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

NCT05761119 | Completed

• 1 other identifier: H-22017283 / 2.1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (4)

• Participation

  That 50% of all eligible patients wish to participate

  Baseline to one month

• Dropout

  That less than 20% of the included patients wish to stop the intervention within the first month

  Baseline to one month

• Respond rate regarding questionnaire on quality of life

  That 80% respond to the questionnaire on quality of life upon admission

  Baseline to one month

• Adverse events

  That no adverse events, which can be related to the intervention, are recorded during the training period

  Baseline to one month

Study Arms (1)

Early Initiated Physiotherapy Intervention

EXPERIMENTAL

All participants will recieve the intervention (see Intervention for description) to investigate the feasibility.

Other: Physical activity

Interventions

Physical activity OTHER

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.

Early Initiated Physiotherapy Intervention

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

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 (2)

Hvidovre Hospital

Hvidovre, Capital Region, 2650, Denmark

Location

Department of Physiotherapy, Næstved-Slagelse-Ringsted Hospital

Slagelse, 4200, Denmark

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Helle Juul-Larsen, Ph.D

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Mette Merete Pedersen, Ph.D

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: March 15, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)