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

Hvidovre University Hospital

Status: Enrolling

Conditions: Deep Vein Thrombosis (DVT)

Treatments: Other: Standard Care (in control arm); Other: Progressive gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT06909240

H-22017283 / 2.3

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Other: Progressive gait training

Control

Active Comparator group

Treatment:

Other: Standard Care (in control arm)