Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05349994
Other study ID # Improvement project AFE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness