Reporting of physical activity levels in post ICU discharge patients

Not yet recruiting

• Conditions: Bacterial infection, unspecified, (2) ICD-10 Condition: I519||Heart disease, unspecified, (3) ICD-10 Condition: K77||Liver disorders in diseases classified elsewhere, (4) ICD-10 Condition: E874||Mixed disorder of acid-base balance, (5) ICD-10 Condition: J969||Respiratory failure, unspecified,

• Registration Number: CTRI/2023/08/056404
• Lead Sponsor: Sakshi Surve

Brief Summary

Approval to conduct the study is obtained from Institutional Research Committee(IRC), MCHP, MAHE and Institutional Ethics committee(IEC), Kasturba hospital, Manipal. This is  followed by Clinical Trials Registry India (CTRI) registration. Following eligibility screening, a consent form will be taken from all the patients and purpose of the study will be explained. Demographics of the patients, disease status and its clinical characteristics, information regarding current medications and ongoing physiotherapy treatment for the patient will be obtained on the first day of physiotherapy referral.  Reporting of physical activity profiles of the patients will be done at two points namely: at ICU discharge and at one month telephonic follow up. As the patients transfer from the ICU to the wards, we do not control, take into account or interfere in any standardized physiotherapy protocol that the patients might be undergoing. On the day of ICU discharge the patients will be evaluated using MRC sumscore and functional status would be assessed using Functional Status Scale-ICU. 7. At one month post discharge, the physical activity levels of the patients will be assessed using PASE questionnaire over telephonic follow up where the patients would be scored appropriately on the basis of their past seven days’ physical activity recall. Statistical analysis of the obtained data would be carried out using SPSS (version 16) software

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Individuals of any gender aged between 45-75 years, minimum 24 hours of ICU stay, All patients admitted to the ICUs with a physiotherapy referral.

Exclusion Criteria

Pregnant women, unconscious patients(GCS score<12), known cases of any cognitive impairment or mental retardation, fracture limiting mobility, patients receiving any renal replacement therapy, renal transplant, cancer therapy in last 6 months, patients with prior neurological conditions or currently admitted to neurological ICUs, patients readmitted to the ICU.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical activity levels using PASE(Physical Activity Scale for the Elderly) questionnaire	At 1 month post ICU discharge

Secondary Outcome Measures

Name	Time	Method
Medical Research Council sumscore	At ICU discharge
Functional Status score (FSS-ICU)	At ICU discharge

Trial Locations

Locations (1)

Kasturba Hospital; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hospital

🇮🇳Udupi, KARNATAKA, India

Dr G Arun Maiya

Principal investigator

9845350823

arun.maiya@manipal.edu