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Completed

NCT Number: NCT04640441

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

"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.

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Key information

Conditions

Unable to Sit-to-stand ICU Survivor

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cheryl, Chia-Hui Chen, PhD

Taipei, National Taiwan University Hospital, 10055, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Sit-to-stand Intervention

Other
  • Passive, anti-gravity range of motion(ROM) exercise of lower legs and sitting balance exercise.
  • Sit-to-stand exercise
  • Education on strategies to facilitate sit-to-stand movement and safe transfer

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

Secondary outcomes

  1. 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

  2. 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

  3. Rate of bed-bound status

    Time frame: 1, 3, and 12 months after ICU discharge.

    Obtained by family interview and medical record

  4. Rate of mortality

    Time frame: 1, 3, and 12 months after ICU discharge.

    Obtained by family interview and medical record

  5. 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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Nov 23, 2020
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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