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Extended Physiotherapy After Intensive Care Unit (ICU) Stay

Primary Purpose

Critical Illness, Physical Disability

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Extended physiotherapy
Sponsored by
Stockholm South General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Physical therapy, Physical function

Eligibility Criteria

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

Inclusion Criteria:

  • Age over 18 years
  • ICU stay >48 hours
  • Understand the Swedish language

Exclusion Criteria:

• Patients palliative care with no intention of rehabilitation

Sites / Locations

  • Stockholm South General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Standard amount of physical therapy at surgical wards in an urban hospital, corresponding to 1.75 physiotherapy employment on weekdays divided on four wards with a total of approx. 40-48 patients.

Extended physiotherapy with an extra 0.5 employment on weekdays, leading to 1-2 physiotherapy session per day for the study participants in the intervention group.

Outcomes

Primary Outcome Measures

Changes in physical function according to Chelsea Critical Care Physical Assessment tool (CPAx)
Measures physical function in critically ill patients

Secondary Outcome Measures

Feasibility of intervention
Number of planned interventions not delivered, and number of safety events.
Length of stay at the ward
Number of days at the hospital ward after ICU discharge
Readmission to ICU
Number of readmissions to ICU from ward, within each study group

Full Information

First Posted
April 13, 2022
Last Updated
April 22, 2022
Sponsor
Stockholm South General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05349994
Brief Title
Extended Physiotherapy After Intensive Care Unit (ICU) Stay
Official Title
Extended Physiotherapy After Intensive Care Unit (ICU) Stay: A Prospective Before and After Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
December 24, 2019 (Actual)
Study Completion Date
December 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stockholm South General 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
Patients in an Intensive Care Unit (ICU) are at great risk of muscle atrophy and neuromuscular complications, that could lead to respiratory complications, decreased physical functioning and deteriorated health related quality of life. The objective is to investigate if extended physical therapy in a general ward could lead to increased physical functioning for post-ICU patients.The study hypothesis is that extended physical therapy would lead to increased physical function at hospital discharge compared to standard amount of physical therapy.
Detailed Description
The study design is a before and after study. A control group was included for three months and received standard amount of physical therapy at surgical wards, corresponding to 1.75 employment. An intervention group was then included for six months and received extended amount of physical therapy corresponding to an extra 0.5 employment for study participants (2-4 patients/day). The primary outcome was physical function measured with the Chelsea Critical Care Physical Assessment Tool (CPAx), in the ICU and the surgical ward.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Physical Disability
Keywords
Physical therapy, Physical function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study design was a before and after study. A control group was included for three months and received standard care. An intervention group was then included for six months and received extended amount of physical therapy.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard amount of physical therapy at surgical wards in an urban hospital, corresponding to 1.75 physiotherapy employment on weekdays divided on four wards with a total of approx. 40-48 patients.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Extended physiotherapy with an extra 0.5 employment on weekdays, leading to 1-2 physiotherapy session per day for the study participants in the intervention group.
Intervention Type
Other
Intervention Name(s)
Extended physiotherapy
Intervention Description
At admission to the surgical ward after ICU care, participants received an individual rehabilitation plan developed in collaboration with the participants and the ward-based physiotherapist. The rehabilitation plan included specified exercises for 1- 2 sessions of approximately 30 minutes a day. For example breathing exercises, practicing transfer in and out of bed and from sitting to standing, stairclimbing, and walking with or without walking aids.
Primary Outcome Measure Information:
Title
Changes in physical function according to Chelsea Critical Care Physical Assessment tool (CPAx)
Description
Measures physical function in critically ill patients
Time Frame
Through study completion, an average of 2 weeks per participant
Secondary Outcome Measure Information:
Title
Feasibility of intervention
Description
Number of planned interventions not delivered, and number of safety events.
Time Frame
Through study completion, an average of 2 weeks per participant
Title
Length of stay at the ward
Description
Number of days at the hospital ward after ICU discharge
Time Frame
Through study completion, an average of 2 weeks per participant
Title
Readmission to ICU
Description
Number of readmissions to ICU from ward, within each study group
Time Frame
Through study completion, an average of 2 weeks per participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years ICU stay >48 hours Understand the Swedish language Exclusion Criteria: • Patients palliative care with no intention of rehabilitation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katinka Siesage
Organizational Affiliation
Stockholm South General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva Alm- Joelsson
Organizational Affiliation
Stockholm South General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm South General Hospital
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data available on request due to privacy/ethical restrictions.

Learn more about this trial

Extended Physiotherapy After Intensive Care Unit (ICU) Stay

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