Performance of two clinical scales to assess quality of life in patients with post-thrombotic syndrome.
Angela Lee, Chu-Shu Gu, Suresh Vedantham...
https://pubmed.ncbi.nlm.nih.gov/33548557/Actively 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-QOLSym 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)
M
Mette Merete Pedersen, Ph.D.
O
Ove Andersen, M.D., Ph.D.
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Hvidovre University Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Angela Lee, Chu-Shu Gu, Suresh Vedantham...
https://pubmed.ncbi.nlm.nih.gov/33548557/EuroQol Group
https://pubmed.ncbi.nlm.nih.gov/10109801/Susan R Kahn, Anthony J Comerota, Mary Cushman...
https://pubmed.ncbi.nlm.nih.gov/25246013/S R Kahn
https://pubmed.ncbi.nlm.nih.gov/19320818/M Herdman, C Gudex, A Lloyd...
https://pubmed.ncbi.nlm.nih.gov/21479777/Donna L Lamping, Sara Schroter, Xavier Kurz...
https://pubmed.ncbi.nlm.nih.gov/12563215/Hvidovre University Hospital
Lead Sponsor