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

Primary Purpose

Deep Vein Thrombosis

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years or above First time lower extremity DVT Hospitalized at the Emergency Department Exclusion Criteria: Patients without a Danish social security number Terminal patients Patients who do not understand or speak Danish

Sites / Locations

  • Hvidovre HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Early Initiated Physiotherapy Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Participation
That 50% of all eligible patients wish to participate
Dropout
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
That 80% respond to the questionnaire on quality of life upon admission
Adverse events
That no adverse events, which can be related to the intervention, are recorded during the training period

Secondary Outcome Measures

Full Information

First Posted
February 27, 2023
Last Updated
March 15, 2023
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05761119
Brief Title
Feasibility of an Early Initiated Physiotherapy Intervention Among Patients With Deep Vein Thrombosis.
Official Title
Feasibility of an Early Initiated Physiotherapy Intervention Among Patients With Deep Vein Thrombosis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
December 6, 2023 (Anticipated)
Study Completion Date
December 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Initiated Physiotherapy Intervention
Arm Type
Experimental
Arm Description
All participants will recieve the intervention (see Intervention for description) to investigate the feasibility.
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participation
Description
That 50% of all eligible patients wish to participate
Time Frame
Baseline to one month
Title
Dropout
Description
That less than 20% of the included patients wish to stop the intervention within the first month
Time Frame
Baseline to one month
Title
Respond rate regarding questionnaire on quality of life
Description
That 80% respond to the questionnaire on quality of life upon admission
Time Frame
Baseline to one month
Title
Adverse events
Description
That no adverse events, which can be related to the intervention, are recorded during the training period
Time Frame
Baseline to one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or above First time lower extremity DVT Hospitalized at the Emergency Department Exclusion Criteria: Patients without a Danish social security number Terminal patients Patients who do not understand or speak Danish
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette Merete Pedersen, Ph.D
Phone
004538623350
Email
mette.merete.pedersen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ove Andersen, M.D., Ph.D.
Phone
004529333262
Email
ove.andersen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helle Juul-Larsen, Ph.D
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mette Merete Pedersen, Ph.D
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
State/Province
Region Hovedstaden
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helle Juul-Larsen
Email
hjuu0009@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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