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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:
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.
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone-based exercise arm | Experimental | Eight to twelve week smartphone delivered exercise programme |
|
| Stenting Arm | Active Comparator | Deep venous stenting as standard of care |
|
| Healthy Volunteers | No Intervention | Healthy Volunteers for baseline testing |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise | Behavioral | cardiovascular and lower limb strengthening exercise programme |
|
| Measure | Description | Time Frame |
|---|---|---|
| Villalta score. | 0-30, >5 diagnostic of post thrombotic disease. 5-9 is mild disease, 9-4 moderate and >15 Severe. (15 automatically added in the presence of a venous leg ulcer). Change in Villalta score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VO2 max - maximal oxygen consumption | change in peak VO2 max on cardiopulmonary exercise testing. Increased value indicates improvement, decreased value indicates deterioration | 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. |
| Six minute walk test |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal calf isometric contract strength as measured by isometric dynamometry. | Change in calf muscle maximal force output, greater output indicates improvement | 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. |
| deep venous flow velocity |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ehsanul K Choudhury, MRCS | Contact | +44 20 7188 7188 | 53821 | ehsanul.choudhury@gstt.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Stephen A Black, FRCS | St Thomas' Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Thomas' Hospital, Guy's and St. Thomas' NHS Foundation Trust | Recruiting | London | SE1 7EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39968829 | Derived | Flumignan RL, Nakano LC, Flumignan CD, Baptista-Silva JC. Angioplasty or stenting for deep venous thrombosis. Cochrane Database Syst Rev. 2025 Feb 19;2(2):CD011468. doi: 10.1002/14651858.CD011468.pub2. |
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| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Deep venous stenting | Procedure | Planned surgical intervention |
|
|
change in six minute walk test. Increased distance indicates improvement, decreased distance indicates deterioration. |
| 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. |
| Incline walk test | Time to onset of symptoms and total incline and speed achieved. Longer time to onset, steeper incline achieved and faster speed acheived indicate improvement. | 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. |
| Calf ejection fraction | change in calf ejection fraction by plethysmography | 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. |
| Venous Insufficiency Epidemiological and Economic Study quality of life and symptoms (VEINES-QoL/Sym) - disease specific quality of life instrument for Chronic Venous Disorders of the Leg | Change in VEINES-QoL/Sym score - higher value indicates better outcome | 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 |
changes in ultrasound assessed venous flow |
| 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study. |
| D002318 |
| Cardiovascular Diseases |
| D014689 | Venous Insufficiency |
| D001519 | Behavior |