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

ICU Survivor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04640441
• Other study ID #: 202007109RINB
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: National Taiwan University Hospital
• Contact: Chen Chia-Hui, PhD
• Phone: 02-23123456
• Email: cherylchen[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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" care (STS Care). A randomized controlled trial (RCT) design is proposed to examine effects of the STS Care in improving ICU patients' "sit-to-stand" ability, physical function, and rates of bed-bound and mortality one year following ICU discharge. 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 remain sitting upright without falling" or "unable to remain sitting upright" 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 Care. The hospital-based (up to 14 days) STS Care, which was provided daily by the same trained nurse, consisted of nurse-supervised 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 (success rate of sit to stand, scores of FSS-ICU, scores of MRC muscle scale, 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, numbers of sit-to-stand repetitions in 30 seconds, rate of bed-bound status, rate of mortality) was assessed by blinded research nurses after ICU discharge at 5 time points:48hours, 14 day, 1, 3, and 12 months.

Description:

For this stratified randomization and single blinding study, participants (≧20 years) who are screened with failed sit-to-stand ability after discharged from the National Taiwan University Hospital medication ICU 48hours will be enrolled in the study. In the assignment procedure, the participants will be stratified by a stabilized sitting posture and unable stabilized sitting posture, and then the participants are randomized to the experiment group and control group. The experiment group will accept regular care and an extra STS bedside care protocol once a day for two weeks or discharged within two weeks. In contrast, the control group will accept regular care. All participants will be followed for one year after ICU discharge at 5 time points:48 hours, 14day,1, 3, 12 months. A comprehensive functional evaluation (success rate of sit to stand, scores of FSS-ICU, scores of MRC muscle scale, 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, numbers of sit-to-stand repetitions in 30 seconds, rate of bed-bound status, rate of mortality) will be performed. Estimated 206 participants will be enrolled and followed one year after ICU discharge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 273
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age 20 years or older.
• Admitted for ICU treatment > 2 days.
• Unable to sit-to-stand by ICU discharge.

Exclusion Criteria:

• Unable to follow command.
• Bedridden before index hospitalization.
• Ventilator dependent after ICU discharge .
• Received palliative care.
• Co-morbidities of the trunk or lower limbs unable to ambulate due to neuromuscular or musculoskeletal etiology (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 )

Related Conditions & MeSH terms

• ICU Survivor
• Unable to Sit-to-stand

Intervention

Other:
• Sit-to-stand care
Passive range of motion(ROM) exercise of lower legs, active ROM exercise of lower legs, and sitting balance exercise, 20~30 min, once daily. Anti-gravity ROM exercise of lower leg, resistance exercise of low leg, and sitting balance exercise, 20~30min, once daily. Stepping exercise and sit-to-stand exercise, 20~30min, once daily.

Locations

Country	Name	City	State
Taiwan	Cheryl, Chia-Hui Chen, PhD	Taipei	National Taiwan University Hospital

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sit-to-stand independently (percent)	Evaluated by one successful and independent sit-to-stand, allowed armrest use	Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.
Primary	scores of FSS-ICU	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.	Baseline within 48 hours. 14 day, 1, and 3 months after ICU discharge.
Primary	scores of MRC muscle scale	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.
Primary	muscle strength(kg) at knee extensors	Measured by Hoggan MicroFET®2 in kg	Baseline within 48 hours. 14 day, 1, 3, and 12 months after ICU discharge.
Primary	30-second sit-to-stand test	Measured by recording the numbers of sit-to-stand a person can complete in 30 seconds	14day, 1, and 3 months after ICU discharge.
Secondary	Barthel index for activities of daily living (ADL)	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.
Secondary	Instrumental activities of daily living scale (IADL)	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.
Secondary	Rate of bed-bound status (percent)	Obtained by family interview and medical record	1, 3, and 12 months after ICU discharge.
Secondary	Rate of mortality (percent)	Obtained by family interview and medical record	1, 3, and 12 months after ICU discharge.
Secondary	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	3 and 12 months after ICU discharge.