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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Hvidovre University Hospital — Hvidovre

Публикации

• 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

Идентификаторы

NCT: NCT06909240 · H-22017283 / 2.3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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