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

NCT06909240 | Recruiting

• 1 other identifier: H-22017283 / 2.3
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The DVT-Cph RCT aims to investigate:

1. 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. 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).

Conditions

Deep Vein Thrombosis (DVT)

Keywords

Physical activity

Outcome Measures

Primary Outcomes (1)

• The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire

  The VEINES-Qol is a validated disease-specific questionnaire for measuring quality of life among patients with a venous disease (Lamping D et al., 2003).

  Change from baseline to 3 months after discharge (end of intervention)

Secondary Outcomes (6)

• The Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) questionnaire

  Change from baseline to 12 and 24 months after discharge

• Health status measured by the EuroQol instrument (EQ-5D-5L)

  Change from baseline to 3 (end of intervention), 12, and 24 months after discharge

• Pain measured by the Visual Analogue Scale

  Recurrent weekly outcome from baseline to 3 months after discharge (end of intervention)

• Oedema

  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

  Change from baseline to 3 (end of intervention), 12, and 24 months after discharge (end of intervention)

Other Outcomes (1)

• Chronic inflammation

  Change from baseline to 3, 12, and 24 months after discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Other: Progressive gait training

Control

ACTIVE COMPARATOR

Other: Standard Care (in control arm)

Interventions

Progressive gait training OTHER

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 patient receives physiotherapist guidance via telephone on progressive gait training and is introduced to the next period of 14 days, where the activity level is maintained, and the goal is to further achive 2 x 20 mins/week of muscle-strengtening activities at moderate or greater intensity. After one and two months of training, the patient will be guided via telephone on maintaining their current level of physical activity or possibly on further progression.

Intervention

Standard Care (in control arm) OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or above
• First time lower extremity DVT
• Hospitalized at the Emergency Department
• Can cooperate cognitively and physically (patient reported)

You may not qualify if:

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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Capital Region, 2650, Denmark

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 25246013 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Motor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Helle Juul-Larsen, Ph.D.

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Mette Merete Pedersen, Ph.D.

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Izzet Altinas, M.D.

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mette Merete Pedersen, Ph.D.

CONTACT

+4538623350; mette.merete.pedersen@regionh.dk

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

CONTACT

+4529333262; ove.andersen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)