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

NCT ID: NCT05761119

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2024-08-01

Brief Summary

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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

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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.

Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Early Initiated Physiotherapy Intervention

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

Group Type EXPERIMENTAL

Physical activity

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ove Andersen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helle Juul-Larsen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Mette Merete Pedersen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre Hospital

Hvidovre, Capital Region, Denmark

Site Status RECRUITING

Department of Physiotherapy, Næstved-Slagelse-Ringsted Hospital

Slagelse, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Mette Merete Pedersen, Ph.D

Role: CONTACT

004538623350

Ove Andersen, M.D., Ph.D.

Role: CONTACT

004529333262

Facility Contacts

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Helle Juul-Larsen

Role: primary

Simone Bruun Lynggard, MSc

Role: primary

Other Identifiers

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H-22017283 / 2.1

Identifier Type: -

Identifier Source: org_study_id

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