Progressive Gait Training After First-time Deep Venous Thrombosis: Clinical Effectiveness and Involved Mecanisms (The DVT-Cph RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire
研究概览
简要总结
The DVT-Cph RCT aims to investigate:
- if progressive gait training in combination with standard care is superior to standard care on quality of life in patients with first time lower extremity deep venous thrombosis (clinical effectiveness part).
- the association between progressive gait training and disease progression, late complications such as post throbotic syndrome, and severity of venous thromboembolism conditions in patients with first time lower extremity deep venous thrombosis (mechanistic part).
详细描述
The DVT-Cph RCT will be qualified by a preceeding feasibility trial (NCT05761119) that aims to investigate: (1) the feasibility of the intervention and trial procedures using quantitative outcomes, and (2) patient experiences with and attititudes towards the intervention using qualitative interviews.
Simultaneously with the RCT, a prospective cohort study (The DVT-Cph cohort study; NCT05789108) will investigate and characterize acutely admitted patients with deep venous thrombosis via inflammatory, anti-inflammatory, immunological and ageing biomarkers to gain a better understanding of options about prevention and treatment of long-term complications. Patients enrolled in the feasibility trial as well as in the DVT-Cph RCT can also enroll in the DVT-Cph cohort study to utilize study synergy and enhance research information gain.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or above
- •First time lower extremity DVT
- •Hospitalized at the Emergency Department
- •Can cooperate cognitively and physically (patient reported)
排除标准
- •Patients without a Danish social security number
- •Terminal patients
- •Patients who do not understand or speak Danish
研究组 & 干预措施
Intervention
干预措施: Progressive gait training (Other)
Control
干预措施: Standard Care (in control arm) (Other)
结局指标
主要结局
The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire
时间窗: Change from baseline to 3 months after discharge (end of intervention)
The VEINES-Qol is a validated disease-specific questionnaire for measuring quality of life among patients with a venous disease (Lamping D et al., 2003).
次要结局
- The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire(Change from baseline to 12 and 24 months after discharge)
- Health status measured by the EuroQol instrument (EQ-5D-5L)(Change from baseline to 3 (end of intervention), 12, and 24 months after discharge)
- Pain measured by the Visual Analogue Scale(Recurrent weekly outcome from baseline to 3 months after discharge (end of intervention))
- Oedema(Change from baseline to 3 (end of intervention), 12, and 24 months after discharge)
- Development of Post Thrombotic Syndrome (PTS) measured by the Villalta-score(Change from baseline to 3 (end of intervention), 12, and 24 months after discharge (end of intervention))
- Number of DVT related hospital contacts(From baseline to 3, 12, and 24 months after discharge)
研究者
Ove Andersen
Professor
Hvidovre University Hospital