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

• ClinicalTrials.gov Identifier: NCT03075761
• Recruitment Status: Completed
• First Posted: March 9, 2017
• Last Update Posted: January 7, 2020
• Sponsor: University of Texas Southwestern Medical Center
• 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

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 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 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Texas

Children's Medical Center

Dallas, Texas, United States, 75235

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

More Information

• Responsible Party: Ayesha Zia, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT03075761
• Other Study ID Numbers: STU 022016-057; 1K23HL132054-01 ( U.S. NIH Grant/Contract )
• First Posted: March 9, 2017
• Last Update Posted: January 7, 2020
• Last Verified: January 2020

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:

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