Brummel 2014b.

Methods	Single‐centre, randomized controlled trial with 3‐month follow‐up; a feasibility study Setting: medical and surgical ICU Country: USA Groups: usual care vs. physical therapy only vs cognitive and physical therapy Period: February 2011 to April 2012
Participants	Sample size: 87 randomized (16/16/32 in arms) Included 18 years and older Participants treated for respiratory failure or septic or both, cardiogenic or haemorrhagic shock who resided within 120 miles of city of hospital Excluded Critically ill for more than 72 hours Admitted to the ICU for more than 5 days in the previous 30 days Moribund state Severe pre‐existing dementia or physical disability in ADL Active substance abuse Active psychiatric disorder Homeless Missing: all are accounted for in flowchart.
Interventions	Patients were assigned in a 1:1:2 manner Intervention I: 1 daily physical therapy session (passive ROM, active exercise, sit at edge of bed, stand/transfer, ADL training and walk). Duration of physical therapy session is not described. Intervention II: 1 daily physical therapy session and 20 minutes. cognitive therapy sessions twice daily during hospitalization. Patients exhibiting impaired executive functioning or impaired functional mobility continued outpatient cognitive therapy for 6 weeks (6 sessions) using goal management training. Control: usual care (physical therapy approximately once every 6 days).
Outcomes	Primary Number of patients who could participate in cognitive therapy (feasibility) Secondary Delirium‐/coma‐free days Ventilator‐free days ICU and hospital LOS Mortality Cognitive and functional outcomes Measured by: CAM‐ICU and RASS Adverse events: 1 patient experienced acute back pain accompanied by hypotensive urgency during physical therapy
Notes	Conclusion: delirium‐/coma‐free days did not differ between groups Funding Dr Brummel was supported by the National Heart Lung and Blood Institute of the National Institutes of Health (NIH) under award number T32HL087738 and is supported by the Vanderbilt Clinical and Translational Scholars Program and the National Institute on Aging of the NIH under award number R03AG045095 Dr Jackson is supported by the National Institute on Aging of the NIH under award number K23AG031322 Dr Girard is supported by the National Institute on Aging of the NIH under award number K23AG034257 Dr Pandharipande is supported by the VA Clinical Science Research and Development Service (VA Career Development Award) and the National Heart Lung and Blood Institute of the NIH under award number R01HL111111 Dr Hughes is supported by a Foundation for Anesthesia Education and Research Mentored Research Training Grant Dr Ely is supported by the VA Clinical Science Research and Development Service (VA MERITReview Award) and the National Institute on Aging of the NIH under award numbers R01AG027472 and R01AG035117 Dr Gill was supported by K24AG021507, K07AG043587, and P30AG021342 Drs Girard, Dittus, and Ely are supported by the Veterans Affairs Tennessee Valley Geriatric Research, Education and Clinical Center (GRECC). This work is also supported by the National Center for Advancing Translational Science under award number UL1TR000445 Conflict of interest Dr Ely has received research grants and honoraria from Hospira, Orion, and Abbott Dr Girard has received honoraria from Hospira Dr Pandharipande has received a research grant from Hospira and honoraria from Hospira, and Orion Pharma Ms Pun has received honoraria from Hospira Ms Boehm has received honoraria from Hospira Dr Gill has received honoraria from Novartis The other authors report no financial disclosures Study number: NCT01270269 Conference proceeding: 1 Contact with authors: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated permuted‐block randomization scheme
Allocation concealment (selection bias)	Low risk	Group allocations were printed and placed in sealed opaque envelopes
Incomplete outcome data (attrition bias) All outcomes	Low risk	Flowchart accounts for all patients throughout the study
Selective reporting (reporting bias)	Unclear risk	In the online protocol: NCT01270269 and in a protocol paper (Brummel 2012), a considerably large number of secondary outcome measures were listed for follow‐up at both 3 and 6 months. At 3 months, data on Activity‐Specific Balance Confidence, AD8 (assessment of change in cognitive abilities), General and Employment scale, Canadian Study of Health and Aging Frailty scale were planned, but these outcomes were not reported.
Other bias	Low risk	A post hoc analysis showed that the study was underpowered (38%) to detect a meaningful 1.5% change in the tower test (executive function) Risk of a type 1 error
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not possible to blind patients or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Only outcomes measured at follow‐up were collected by outcome assessor. Data on delirium was presumably collected by study authors. (page 372).