Post Thrombotic SyndromePACTNCT03075761
Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)
A study testing Fitbit and 30-minute education session in people with Post Thrombotic Syndrome and Deep Vein Thrombosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Post Thrombotic Syndrome, Deep Vein Thrombosis
- What is being tested?
- Fitbit and 30-minute education session
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2016to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A radiologically confirmed, acute, proximal first lower extremity DVT
- 4 to 8 weeks after starting anticoagulation
- Out-patient ambulatory status
Who cannot join
- Contraindication to increasing activity such as patients with juvenile arthritis, poor balance, congestive heart failure, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity in Children at Risk of Post-thrombotic Sequelae: A Pilot Randomized Controlled Trial
'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.
Read the 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.
- Conditions
- Post Thrombotic Syndrome, Deep Vein Thrombosis
- Being tested
- Fitbit, 30-minute education session
- Keywords
- Venous thromboembolism, Deep Vein Thrombosis, Lower Extremity, Blood clot, Anticoagulation, Physical Activity, Fitbit, Post-thrombotic syndrome, Post-phlebitic syndrome, Thrombosis
- Medical subject headings
- Postthrombotic Syndrome, Venous Thrombosis, Venous Thromboembolism, Thrombosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitDevice
Also called Activity tracker
The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.
30-minute education sessionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: 30-minute education session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Within 24 months of trial initiation
Secondary outcomes (7)
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.
Measured: From baseline to 6 months
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
Measured: From baseline to 6 month
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.
Measured: From baseline to 6 month
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.
Measured: From baseline to 6 month
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.
Measured: From baseline to 6 month
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
Measured: From baseline to 6 month
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.
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start18 Nov 2016
- Primary completion9 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Thrombotic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Scottish Rite Hospital for Children, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ayesha Zia, University of Texas Southwestern Medical Center
- Investigators
- Ayesha Zia, M.D, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075761
- Sponsor's protocol ID
- STU 022016-057
- Other IDs
- 1K23HL132054-01
- Acronym
- PACT
- Status last verified
- Mar 2021
- First submitted
- 20 Apr 2016
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32780844
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Children at Risk of Post-thrombotic Sequelae: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03075761
- Acronym / sponsor ID
- PACT / STU 022016-057
- Conditions
- Post Thrombotic Syndrome, Deep Vein Thrombosis
- Keywords
- Venous thromboembolism, Deep Vein Thrombosis, Lower Extremity, Blood clot, Anticoagulation, Physical Activity, Fitbit, Post-thrombotic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Texas Scottish Rite Hospital for Children, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
'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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Fitbit, Behavioral: 30-minute education sessionParticipants 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. |
| Control | Active comparator | Behavioral: 30-minute education sessionParticipants 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. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- A radiologically confirmed, acute, proximal first lower extremity DVT
- 4 to 8 weeks after starting anticoagulation
- Out-patient ambulatory status
Key exclusion criteria (1 listed)
- Contraindication to increasing activity such as patients with juvenile arthritis, poor balance, congestive heart failure, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitAlso: Activity trackerThe Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen. | Device | Intervention |
| 30-minute education session | Behavioural | Control, Intervention |
Primary outcome
Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline
Time frame: 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
Time frame: 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 )
Time frame: 8 weeks
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)
Time frame: 3 months
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)
Time frame: 6 months
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)
Time frame: 9 months
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
Time frame: Within 24 months of trial initiation
Feasibility criteria is met when assessed to be ≥ 80%. This includes the number of subjects who successfully completed the trial.
7 secondary outcomes
Change in PTS Biomarkers (D-dimer)
Time frame: From baseline to 6 months
Percentage Change From Baseline in FVIII PTS Biomarker
Time frame: From baseline to 6 month
Change in PTS Biomarkers (C-reactive Protein)
Time frame: From baseline to 6 month
Change in PTS Biomarkers (Fibrinolysis - Endogenous Thrombin Potential)
Time frame: From baseline to 6 month
Change in PTS Biomarkers (Fibrinolysis - Thrombin Generation)
Time frame: From baseline to 6 month
Percent Change in Fibrinolysis Biomarker
Time frame: From baseline to 6 month
Change in Quality of Life
Time frame: From baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32780844Hasan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Zia, M.D principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit and 30-minute education session in people with Post Thrombotic Syndrome and Deep Vein Thrombosis, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Measured by Number of Participants Who Meet Study Eligibility Criteria at Baseline (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075761, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.