Extended Physiotherapy After Intensive Care Unit (ICU) Stay

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349994
• Other study ID #: Improvement project AFE
• Status: Completed
• Phase: N/A
• Start date: January 29, 2019
• Est. completion date: December 24, 2019

Study information

• Verified date: April 2022
• Source: Stockholm South General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 24, 2019
• Est. primary completion date: December 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years

• ICU stay >48 hours

• Understand the Swedish language

Exclusion Criteria:

• Patients palliative care with no intention of rehabilitation

Related Conditions & MeSH terms

• Critical Illness
• Physical Disability

Intervention

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.

Locations

Country	Name	City	State
Sweden	Stockholm South General Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of intervention	Number of planned interventions not delivered, and number of safety events.	Through study completion, an average of 2 weeks per participant
Secondary	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
Secondary	Readmission to ICU	Number of readmissions to ICU from ward, within each study group	Through study completion, an average of 2 weeks per participant