Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)
NCT ID: NCT03075761
Last Updated: 2021-05-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
111 participants
INTERVENTIONAL
2016-11-18
2019-10-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post Thrombotic Syndrome Prevention Study
NCT03039517
Novel PET/CT and Treatment Strategies to Reduce PTS Following DVT
NCT03195777
Educating Nurses About Venous Thromboembolism (VTE) Prevention
NCT02301793
Does a Home-based Exercise Programme Affect Physical Capacity and Quality of Life in Patients With Pulmonary Embolism?
NCT02684721
FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease
NCT04583878
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Fitbit
The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.
30-minute education session
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.
30-minute education session
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fitbit
The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.
30-minute education session
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 4 to 8 weeks after starting anticoagulation
* Out-patient ambulatory status
Exclusion Criteria
7 Years
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Texas Scottish Rite Hospital for Children
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ayesha Zia
Assistant Professor of Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ayesha Zia, M.D
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Medical Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STU 022016-057
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.