An interventional study of Progressive gait training and Standard Care (in control arm) in Deep Vein Thrombosis (DVT), sponsored by Hvidovre University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Treatment
The DVT-Cph RCT aims to investigate:
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.
785 studies on the registry are indexed under Venous Thrombosis; 110 are open to participants now.
This study's planned enrollment of 152 is close to the median of 152 across 477 interventional studies indexed under Venous Thrombosis.
Browse Venous Thrombosis studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Other: Progressive gait training
Other: Standard Care (in control arm)
The 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 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).
Time frame: Change from baseline to 3 months after discharge (end of intervention)
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).
Time frame: Change from baseline to 12 and 24 months after discharge
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).
Time frame: Change from baseline to 3 (end of intervention), 12, and 24 months after discharge
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
Time frame: Recurrent weekly outcome from baseline to 3 months after discharge (end of intervention)
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
Time frame: 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
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).
Time frame: Change from baseline to 3 (end of intervention), 12, and 24 months after discharge (end of intervention)
Number of DVT related hospital contacts
Time frame: From baseline to 3, 12, and 24 months after discharge
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
Time frame: Change from baseline to 3, 12, and 24 months after discharge
Plan to share: No — Public deposition of raw data points is not possible due to Denmarks national legislation (Data Protection Act § 10 and Data Disclosure Proclamation Act) which outline that we can only transfer pseudonymized data to the Journal after the Data Protection Authorities approval (Data Protection Act § 10, section 3, nr. 3.). Reviewers and others may obtain access to the data by request, and after the Danish Data Protection Agency has approved of the data transfer from the Capital Region to the Journal. If others are to gain access to the pseudonymized data, the Journal shall ensure that is an adequate legal basis to share the Capital Regions data and ensure that the data is only being processed for scientific research purposes.
Started Nov 2025 (actual). Primary completion is estimated for Apr 2028, 28 months after the start.
Of 99 non-industry interventional studies with no phase under Venous Thrombosis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 57. This study's planned 28 months is below that.
Counting every sponsor, half of 117 studies reached it within 34 months; a quarter within 13 and three quarters within 56.
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