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Unable to Sit-to-standNCT04640441

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

A study testing Sit-to-stand Intervention in people with Unable to Sit-to-stand and ICU Survivor, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

"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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Unable to Sit-to-stand, ICU Survivor
What is being tested?
Sit-to-stand Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
1 siteTaiwan
Study dates
14 Sep 2020to 8 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 )

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Cheryl, Chia-Hui Chen, PhD

    Taipei, National Taiwan University Hospital, 10055

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Sit-to-stand Intervention
Keywords
Sit-to-stand, Functional decline, Intensive care units, Nursing intervention, Randomized controlled trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sit-to-stand InterventionOther

    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
Study groups in NCT04640441
Study groupRoleWhat they receive
Control groupNo interventionParticipants in the control group received usual care.
Sit-to-stand care groupExperimentalIntervention was provided once daily by trained nurses for a maximum of 2 workweeks or until hospital discharge or death.
Receives: Other: Sit-to-stand Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sit-to-stand independently

    Participants are able to sit to stand independently, allowed armrest use

    Measured: Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.

  2. FSS-ICU scores

    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.

    Measured: Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.

  3. Modified 30-second sit-to-stand test

    Measured by recording the numbers of sit-to-stand a person can complete in 30 seconds, alowed armrest used.

    Measured: 14day, 1, and 3 months after ICU discharge.

  4. Muscle strength(kg) at knee extensors

    Measured by Hoggan MicroFET®2 in kg

    Measured: Baseline within 48 hours. 14 day, 1, 3, and 12 months after ICU discharge

  5. MRC scores

    Measured by medical research council scale (MRC) in score, range from 0 to 60 score, higher score indicated better muscle strength

    Measured: Baseline within 48 hours. 1, 3, and 12 months after ICU discharge

Secondary outcomes (5)
  1. Barthel index for activities of daily living (ADL)

    Measured by ADL in score, range from 0-100 score, higher score indicated health condition

    Measured: Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.

  2. Instrumental activities of daily living scale (IADL)

    Measured by IADL in score, range from 0 to 8 score, higher score indicated better health condition

    Measured: Baseline within 48 hours. 1, 3, and 12 months after ICU discharge.

  3. Rate of bed-bound status

    Obtained by family interview and medical record

    Measured: 1, 3, and 12 months after ICU discharge.

  4. Rate of mortality

    Obtained by family interview and medical record

    Measured: 1, 3, and 12 months after ICU discharge.

  5. The 6 minute walk test

    Measured by walked distance in 6 minutes(6MWT) in meter, range from 400 to 700 meters, higher value indicated better global health condition

    Measured: 3 and 12 months after ICU discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start14 Sep 2020
  3. Primary completion31 Dec 2023
  4. Study completion8 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants who are unable to perform sit-to-stand independently within 48 houre of ICU discharge were enrolled. In the assignment procedure, participants were stratified by "able to stable sitting" or "unable to stable sitting" and then 1:1 randomly assigned to the intervention or usual care groups. Participants in intervention group receive both usual care and an STS care once daily for two workweeks or discharged within two workweeks or death. In contrast, control group will accept usual care. All participants will be assessed at 48 hours,14day, 1, 3, and 12 months following ICU discharge. 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, ADL, and IADL) and rates of bed-bound status and mortality will be assessed by a outcome assessor.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04640441
Sponsor's protocol ID
202007109RINB
Status last verified
Jan 2025
First submitted
10 Sep 2020
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Applebaum EV, Breton D, Feng ZW, Ta AT, Walsh K, Chasse K, Robbins SM. Modified 30-second Sit to Stand test predicts falls in a cohort of institutionalized older veterans. PLoS One. 2017 May 2;12(5):e0176946. doi: 10.1371/journal.pone.0176946. eCollection 2017.

    PubMed 28464024
  • Bednarik J, Vondracek P, Dusek L, Moravcova E, Cundrle I. Risk factors for critical illness polyneuromyopathy. J Neurol. 2005 Mar;252(3):343-51. doi: 10.1007/s00415-005-0654-x. Epub 2005 Mar 30.

    PubMed 15791390
  • Bloomfield SA. Changes in musculoskeletal structure and function with prolonged bed rest. Med Sci Sports Exerc. 1997 Feb;29(2):197-206. doi: 10.1097/00005768-199702000-00006.

    PubMed 9044223
  • Bodilsen AC, Klausen HH, Petersen J, Beyer N, Andersen O, Jorgensen LM, Juul-Larsen HG, Bandholm T. Prediction of Mobility Limitations after Hospitalization in Older Medical Patients by Simple Measures of Physical Performance Obtained at Admission to the Emergency Department. PLoS One. 2016 May 19;11(5):e0154350. doi: 10.1371/journal.pone.0154350. eCollection 2016.

    PubMed 27195499
  • Bohannon RW, Bubela DJ, Wang YC, Magasi SR, Gershon RC. Adequacy of belt-stabilized testing of knee extension strength. J Strength Cond Res. 2011 Jul;25(7):1963-7. doi: 10.1519/JSC.0b013e3181e4f5ce.

    PubMed 21399535
  • Bruun IH, Maribo T, Norgaard B, Schiottz-Christensen B, Mogensen CB. A prediction model to identify hospitalised, older adults with reduced physical performance. BMC Geriatr. 2017 Dec 7;17(1):281. doi: 10.1186/s12877-017-0671-5.

    PubMed 29216838
  • Ciesla N, Dinglas V, Fan E, Kho M, Kuramoto J, Needham D. Manual muscle testing: a method of measuring extremity muscle strength applied to critically ill patients. J Vis Exp. 2011 Apr 12;(50):2632. doi: 10.3791/2632.

    PubMed 21505416
  • Connolly B, Thompson A, Douiri A, Moxham J, Hart N. Exercise-based rehabilitation after hospital discharge for survivors of critical illness with intensive care unit-acquired weakness: A pilot feasibility trial. J Crit Care. 2015 Jun;30(3):589-98. doi: 10.1016/j.jcrc.2015.02.002. Epub 2015 Feb 7.

    PubMed 25703957
  • De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

    PubMed 12472328
  • Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.

    PubMed 24247473
  • Fetterplace K, Beach LJ, MacIsaac C, Presneill J, Edbrooke L, Parry SM, Rechnitzer T, Curtis R, Berney S, Deane AM, Denehy L. Associations between nutritional energy delivery, bioimpedance spectroscopy and functional outcomes in survivors of critical illness. J Hum Nutr Diet. 2019 Dec;32(6):702-712. doi: 10.1111/jhn.12659. Epub 2019 Apr 29.

    PubMed 31034122
  • Fortes-Filho SQ, Aliberti MJR, Apolinario D, Melo-Fortes JA, Sitta MC, Jacob-Filho W, Garcez-Leme LE. Role of Gait Speed, Strength, and Balance in Predicting Adverse Outcomes of Acutely Ill Older Outpatients. J Nutr Health Aging. 2020;24(1):113-118. doi: 10.1007/s12603-019-1279-6.

    PubMed 31886817
  • Gross MM, Stevenson PJ, Charette SL, Pyka G, Marcus R. Effect of muscle strength and movement speed on the biomechanics of rising from a chair in healthy elderly and young women. Gait Posture. 1998 Dec 1;8(3):175-185. doi: 10.1016/s0966-6362(98)00033-2.

    PubMed 10200407
  • Huang M, Chan KS, Zanni JM, Parry SM, Neto SG, Neto JA, da Silva VZ, Kho ME, Needham DM. Functional Status Score for the ICU: An International Clinimetric Analysis of Validity, Responsiveness, and Minimal Important Difference. Crit Care Med. 2016 Dec;44(12):e1155-e1164. doi: 10.1097/CCM.0000000000001949.

    PubMed 27488220
  • Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.

    PubMed 20978258

Questions about this trial

What is this clinical trial studying?

A study testing Sit-to-stand Intervention in people with Unable to Sit-to-stand and ICU Survivor, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sit-to-stand independently (time frame: Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04640441, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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