Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome (SEvERe-PTS)

September 11, 2023 updated by: Guy's and St Thomas' NHS Foundation Trust

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • St. Thomas' Hospital, Guy's and St. Thomas' NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Stephen A Black, FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smartphone-based exercise arm
Eight to twelve week smartphone delivered exercise programme
Behavioral: exercise
cardiovascular and lower limb strengthening exercise programme
Other Names:
  • remote exercise programme
  • smartphone-based exercise programme
Active Comparator: Stenting Arm
Deep venous stenting as standard of care
Procedure: Deep venous stenting
Planned surgical intervention
Other Names:
  • Endovascular Stent reconstruction of Deep Vein
No Intervention: Healthy Volunteers
Healthy Volunteers for baseline testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Villalta score.
Time Frame: 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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2 max - maximal oxygen consumption
Time Frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
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
Time Frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
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 Frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
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
Time Frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
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
Time Frame: 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
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
deep venous flow velocity
Time Frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
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.
Maximal calf isometric contract strength as measured by isometric dynamometry.
Time Frame: 1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

Veryan Medical Ltd.

Investigators

  • Principal Investigator: Stephen A Black, FRCS, St Thomas' Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 315612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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