Comparing exercise to stenting for Post Thrombotic Syndrome
Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome Pilot Study and Randomised Control Trial
NA · Guy's and St Thomas' NHS Foundation Trust · NCT05744843
This study is testing whether a smartphone-based exercise program can help people with Post Thrombotic Syndrome just as well as getting a stent.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust (other) |
| Locations | 1 site (London) |
| Trial ID | NCT05744843 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to compare the effectiveness of a smartphone-based exercise program with deep venous stenting in patients suffering from Post Thrombotic Syndrome (PTS). Participants will be randomly assigned to either the exercise group or the stenting group, and their progress will be monitored through various tests, including exercise testing and ultrasound assessments. The study seeks to determine if exercise can serve as a viable alternative to stenting and to explore the impact of different exercise modalities on patient outcomes. Additionally, the study will assess the use of technology in delivering remote exercise programs.
Who should consider this trial
Good fit: Ideal candidates include patients with symptomatic chronic venous outflow obstruction due to Post Thrombotic Syndrome who have a clinical indication for deep venous stenting.
Not a fit: Patients with recent deep vein thrombosis, significant untreated medical conditions, or those who are non-ambulatory may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for patients with Post Thrombotic Syndrome, potentially improving their quality of life.
How similar studies have performed: While the approach of using exercise as a treatment for PTS is innovative, similar studies have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- St. Thomas' Hospital, Guy's and St. Thomas' NHS Foundation Trust — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Stephen A Black, FRCS — St Thomas' Hospital
- Study coordinator: Ehsanul K Choudhury, MRCS
- Email: ehsanul.choudhury@gstt.nhs.uk
- Phone: +44 20 7188 7188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Thrombotic Syndrome, deep venous, exercise, remote, stenting