Deep Vein Thrombosis (DVT)
Conditions
Keywords
Physical activity
Brief summary
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).
Detailed description
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.
Interventions
OTHERProgressive gait training
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.
OTHERStandard Care (in control arm)
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.
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or above * First time lower extremity DVT * Hospitalized at the Emergency Department * Can cooperate cognitively and physically (patient reported)
Exclusion criteria
* Patients without a Danish social security number * Terminal patients * Patients who do not understand or speak Danish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | Change from baseline to 3 (end of intervention), 12, and 24 months after discharge | 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 | Recurrent weekly outcome from baseline to 3 months after discharge (end of intervention) | 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 | Change from baseline to 3 (end of intervention), 12, and 24 months after discharge | 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 |
| 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) | 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). |
| Number of DVT related hospital contacts | From baseline to 3, 12, and 24 months after discharge | — |
Countries
Denmark
Contacts
CONTACTMette Merete Pedersen, Ph.D.
CONTACTOve Andersen, M.D., Ph.D.
PRINCIPAL_INVESTIGATORHelle Juul-Larsen, Ph.D.
Hvidovre University Hospital
PRINCIPAL_INVESTIGATORMette Merete Pedersen, Ph.D.
Hvidovre University Hospital
PRINCIPAL_INVESTIGATORIzzet Altinas, M.D.
Hvidovre University Hospital
Outcome results
None listed