RECRUITINGINTERVENTIONAL

Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome

Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome Pilot Study and Randomised Control Trial

About This Trial

The goal of this pilot study and randomised control trial is to compare a smartphone-based exercise programme to deep venous stenting in patients with Post Thrombotic Syndrome. The main questions it aims to answer are: * Is exercise as effective as stenting in these patients? * What type of exercise is useful in these patients? * Can exercise be used to improve the results from surgery? Participants will be split into two groups at random. They will complete a smartphone-based exercise programme or have a deep venous stent. They will do the following tests before and after. * Exercise testing * Calf muscle strength and function tests * Ultrasound of the deep veins * Quality of life questionnaires * Clinical assessment of their disease They will be compared to healthy volunteers in the pilot study. Investigators will compare exercise to stenting to see if it improves symptoms in these patients. The pilot study will help decide how many patients are needed and what exercise tests will be used for the Randomised control trial.

Who May Be Eligible (Plain English)

Who May Qualify: • Patients with symptomatic chronic venous outflow obstruction secondary to PTS or other cause affecting the Inferior Vena Cava (IVC) or iliofemoral vein(s) for greater than 12 months duration AND clinical indication for Deep Venous Stenting. Who Should NOT Join This Trial: - Deep Vein Thrombosis or Pulmonary Embolism within the last 12 months - Significant or untreated left sided heart disease - Significant or untreated respiratory disease - Significant renal disease - Significant liver disease - Significant Musculoskeletal or Neurological disease - Active cancer - Life expectancy of less than 2 years or non-ambulatory status - Current or Planned pregnancy within the study period - Any other contraindication to exercise - Any impairment preventing the provision of willing to sign a consent form and compliance with study protocol - Healthy Volunteers in the control group with presence of any arterial or venous disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: • Patients with symptomatic chronic venous outflow obstruction secondary to PTS or other cause affecting the Inferior Vena Cava (IVC) or iliofemoral vein(s) for greater than 12 months duration AND clinical indication for Deep Venous Stenting. Exclusion Criteria: * Deep Vein Thrombosis or Pulmonary Embolism within the last 12 months * Significant or untreated left sided heart disease * Significant or untreated respiratory disease * Significant renal disease * Significant liver disease * Significant Musculoskeletal or Neurological disease * Active cancer * Life expectancy of less than 2 years or non-ambulatory status * Current or Planned pregnancy within the study period * Any other contraindication to exercise * Any impairment preventing the provision of informed consent and compliance with study protocol * Healthy Volunteers in the control group with presence of any arterial or venous disease

Treatments Being Tested

BEHAVIORAL

exercise

cardiovascular and lower limb strengthening exercise programme

PROCEDURE

Deep venous stenting

Planned surgical intervention

Locations (1)

St. Thomas' Hospital, Guy's and St. Thomas' NHS Foundation Trust

London, United Kingdom