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

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761119
• Other study ID #: H-22017283 / 2.1
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Hvidovre University Hospital
• Contact: Mette Merete Pedersen, Ph.D
• Phone: 004538623350
• Email: mette.merete.pedersen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Physical activity
The focus of the intervention is on exercises that can improve venous return, and consists of progressive walking training at moderate and high intensity as well as guidance on physical activity. 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 hit 30 min. times/day at moderate intensity. After 14 days, the patient receives physiotherapeutic guidance in physical activity and is introduced to the next period of 14 days, where the activity level is maintained, and the goal is to further achieve 2 x 20 min./week of high-intensity physical activity. After one month of training, the patient will be guided on maintaining and possibly progressing physical activity.

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre	Region Hovedstaden
Denmark	Department of Physiotherapy, Næstved-Slagelse-Ringsted Hospital	Slagelse

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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