NCT04729634

Brief Summary

Background Thoracic or abdominal surgeries are followed by a shorter or longer period of immobilization and after major surgery there is a higher risk of developing cardiorespiratory complications. To prevent these complications, the patient is encouraged to change position and exercise in bed, get out of bed as early and as much as possible after the operation and to breathe with or without aids. There is no general definition of early mobilization and may start within a few hours to a few days after surgery. There is currently a lack of knowledge nationally and internationally about when the mobilization starts and what it contains. Many patients also receive breathing training in connection with the surgery. There is currently no consensus on which method is preferable for which groups of patients. There are similarities and differences in practice in the world regarding postoperative breathing training. There are studies that have mapped practice after primarily thoracic surgery but also abdominal surgery. However, there are no studies that have mapped when the prescribed breathing training starts after different types of operations. The purpose of the study is to map when mobilization and breathing training starts after abdominal and thoracic surgery and what is then performed Method The study will be carried out as a quality follow-up with mapping of practice. Patients ≥ 18 years of age who are undergoing a planned or acute open, keyhole or robot-assisted surgery, who are extubated and who breathe spontaneously will be included. Exclusion criteria are completed plastic, trauma, orthopedic or transplant surgery. The material will be recruited from Swedish university hospitals and county hospitals for 20 days of surgery (Monday through Thursday) for five consecutive weeks. Clinical benefit The study will mean that clinical practice is presented which, with regard to mobilization, is the first study ever that will present when this takes place and what is done and, with regard to breathing training, the first that shows when this training is initiated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,492

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

January 4, 2021

Last Update Submit

August 13, 2022

Conditions

Keywords

ImmobilizationAbdominal surgeryThoracic surgeryBreathing training

Outcome Measures

Primary Outcomes (6)

  • When mobilization starts after surgery

    Time from termination of anaesthesia to when mobilization starts, ie when the patients are sitting with the legs over the edge of the bed

    Within 24 hours after surgery

  • Mobilization- Content

    Content of the mobilization performed i.e. which level of mobilization (sitting on the edge of the bed, standing by the bed, sitting in a chair and walking) which is reached.

    Within 24 hours after surgery

  • Mobilization- Duration

    Duration of the mobilization performed, minutes

    Within 24 hours after surgery

  • When any intervention with breathing exercises starts after surgery

    Time from termination of anesthesia to when the breathing exercise starts

    Within 24 hours after surgery

  • Breathing exercise- Content

    Type of breathing exercise, as deep breathing, positive expiratory pressure or incentive spirometry.

    Within 24 hours after surgery

  • Breathing exercise- Intensity

    Intensity of breathing exercise prescribed, sessions/time.

    Within 24 hours after surgery

Study Arms (1)

Mobilization and breathing training

OTHER

Usual clinical care

Other: Mobilization

Interventions

Mobilization and breathing exercises according to clinical care

Also known as: Breathing training
Mobilization and breathing training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • undergoing a planned or acute open, laparoscopic or robot-assisted surgeon in the thorax or abdomen
  • who are extubated within 24 h of surgery
  • breathe spontaneously within 24 h of surgery

You may not qualify if:

  • reconstructive-, trauma-, transplantation- or orthopedic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Related Publications (3)

  • Fagevik Olsen M, Svensson-Raskh A, Westerdahl E, Nygren Bonnier M, Reeve J, Sehlin M. Current practice of targeted breathing exercises after abdominal and cardiothoracic surgery: a national multicentre observational study. Physiotherapy. 2025 Jun;127:101462. doi: 10.1016/j.physio.2024.101462. Epub 2024 Dec 24.

  • Westerdahl E, Lilliecrona J, Sehlin M, Svensson-Raskh A, Nygren-Bonnier M, Olsen MF. First initiation of mobilization out of bed after cardiac surgery - an observational cross-sectional study in Sweden. J Cardiothorac Surg. 2024 Jul 4;19(1):420. doi: 10.1186/s13019-024-02915-4.

  • Fagevik Olsen M, Sehlin M, Westerdahl E, Schandl A, Block L, Nygren-Bonnier M, Svensson-Raskh A. First mobilisation after abdominal and cardiothoracic surgery: when is it actually performed? A national, multicentre, cross-sectional study. BMJ Open. 2024 Feb 29;14(2):e082239. doi: 10.1136/bmjopen-2023-082239.

MeSH Terms

Conditions

Heart Diseases

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Monika Fagevik Olsén, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The patients will not be aware of the study activities
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: A cohort of patients followed over time
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 28, 2021

Study Start

September 1, 2021

Primary Completion

February 28, 2022

Study Completion

June 30, 2022

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations