Physical Activity in Children at Risk of Post-thrombotic Syndrome: A Pilot Randomized Controlled Trial
Study ID: STU 022016-057
The study design is a pilot randomized control trial to test the feasibility of the proposed activity tracker to increase activity in children post DVT, against standard practice, which consists of providing education about PTS and instruction to 'be active'. all newly diagnosed patients with first, lower extremity DVT diagnosed at Children's Health System of Texas (CHST) or referred to the Hemostasis Thrombosis Center (HTC) at CHST who have completed 10-12 weeks of anticoagulation therapy, will be approached for recruitment. The parents/legal guardians will be given an explanation about the study and informed consent and/or assent will be obtained. History and Physical exam, blood labs, information on anticoagulation therapy, radiological images and assessment of Post-thrombotic syndrome (PTS) will be collected as standard of care during the initial visit. Participants will be randomized to either the intervention or standard of care arm. The intervention arm will wear a Fitbit for a 16-week period in addition to a standardized 15-20-minute education session on PTS and the benefits of increased activity. Subjects will receive a standardized 30-minute education session, which in addition to information on post-thrombotic syndrome, will also include general information on venous thromboembolism,treatment principles including education about foods (for subjects on Warfarin) and activities to avoid while on anticoagulation. as the principle muscles affected by post-thrombotic syndromes are the lower limb muscles, for subjects randomized to the intervention arm, the Pi has opted to use a walking-jogging program to capture steps/day by the Fitbit. Steps taken, distance travelled, calories burned and the heart rate with activity will be recorded from the Fitbit. Walking and jogging are both allowed and considered safe while on anticoagulation. as is the case in routine practice, subjects will be asked strictly not to participate in contact sports in order to meet their target steps per day. The SoC arm will be asked to record their physical activity in an activity log. Both arms will receive monthly follow-up calls and be asked to maintain medication (subjects only on Rivaroxaban or Xarelto) and elastic compression stocking (eCS) logs. other study assessments include biomarker testing and the PedsQL completed at every visit.
1. Age 7-21 years 2. A radiologically confirmed, acute, proximal (iliofemoral and femoropoliteal) first lower extremity DVT 3. 12 weeks (+or - 2 weeks) after starting anticoagulation 4. Out-patient ambulatory status