Progressive Gait Training After First-time Deep Venous Thrombosis: Clinical Effectiveness and Involved Mecanisms (The DVT-Cph RCT)

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 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 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 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 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

The Villalta-score consists of five patient-related venous symptoms and six clinician-rated physical signs. Each of the 11 items is graded on a scale from 0 (not present) to 3 points (severe) rendering a maximum total score of 33 points (Lee A et.al., 2021). The points are summed and results in a total score. Subject are classified as having developed PTS if the score is ≥ 5 points or if a venous ulcer is present, in the leg ipsilateral to the initial DVT at a single assessment (Kahn SR et al., 2014, Kahn SR et al., 2009) , either at 90 days (+/-30 days), 12 months (+/- 30 days) or 24 months (+/- 30 days) at the follow-up visits. The severity of PTS can further be categorized as mild (Villalta score 5-9), moderate (score between 10-14), or severe PTS/venous ulcer (score ≥ 15).

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