Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06909240

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

Led by Hvidovre University Hospital · Updated on 2026-01-23

152

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding progressive gait training to standard care improves quality of life for patients experiencing their first episode of lower extremity deep venous thrombosis (DVT). This randomized controlled trial also aims to understand how gait training may affect disease progression, late complications like post-thrombotic syndrome, and the severity of venous thromboembolism. The study is supported by Hvidovre University Hospital and is linked with related feasibility and cohort studies to enhance research insights. Participants will be assigned to one of two groups: an intervention group receiving progressive gait training plus standard care, or a control group receiving standard care alone. The progressive gait training involves a 14-day introductory period with moderate intensity walking exercises guided by a physiotherapist, followed by telephone guidance for muscle-strengthening activities over the next weeks. Standard care includes ultrasound diagnostics, anticoagulant medication, compression stockings, and outpatient clinic visits during the first 90 days after diagnosis. During the study, participants will complete quality of life questionnaires at baseline, 3, 12, and 24 months after discharge, including the VEINES-QOL/Sym and EQ-5D-5L instruments. Researchers will monitor pain weekly during the first 3 months, assess edema, post-thrombotic syndrome development, and count DVT-related hospital contacts. The study begins in November 2025 and lasts up to 24 months post-discharge, with ongoing safety monitoring and long-term follow-up to evaluate outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or above
  • First time lower extremity deep venous thrombosis
  • Hospitalized at the Emergency Department
  • Can cooperate cognitively and physically (patient reported)
Not Eligible

You will not qualify if you...

  • Patients without a Danish social security number
  • Terminal patients
  • Patients who do not understand or speak Danish

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants receive either progressive gait training involving a 14-day introductory period followed by telephone-guided training for up to 3 months, or standard care with compression ultrasound, anticoagulant medication, compression stockings, and outpatient clinic visits.

Visits to outpatient anticoagulation clinic within the first 14 days and at 90 days; telephone guidance sessions during treatment for gait training participants

Follow-up

Duration - Up to 24 months after discharge

Participants are monitored for quality of life, pain, oedema, development of post thrombotic syndrome, and hospital contacts up to 24 months after discharge.

Assessments at 3, 12, and 24 months after discharge

Trial Site Locations

Total: 1 location

1

Hvidovre University Hospital

Hvidovre, Capital Region, Denmark, 2650

Actively Recruiting

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Research Team

M

Mette Merete Pedersen, Ph.D.

O

Ove Andersen, M.D., Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association.

Susan R Kahn, Anthony J Comerota, Mary Cushman...

https://pubmed.ncbi.nlm.nih.gov/25246013

Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life.

Donna L Lamping, Sara Schroter, Xavier Kurz...

https://pubmed.ncbi.nlm.nih.gov/12563215