Extended Physiotherapy After Intensive Care Unit (ICU) Stay

Extended Physiotherapy After Intensive Care Unit (ICU) Stay: A Prospective Before and After Study

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Physical Disability
• Intervention / Treatment: Other: Extended physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11883
    • Stockholm South General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients palliative care with no intention of rehabilitation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Intervention; 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.	Other: Extended physiotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in physical function according to Chelsea Critical Care Physical Assessment tool (CPAx)	Measures physical function in critically ill patients	Through study completion, an average of 2 weeks per participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of intervention	Number of planned interventions not delivered, and number of safety events.	Through study completion, an average of 2 weeks per participant
Length of stay at the ward	Number of days at the hospital ward after ICU discharge	Through study completion, an average of 2 weeks per participant
Readmission to ICU	Number of readmissions to ICU from ward, within each study group	Through study completion, an average of 2 weeks per participant

Collaborators and Investigators

• Sponsor: Stockholm South General Hospital
• Investigators: Principal Investigator: Katinka Siesage, Stockholm South General Hospital; Principal Investigator: Eva Alm- Joelsson, Stockholm South General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): December 24, 2019
• Study Completion (Actual): December 24, 2019

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Physical therapy; Physical function
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: Improvement project AFE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data available on request due to privacy/ethical restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No