Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05744843
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2023-01-25
Brief Title:
Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome Pilot Study and Randomised Control Trial
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEvERe-PTS
Brief 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
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
Detailed Description:
This is a non-commercial pilot study leading to a randomised control trial
Primary objective
1 To evaluate smartphone-based exercise as an alternative to stenting in patients with IVC and Iliofemoral vein outflow obstruction secondary to Post Thrombotic Syndrome PTS
Secondary objectives
1 To characterise symptomatology and response to different exercise modalities in patients with chronic venous insufficiency
2 Evaluate exercise physiology in patients with chronic venous insufficiency before and after a supervised exercise programme
3 To explore the use of available technologies such as smart phone applications and wearable devices to deliver a remotely monitored exercise programme
4 To establish a method of assessment of flow inflow and collateral flow in patients with symptomatic venous obstruction
5 To understand the impact of stent shape and compression on venous flow and the subsequent patient outcomes
6 To set criteria for the stratification of patient treatment based upon objective and quantitative measures in patients with venous claudication
Participants will be recruited to the following three groups
Group 1 Patients with PTS that will undergo remotely supervised exercise Group 2 Patients with PTS that will undergo stenting Group 3 Healthy volunteers
All participants will undergo series of exercise tests and imaging assessments Participants in group 1 will have these tests repeated at the end of the exercise programme and group 2 when they attend for their six to eight week follow up visit Participants in group 1 will be able to re-join the waiting list for stenting on the condition that they have agreement from their named consultant Investigators anticipate all study activities to be completed before group 1 participants would have received a date for stenting as current waiting times for stenting is in excess of 18 months
Patients from both groups 1 and 2 will be loaned an activity tracker FitBit to wear Group 1 will be asked to wear the tracker from day 1 of the exercise programme group 2 will be asked to wear the tracker from the first post operative day Both groups will wear the tracker until the follow up visit This will allow measurement of general activity in both groups and allow for monitoring of compliance with exercise in group 1
Primary objective
1 To evaluate smartphone-based exercise as an alternative to stenting in patients with IVC and Iliofemoral vein outflow obstruction secondary to Post Thrombotic Syndrome PTS
Secondary objectives
1 To characterise symptomatology and response to different exercise modalities in patients with chronic venous insufficiency
2 Evaluate exercise physiology in patients with chronic venous insufficiency before and after a supervised exercise programme
3 To explore the use of available technologies such as smart phone applications and wearable devices to deliver a remotely monitored exercise programme
4 To establish a method of assessment of flow inflow and collateral flow in patients with symptomatic venous obstruction
5 To understand the impact of stent shape and compression on venous flow and the subsequent patient outcomes
6 To set criteria for the stratification of patient treatment based upon objective and quantitative measures in patients with venous claudication
Participants will be recruited to the following three groups
Group 1 Patients with PTS that will undergo remotely supervised exercise Group 2 Patients with PTS that will undergo stenting Group 3 Healthy volunteers
All participants will undergo series of exercise tests and imaging assessments Participants in group 1 will have these tests repeated at the end of the exercise programme and group 2 when they attend for their six to eight week follow up visit Participants in group 1 will be able to re-join the waiting list for stenting on the condition that they have agreement from their named consultant Investigators anticipate all study activities to be completed before group 1 participants would have received a date for stenting as current waiting times for stenting is in excess of 18 months
Patients from both groups 1 and 2 will be loaned an activity tracker FitBit to wear Group 1 will be asked to wear the tracker from day 1 of the exercise programme group 2 will be asked to wear the tracker from the first post operative day Both groups will wear the tracker until the follow up visit This will allow measurement of general activity in both groups and allow for monitoring of compliance with exercise in group 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None