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

Overview

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

• Other Progressive 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
• Other Standard 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.

Primary outcome measures

• The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire [Time frame: Change from baseline to 3 months after discharge (end of intervention)]

Secondary outcome measures (6)

• The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire [Time frame: Change from baseline to 12 and 24 months after discharge]
• Health status measured by the EuroQol instrument (EQ-5D-5L) [Time frame: Change from baseline to 3 (end of intervention), 12, and 24 months after discharge]
• Pain measured by the Visual Analogue Scale [Time frame: Recurrent weekly outcome from baseline to 3 months after discharge (end of intervention)]
• Oedema [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 [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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Denmark · 1 center

• Hvidovre University Hospital — Hvidovre

Publications

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. PMID 10109801
• 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. PMID 19320818
• 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 PMID 25246013
• 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. PMID 21479777
• 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. PMID 33548557
• 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. PMID 12563215

Identifiers

NCT: NCT06909240 · H-22017283 / 2.3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗