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

Sponsor
Hvidovre University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05761119
Collaborator
(none)
24
1
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physical activity
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility of an Early Initiated Physiotherapy Intervention Among Patients With Deep Vein Thrombosis.
Anticipated Study Start Date :
Mar 6, 2023
Anticipated Primary Completion Date :
Dec 6, 2023
Anticipated Study Completion Date :
Dec 6, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Early Initiated Physiotherapy Intervention

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

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.

Outcome Measures

Primary Outcome Measures

  1. Participation [Baseline to one month]

    That 50% of all eligible patients wish to participate

  2. Dropout [Baseline to one month]

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

  3. Respond rate regarding questionnaire on quality of life [Baseline to one month]

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

  4. Adverse events [Baseline to one month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hvidovre University Hospital

Investigators

  • Principal Investigator: Helle Juul-Larsen, Ph.D, Hvidovre University Hospital
  • Principal Investigator: Mette Merete Pedersen, Ph.D, Hvidovre University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ove Andersen, Professor, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT05761119
Other Study ID Numbers:
  • H-22017283 / 2.1
First Posted:
Mar 9, 2023
Last Update Posted:
Mar 9, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2023