Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors

April 12, 2026 updated by: National Taiwan University Hospital

Effect of Sit-to-Stand Intervention in the Intensive Care Unit Survivors: A Randomized Controlled Trial

"Sit-to-stand" is key to independent living. For intensive care unit (ICU) survivors, failure to perform sit-to-stand results in bed-bound status, unable participating in important activities of daily living (ADLs) or instrumental ADLs. Recent studies indicated that 31% of ICU survivors remained bed-bound and unable to "sit-to-stand" after returning home. Our preliminary findings further indicated that 70% of ICU survivors who had the ICU-acquired weakness (ICU-AW) were unable to "sit-to-stand" one-month after ICU discharge.

The aim of this 3-year research project was to develop a feasible and effective "sit-to-stand" intervention (STS intervention) and to examine effects of the STS Care in improving ICU survivors' "sit-to-stand" ability, walking independently, physical function, and rates of bed-bound and mortality one year following ICU discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The trial was approved by the Human Research Ethics Committee at the study site before enrollment. Adult ICU patients (≥ 20 years) admitted consecutively to six medical ICUs of a university affiliated medical center was eligible for the study if they were unable to "sit-to-stand" independently at ICU discharge. Upon signing informed consent, participants will be first stratified by "able to stable sitting" or "unable to stable sitting" and then randomized separately into the intervention or usual care groups, according to computer-generated randomization tables. Participants in the intervention group received both usual care and the STS intervention. The hospital-based (up to 14 days) STS Intervention was provided daily by a independent trained nurse. STS care includes anti-gravity and resistant exercise (intensity based on patients' tolerance), repetitive sit-to-stand practice, and advice on sit-to-stand strategies. A comprehensive functional evaluation (rate of sit-to-stand, rate of walking independently, FSS-ICU scores, numbers of sit-to-stand repetitions in 30 seconds, MRC scores, muscle strength at knee extensors, scores of the barthel index for activities of daily living (ADL), scores of instrumental activities of daily living scale (IADL), the walking distance by the 6-minute walk test, rate of bed-bound status, and rate of mortality) was assessed by a blinded research nurse after ICU discharge at 48hours, 14 day, 1, 3, and 12 months. ICU-AW diagnosis (yes or no) at ICU discharge and daily caloric intake were selected a priori as pre-defined covariates and will be included in the analysis.

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • National Taiwan University Hospital
      • Taipei, National Taiwan University Hospital, Taiwan, 10055
        • Cheryl, Chia-Hui Chen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 20 years or older.
  • Admitted to ICU > 2 days.
  • Being unable to sit to stand independently at ICU discharge.

Exclusion Criteria:

  • Could not follow instructions
  • Bedridden before index hospitalization.
  • Ventilator use after ICU discharge .
  • Received palliative care.
  • had pre-existing neurological or musculoskeletal conditions that made sit-to-stand impossible (e.g. CVA, spinal cord injury, amputation or fracture of lower limb).
  • Placed on droplet or contact precausion (e.g. Open TB, SARS, COVID-19 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Participants in the control group received usual care.
Experimental: Sit-to-stand care group
Intervention was provided once daily by trained nurses for a maximum of 2 workweeks or until hospital discharge or death.
Other: Sit-to-stand Intervention
  1. Passive, anti-gravity range of motion(ROM) exercise of lower legs and sitting balance exercise.
  2. Sit-to-stand exercise
  3. Education on strategies to facilitate sit-to-stand movement and safe transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sit-to-stand independently
Time Frame: Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.
Participants are able to sit to stand independently, allowed armrest use
Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.
FSS-ICU scores
Time Frame: Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.
The FSS-ICU use 7-points score to evaluated 5 functional tasks, which includes rolling, supine-to -sit transfer, unsupported sitting, sit-to-stand transfer, and ambulation. Score range from 0 to 35, higher score indicated better physical performance. Walking independently will be analyzed.
Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.
Modified 30-second sit-to-stand test
Time Frame: 14day, 1, and 3 months after ICU discharge.
Measured by recording the numbers of sit-to-stand a person can complete in 30 seconds, alowed armrest used.
14day, 1, and 3 months after ICU discharge.
Muscle strength(kg) at knee extensors
Time Frame: Baseline within 48 hours. 14 day, 1, 3, and 12 months after ICU discharge
Measured by Hoggan MicroFET®2 in kg
Baseline within 48 hours. 14 day, 1, 3, and 12 months after ICU discharge
MRC scores
Time Frame: Baseline within 48 hours. 1, 3, and 12 months after ICU discharge
Measured by medical research council scale (MRC) in score, range from 0 to 60 score, higher score indicated better muscle strength
Baseline within 48 hours. 1, 3, and 12 months after ICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel index for activities of daily living (ADL)
Time Frame: Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.
Measured by ADL in score, range from 0-100 score, higher score indicated health condition
Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.
Instrumental activities of daily living scale (IADL)
Time Frame: Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.
Measured by IADL in score, range from 0 to 8 score, higher score indicated better health condition
Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.
The 6 minute walk test
Time Frame: 3 and 12 months after ICU discharge.
Measured by walked distance in 6 minutes(6MWT) in meter, range from 400 to 700 meters, higher value indicated better global health condition
3 and 12 months after ICU discharge.
Rate of bed-bound status
Time Frame: 1, 3, and 12 months after ICU discharge.
Obtained by family interview and medical record
1, 3, and 12 months after ICU discharge.
Rate of mortality
Time Frame: 1, 3, and 12 months after ICU discharge.
Obtained by family interview and medical record
1, 3, and 12 months after ICU discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

November 8, 2024

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202007109RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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