Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome
NCT05744843 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2023-09-13
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.
Conditions
- Post Thrombotic Syndrome
Interventions
- BEHAVIORAL
-
exercise
cardiovascular and lower limb strengthening exercise programme
- PROCEDURE
-
Deep venous stenting
Planned surgical intervention
Sponsors & Collaborators
-
Guy's and St Thomas' NHS Foundation Trust
lead OTHER
Principal Investigators
-
Stephen A Black, FRCS · St Thomas' Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-09-05
- Primary Completion
- 2025-10-31
- Completion
- 2026-04-30
Countries
- United Kingdom
Study Locations
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