frame
From baseline to 6 month
Title
Change in PTS Biomarkers (C-reactive Protein)
Description
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.
Time Frame
From baseline to 6 month
Title
Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential)
Description
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.
Time Frame
From baseline to 6 month
Title
Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation)
Description
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.
Time Frame
From baseline to 6 month
Title
Percent Change in Fibrinolysis Biomarker
Description
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
Time Frame
From baseline to 6 month
Title
Change in Quality of Life
Description
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.
Time Frame
From baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Zia, M.D
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32780844
Citation
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.
Results Reference
derived

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

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