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

NCT03075761 | Completed Results

• 2 other identifiers: STU 022016-0571K23HL132054-01
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• Change in PTS Biomarkers (D-dimer)

  From baseline to 6 months

• Percentage Change From Baseline in FVIII PTS Biomarker

  From baseline to 6 month

• Change in PTS Biomarkers (C-reactive Protein)

  From baseline to 6 month

• Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential)

  From baseline to 6 month

• Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation)

  From baseline to 6 month

Study Arms (2)

Intervention

EXPERIMENTAL

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; Behavioral: 30-minute education session

Control

ACTIVE COMPARATOR

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

Interventions

Fitbit DEVICE

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

Also known as: Activity tracker

Intervention

30-minute education session BEHAVIORAL

Control; Intervention

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A radiologically confirmed, acute, proximal first lower extremity DVT
• to 8 weeks after starting anticoagulation
• Out-patient ambulatory status

You may not qualify if:

• Contraindication to increasing activity such as patients with juvenile arthritis, poor balance, congestive heart failure, etc.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Texas Scottish Rite Hospital for Children: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 32780844 DERIVED

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis; Venous Thromboembolism; Thrombosis; Motor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Thromboembolism; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Results Point of Contact

• Title: Ayesha Zia, MD
• Organization: The University of Texas Southwestern Medical Center

Ayesha.Zia@UTSouthwestern.edu

214-456-7000

Study Officials

• Ayesha Zia, M.D

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: March 9, 2017
• Study Start: November 18, 2016
• Primary Completion: October 9, 2019
• Study Completion: October 10, 2019
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)