EuroQol--a new facility for the measurement of health-related quality of life.
EuroQol Group
https://pubmed.ncbi.nlm.nih.gov/10109801Actively Recruiting
Led by Hvidovre University Hospital · Updated on 2026-01-23
152
Participants Needed
1
Research Sites
95 weeks
Total Duration
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
Progressive Gait Training After First-time Deep Venous Thrombosis: Clinical Effectiveness and Involved Mecanisms (The DVT-Cph RCT)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Hvidovre University Hospital
Hvidovre, Capital Region, Denmark, 2650
Actively Recruiting
M
Mette Merete Pedersen, Ph.D.
O
Ove Andersen, M.D., Ph.D.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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