The DVT-Cph RCT aims to investigate:
1. 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). 2. 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).
18 years or above
First time lower extremity DVT
Hospitalized at the Emergency Department
Can cooperate cognitively and physically (patient reported)
Patients without a Danish social security number
Terminal patients
Patients who do not understand or speak Danish
Parallel
Progressive gait training
Other interventionThe focus of the intervention is on exercises that can improve venous return, and consists of progressive gait training at moderate and high intensity as well as guidance on progressive gait training. The training program is inspired by the WHO's recommendations for physical activity. The training program consists of a 14-day introductory period based on an initial interview with a physiotherapist, where the aim is to obtain 30 mins/day of gait training at moderate intensity. After 14 days, the patient receives physiotherapist guidance via telephone on progressive gait training and is introduced to the next period of 14 days, where the activity level is maintained, and the goal is to further achive 2 x 20 mins/week of muscle-strengtening activities at moderate or greater intensity. After one and two months of training, the patient will be guided via telephone on maintaining their current level of physical activity or possibly on further progression.
Standard Care (in control arm)
Other interventionStandard care encompasses standard diagnostics with compression ultrasound examination, and a treatment procedure with anticoagulant medication, and compression stockings class III. Standard care also involves visits to the outpatient anticoagulation clinic, where patients with DVT are required to attend treatment sessions within the first 14 days and 90 days after diagnosis. Standard care will serve as a comparator to reflect the current treatment regimen.
The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire
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).
The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire
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).
Health status measured by the EuroQol instrument (EQ-5D-5L)
The EuroQol-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, along with a visual analog scale (EuroQol-VAS). Each dimension includes five response levels, ranging from no problems to extreme problems. The responses are converted into an index value that reflects the individual's health status in comparison to the general population (norm data)(EuroQol Group, 1990; Herdman M et al., 2011 ). EuroQol-VAS measures health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Pain measured by the Visual Analogue Scale
Pain measured by the VAS ranging from "no pain" (score of 0) to "worst imaginable pain" (score of 10). VAS scores are reported weekly by questionnaires sent by email or text message during the intervention as well as during follow up visits. Patients are asked to mark a point on the scale that represents their perception of the pain that they are feeling. Three different variables are collected: I) Current pain, II) lowest perceived pain within the last week and III) highest perceived pain within the last week
Oedema
Oedema on the symptomatic side compared to the healthy side. Oedema is measured by a medical doctor at the calf 10 cm below the tibial tuberosity on both legs
Chronic inflammation
Chronic inflammation will be measured based on the soluble urokinase Plasminogen Activator Receptor (suPAR). suPar will be measured using standard immunoassays. Plasma levels of inflammation biomarkers and anti-inflammation biomarkers will be analysed at Department of Clinical Research, Acute CAG, Copenhagen University Hospital Amager and Hvidovre
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