Clinical trial NCT06909240: Progressive Gait Training After First-time Deep Venous Thrombosis: Clinical Effectiveness and Involved Mecanisms (The DVT-Cph RCT)
Official title: Progressive Gait Training After First-time Deep Venous Thrombosis: Clinical Effectiveness and Involved Mecanisms (The DVT-Cph RCT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Deep Vein Thrombosis (DVT)
Keywords: Physical activity
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire
timeFrame: Change from baseline to 3 months after discharge (end of intervention)
Secondary outcomes:
measure: The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire
timeFrame: Change from baseline to 12 and 24 months after discharge
measure: Health status measured by the EuroQol instrument (EQ-5D-5L)
timeFrame: Change from baseline to 3 (end of intervention), 12, and 24 months after discharge
measure: Pain measured by the Visual Analogue Scale
timeFrame: Recurrent weekly outcome from baseline to 3 months after discharge (end of intervention)
measure: Oedema
timeFrame: Change from baseline to 3 (end of intervention), 12, and 24 months after discharge
measure: Development of Post Thrombotic Syndrome (PTS) measured by the Villalta-score
timeFrame: Change from baseline to 3 (end of intervention), 12, and 24 months after discharge (end of intervention)
measure: Number of DVT related hospital contacts
timeFrame: From baseline to 3, 12, and 24 months after discharge
Other outcomes:
measure: Chronic inflammation
timeFrame: Change from baseline to 3, 12, and 24 months after discharge
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Region Hovedstaden
Study officials:
affiliation: Hvidovre University Hospital
name: Helle Juul-Larsen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Mette Merete Pedersen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Izzet Altinas, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kahn SR. Measurement properties of the Villalta scale to define and classify the severity of the post-thrombotic syndrome. J Thromb Haemost. 2009 May;7(5):884-8. doi: 10.1111/j.1538-7836.2009.03339.x. Epub 2009 Mar 6.
citation: Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available. Erratum In: Circulation. 2015 Feb 24;131(8):e359. doi: 10.1161/CIR.0000000000000185.
citation: Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
citation: Lee A, Gu CS, Vedantham S, Kearon C, Blostein M, Kahn SR. Performance of two clinical scales to assess quality of life in patients with post-thrombotic syndrome. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1257-1265.e2. doi: 10.1016/j.jvsv.2021.01.017. Epub 2021 Feb 4.
citation: Lamping DL, Schroter S, Kurz X, Kahn SR, Abenhaim L. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. J Vasc Surg. 2003 Feb;37(2):410-9. doi: 10.1067/mva.2003.152.