Feasibility of an Early Initiated Physiotherapy Intervention Among Patients With Deep Vein Thrombosis.

Not Applicable

Recruiting

• Conditions: Deep Vein Thrombosis
• Interventions: Other: Physical activity

• Registration Number: NCT05761119
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

The project will investigate the feasibility of a physiotherapy intervention for patients diagnosed with deep vein thrombosis for whom a physiotherapy intervention is not currently part of clinical practice in Denmark. Specifically, the project will investigate if an early-initiated physiotherapy intervention for patients who are admitted acutely with first-time deep vein thrombosis (DVT), can be carried out and is experienced as valuable for the patients.

Detailed Description

This study aims to investigate whether it is possible for patients diagnosed with DVT to complete early mobilization combined with progressive walking during their hospitalization and the first month after discharge.

This study is twofold. Part one is a clinical cohort study and will investigate the feasibility using quantitative outcomes. Part two is a qualitative study using interviews to investigate the patients' experiences with and attititudes towards a physiotherapy guided intervention of early mobilization combined with progressive walking during their hospitalization and one month after discharge to their own home.

If the physiotherapy intervention is deemed feasible and acceptable, a future randomized controlled trial will investigate the effect of the intervention on quality of life.

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-09
• Study Start: 2023-03-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. 18 years or above
2. First time lower extremity DVT
3. Hospitalized at the Emergency Department

Exclusion Criteria

1. Patients without a Danish social security number
2. Terminal patients
3. Patients who do not understand or speak Danish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early Initiated Physiotherapy Intervention	Physical activity	All participants will recieve the intervention (see Intervention for description) to investigate the feasibility.

Primary Outcome Measures

Name	Time	Method
Participation	Baseline to one month	That 50% of all eligible patients wish to participate
Dropout	Baseline to one month	That less than 20% of the included patients wish to stop the intervention within the first month
Respond rate regarding questionnaire on quality of life	Baseline to one month	That 80% respond to the questionnaire on quality of life upon admission
Adverse events	Baseline to one month	That no adverse events, which can be related to the intervention, are recorded during the training period

Trial Locations

Locations (2)

Hvidovre Hospital; 🇩🇰 Hvidovre, Region Hovedstaden, Denmark

Department of Physiotherapy, Næstved-Slagelse-Ringsted Hospital; 🇩🇰 Slagelse, Denmark