Structured Exercise Versus Endovascular Reconstruction in Post Thrombotic Syndrome Pilot Study and Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Villalta score.
研究概览
简要总结
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.
详细描述
This is a non-commercial pilot study, leading to a randomised control trial.
Primary objective:
- 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:
- To characterise symptomatology and response to different exercise modalities in patients with chronic venous insufficiency.
- Evaluate exercise physiology in patients with chronic venous insufficiency before and after a supervised exercise programme.
- To explore the use of available technologies, such as smart phone applications and wearable devices to deliver a remotely monitored exercise programme.
- To establish a method of assessment of flow (inflow and collateral flow) in patients with symptomatic venous obstruction.
- To understand the impact of stent shape and compression on venous flow and the subsequent patient outcomes.
- To set criteria for the stratification of patient treatment based upon objective and quantitative measures in patients with venous claudication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Villalta score.
时间窗: 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
次要结局
- Incline walk test(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(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(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(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)
- VO2 max - maximal oxygen consumption(1) Day 0 - baseline, prior to intervention. 2) up to 2 weeks post intervention, on average week 8-12 of the study.)