Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome (NCT05744843) | Clinical Trial Compass
UnknownNot Applicable
Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome
United Kingdom54 participantsStarted 2023-09-05
Plain-language summary
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 can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Villalta score.
Timeframe: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. 3) Study completion, 6 months