Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT03075761
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2016-04-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054070', 'term': 'Postthrombotic Syndrome'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072936', 'term': 'Fitness Trackers'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000076251', 'term': 'Wearable Electronic Devices'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ayesha.Zia@UTSouthwestern.edu', 'phone': '214-456-7000', 'title': 'Ayesha Zia, MD', 'organization': 'The University of Texas Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From enrollment to end of treatment at 24 months', 'description': 'Adverse events and serious adverse events were not collected as they were not the primary and secondary outcomes of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', '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.\n\nFitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', '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.\n\n30-minute education session', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inpatients and Outpatients With VTE', 'description': 'All Inpatients and outpatients with VTE from following 3 sources:\n\n(1) new patient referrals to the Bleeding Disorders and Thrombosis outpatient clinic, (2) inpatient admissions to the hematology service, and (3) inpatient consultations for VTE that were not on primary hematology service.'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Feasibility criteria for rate of study eligibility met when assessed to be ≥ 30%\n\nINCLUSION CRITERIA:\n\n1.) 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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Screened Subjects Who Provided Consent at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eligible Subjects Who Consented', 'description': 'Screened subjects who met the eligibility criteria are included in this cohort.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Feasibility criteria for rate of consent was assessed to be ≥ 30% at baseline\n\nINCLUSION CRITERIA:\n\n1.) 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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this specific outcome, we only assess the screened subjects who met the eligibility criteria are included in this cohort.'}, {'type': 'PRIMARY', 'title': 'Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "FitBit Group's Adherence to Physical Activity", 'description': 'Targeted activity is defined as walking-jogging program to capture steps/day by the Fitbit during Active phase. If preferred or already involved, participants may perform strenuous muscle-strengthening or bone-strengthening exercises (eg, lifting weights, jumping rope, dancing, or team sports) to replace the walking-jogging program as long as the target goal for physical activity was met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', '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.', 'unitOfMeasure': 'number of participants', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Standard of Care Group's Adherence to Physical Activity", 'description': 'Proportion of participants who completed and submitted physical activity questionnaires.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Standard of Care Group's Adherence to Physical Activity", 'description': 'Proportion of participants who completed and submitted physical activity questionnaires.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who submitted the questionnaire were included.'}, {'type': 'PRIMARY', 'title': 'Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Standard of Care Group's Adherence to Physical Activity", 'description': 'Proportion of participants who completed and submitted physical activity questionnaires.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months', '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who submitted the questionnaire were included.'}, {'type': 'PRIMARY', 'title': 'Proportion of Subjects Who Complete Post-randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', '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.\n\nFitBit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'OG001', 'title': 'Control', '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.\n\n30-minute education session'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 24 months of trial initiation', 'description': 'Feasibility criteria is met when assessed to be ≥ 80%. This includes the number of subjects who successfully completed the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm.'}, {'type': 'SECONDARY', 'title': 'Change in PTS Biomarkers (D-dimer)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', '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.\n\nFitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'OG001', 'title': 'Control', '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.\n\n30-minute education session'}], 'classes': [{'categories': [{'measurements': [{'value': '-4675', 'spread': '5633', 'groupId': 'OG000'}, {'value': '-6241', 'spread': '6780', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 6 months', 'description': 'Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by coagulation activation marker D-dimer.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm.'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in FVIII PTS Biomarker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', '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.\n\nFitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'OG001', 'title': 'Control', '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.\n\n30-minute education session'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.6', 'spread': '92', 'groupId': 'OG000'}, {'value': '-50.4', 'spread': '82.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 6 month', 'description': 'Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by the coagulation activation marker FVIII', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in PTS Biomarkers (C-reactive Protein)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', '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.\n\nFitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'OG001', 'title': 'Control', '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.\n\n30-minute education session'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 6 month', '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.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm.'}, {'type': 'SECONDARY', 'title': 'Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', '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.\n\nFitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'OG001', 'title': 'Control', '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.\n\n30-minute education session'}], 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': '223', 'groupId': 'OG000'}, {'value': '-60.1', 'spread': '148', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 6 month', '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.', 'unitOfMeasure': 'nM*min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm.'}, {'type': 'SECONDARY', 'title': 'Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', '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.\n\nFitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'OG001', 'title': 'Control', '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.\n\n30-minute education session'}], 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '164', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '28.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 6 month', '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.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Fibrinolysis Biomarker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', '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.\n\nFitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'OG001', 'title': 'Control', '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.\n\n30-minute education session'}], 'classes': [{'title': 'Lysis 30, % (percent amplitude change 30 minutes after maximum amplitude)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Lysis 60, % (percent amplitude change 60 minutes after maximum amplitude)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 6 month', '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.\n\nLysis 30% and Lysis 60% are measurements of percent amplitude reduction 30 and 60 minutes after maximum amplitude, respectively, on thromboelastography.\n\nDecreased clotting ability (negative value) = better outcome Increased clotting ability (positive value)= worse outcome', 'unitOfMeasure': 'percent amplitude change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', '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.\n\nFitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'OG001', 'title': 'Control', '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.\n\n30-minute education session'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '24.5', 'spread': '14.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 6 months', '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.\n\nThe positive change from baseline to 6 months correspond to better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For this specific outcome, we only assess the 11 subjects in the intervention arm and 12 subjects in the control arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', '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.\n\nFitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'FG001', 'title': 'Control', '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.\n\n30-minute education session'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': '111 patients were screened, of whom 40 (36%) met study eligibility criteria. Of these, 23 (57.5%) consented to participate (11 randomized to physical activity arm and 12 to education or standard care arm)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', '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.\n\nFitbit: The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.\n\n30-minute education session'}, {'id': 'BG001', 'title': 'Control', '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.\n\n30-minute education session'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.18', 'spread': '2.04', 'groupId': 'BG000'}, {'value': '14.25', 'spread': '2.56', 'groupId': 'BG001'}, {'value': '14.70', 'spread': '2.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.83', 'spread': '12.34', 'groupId': 'BG000'}, {'value': '26.86', 'spread': '5.58', 'groupId': 'BG001'}, {'value': '28.28', 'spread': '9.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'OW/obese', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were categorized to have normal weight if their BMI was between 5th and 85th, overweight for BMI between \\>85th-95th, and obese if BMI was ≥ 95th percentile for age and sex (Reference: Severe obesity in children and adolescents: identification, associated health risks, and treatment approaches: a scientific statement from the American Heart Association)', 'unitOfMeasure': 'Participants'}, {'title': 'Clot burden at diagnosis occlusive', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Clot burden was defined as completely occlusive thrombus in at least one vein segment at VTE diagnosis.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-02', 'size': 1560711, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-05T16:29', 'hasProtocol': True}, {'date': '2018-06-05', 'size': 184488, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-05T16:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2016-04-20', 'resultsFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2017-03-03', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-26', 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline', 'timeFrame': 'Baseline', 'description': 'Feasibility criteria for rate of study eligibility met when assessed to be ≥ 30%\n\nINCLUSION CRITERIA:\n\n1.) 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'}, {'measure': 'Number of Screened Subjects Who Provided Consent at Baseline', 'timeFrame': 'Baseline', 'description': 'Feasibility criteria for rate of consent was assessed to be ≥ 30% at baseline\n\nINCLUSION CRITERIA:\n\n1.) 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'}, {'measure': 'Mean Number of Participants Who Adhered to the Assigned Physical Activity During 8-week Period (Intervention Arm -FitBit Arm )', 'timeFrame': '8 weeks', '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.'}, {'measure': 'Mean Physical Activity Questionnaire Score at 3 Months (Standard of Care Arm Only)', 'timeFrame': '3 months', '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).'}, {'measure': 'Mean Physical Activity Questionnaire Score at 6 Months (Standard of Care Arm Only)', 'timeFrame': '6 months', '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).'}, {'measure': 'Mean Physical Activity Questionnaire Score at 9 Months (Standard of Care Arm Only)', 'timeFrame': '9 months', '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).'}, {'measure': 'Proportion of Subjects Who Complete Post-randomization', 'timeFrame': 'Within 24 months of trial initiation', 'description': 'Feasibility criteria is met when assessed to be ≥ 80%. This includes the number of subjects who successfully completed the trial.'}], 'secondaryOutcomes': [{'measure': 'Change in PTS Biomarkers (D-dimer)', 'timeFrame': 'From baseline to 6 months', 'description': 'Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by coagulation activation marker D-dimer.'}, {'measure': 'Percentage Change From Baseline in FVIII PTS Biomarker', 'timeFrame': 'From baseline to 6 month', 'description': 'Change in PTS biomarkers from baseline to post intervention of increased physical activity measured by the coagulation activation marker FVIII'}, {'measure': 'Change in PTS Biomarkers (C-reactive Protein)', 'timeFrame': 'From baseline to 6 month', '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.'}, {'measure': 'Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential)', 'timeFrame': 'From baseline to 6 month', '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.'}, {'measure': 'Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation)', 'timeFrame': 'From baseline to 6 month', '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.'}, {'measure': 'Percent Change in Fibrinolysis Biomarker', 'timeFrame': 'From baseline to 6 month', '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.\n\nLysis 30% and Lysis 60% are measurements of percent amplitude reduction 30 and 60 minutes after maximum amplitude, respectively, on thromboelastography.\n\nDecreased clotting ability (negative value) = better outcome Increased clotting ability (positive value)= worse outcome'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'From baseline to 6 months', '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.\n\nThe positive change from baseline to 6 months correspond to better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Venous thromboembolism', 'Deep Vein Thrombosis', 'Lower Extremity', 'Blood clot', 'Anticoagulation', 'Physical Activity', 'Fitbit', 'Post-thrombotic syndrome', 'Post-phlebitic syndrome', 'Thrombosis'], 'conditions': ['Post Thrombotic Syndrome', 'Deep Vein Thrombosis']}, 'referencesModule': {'references': [{'pmid': '32780844', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '\'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.', 'detailedDescription': '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).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A radiologically confirmed, acute, proximal first lower extremity DVT\n* 4 to 8 weeks after starting anticoagulation\n* Out-patient ambulatory status\n\nExclusion Criteria:\n\n* Contraindication to increasing activity such as patients with juvenile arthritis, poor balance, congestive heart failure, etc.'}, 'identificationModule': {'nctId': 'NCT03075761', 'acronym': 'PACT', 'briefTitle': 'Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Physical Activity in Children at Risk of Post-thrombotic Sequelae: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STU 022016-057'}, 'secondaryIdInfos': [{'id': '1K23HL132054-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23HL132054-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', '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.', 'interventionNames': ['Device: Fitbit', 'Behavioral: 30-minute education session']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', '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.', 'interventionNames': ['Behavioral: 30-minute education session']}], 'interventions': [{'name': 'Fitbit', 'type': 'DEVICE', 'otherNames': ['Activity tracker'], 'description': 'The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.', 'armGroupLabels': ['Intervention']}, {'name': '30-minute education session', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Ayesha Zia, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Texas Scottish Rite Hospital for Children', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Ayesha Zia', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}