A Study Promoting Critical Illness Recovery in the Elderly

Critical Illness Clinical Trial

— ASPIRE  

Official title:

ASPIRE: A Study Promoting Critical Illness Recovery in the Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02963558
• Other study ID #: IRB00039558
• Secondary ID: 5UL1TR001420-031
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: November 2024

Study information

• Verified date: June 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proposal will test the hypothesis that EARLY application of a novel early rehabilitation therapy in critically ill patients will improve functional outcomes, and change the functional trajectory of this population. A pilot study of early mobilization with a cycle ergometer will be performed and translate into humans the pre-clinical mechanisms that may mediate the effects of early mobility. A second phase of the study was added in September 2019, which will focus on clinical outcomes.

Description:

Patients will be randomized to intervention or control groups. Patients will receive therapies according to their group assignment until hospital discharge or day 28, whichever comes first. The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. In-bed cycle ergometry has been shown to be safe and feasible in the critically ill and is approved for use in this population. Subjects enrolled in the intervention arm will be screened at least 5 days per week to evaluate if they meet pre-defined safety criteria based on other studies of early mobilization and cycling in the Intensive Care Unit (ICU). Patients will be positioned in the semi-recumbent position for cycling as per ICU guidelines. The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The investigators will start with passive cycling and the patient may progress to active-assisted and active cycling. The goal duration of cycling will be 30 minutes. Subjects will receive in-bed cycling at least 5 times per week for the duration of the ICU stay or until day 14, whichever comes first. During cycling and therapy sessions, the physical therapist will also complete a case report form noting vital signs, level of mobilization, and other safety measures. In addition to cycling, the intervention arm will receive early physical therapy (PT). This physical therapy will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that were previously developed. Patients will receive 30 minutes of Physical Therapy (PT) at least 5 times per week when they are conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through the different levels of PT with an emphasis on ambulation. Physical therapy for the intervention arm patients will continue while hospitalized through day 28. Outpatient therapy will be provided at the discretion of the patient's treating physicians. The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their physicians.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: November 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Age =55 years old
• Admission to Wake Forest Baptist Medical Center Medical Intensive Care Unit
• Acute Hypoxic respiratory failure on mechanical ventilation for <48 hours with a P:F ratio of <300 (or equivalent S:F ratio)
• Previously Functional (over past 3 months, as reported by proxy):

Physical Function: Able to walk 4 m (with or without assistive device)

Exclusion Criteria:

• Neuromuscular Disease
• Cardiopulmonary Arrest with return of spontaneous circulation <6 hrs
• Palliative Goals of Care; witholding life-sustaining therapy
• Elevated Intracranial Pressure (>20 mm Hg)
• BMI>45; absolute weight >= 150 kg
• Inability to cycle (including absent limbs, body length <1.5m, body habitus not fitting the cycle, inflammatory arthritis, significant joint problems including inability to bend arms/legs; pelvic and/or LE fracture, LE bypass surgery)
• Pregnancy
• Unable to speak English
• Use of continuous neuromuscular blockade
• Temporary Pacemaker or Swan Ganz catheter or femoral ECMO catheter/IABP
• Rhabdomyolysis with most recent CK >5000
• Clinical diagnosis of dementia on medication
• Moribund
• Possible Exclusion: If the patient is on spine precautions, a discussion with the spine team will be necessary to determine eligibility for the study

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Critical Care
• Critical Illness
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• cycle ergometry
The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Center for Advancing Translational Sciences (NCATS), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (18)

Bakhru RN, Wiebe DJ, McWilliams DJ, Spuhler VJ, Schweickert WD. An Environmental Scan for Early Mobilization Practices in U.S. ICUs. Crit Care Med. 2015 Nov;43(11):2360-9. doi: 10.1097/CCM.0000000000001262. — View Citation

Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937. — View Citation

Camargo Pires-Neto R, Fogaca Kawaguchi YM, Sayuri Hirota A, Fu C, Tanaka C, Caruso P, Park M, Ribeiro Carvalho CR. Very early passive cycling exercise in mechanically ventilated critically ill patients: physiological and safety aspects--a case series. PLoS One. 2013 Sep 9;8(9):e74182. doi: 10.1371/journal.pone.0074182. eCollection 2013. — View Citation

Denehy L, Skinner EH, Edbrooke L, Haines K, Warrillow S, Hawthorne G, Gough K, Hoorn SV, Morris ME, Berney S. Exercise rehabilitation for patients with critical illness: a randomized controlled trial with 12 months of follow-up. Crit Care. 2013 Jul 24;17(4):R156. doi: 10.1186/cc12835. — View Citation

Ely EW, Wheeler AP, Thompson BT, Ancukiewicz M, Steinberg KP, Bernard GR. Recovery rate and prognosis in older persons who develop acute lung injury and the acute respiratory distress syndrome. Ann Intern Med. 2002 Jan 1;136(1):25-36. — View Citation

Files DC, Liu C, Pereyra A, Wang ZM, Aggarwal NR, D'Alessio FR, Garibaldi BT, Mock JR, Singer BD, Feng X, Yammani RR, Zhang T, Lee AL, Philpott S, Lussier S, Purcell L, Chou J, Seeds M, King LS, Morris PE, Delbono O. Therapeutic exercise attenuates neutrophilic lung injury and skeletal muscle wasting. Sci Transl Med. 2015 Mar 11;7(278):278ra32. doi: 10.1126/scitranslmed.3010283. — View Citation

Files DC, Sanchez MA, Morris PE. A conceptual framework: the early and late phases of skeletal muscle dysfunction in the acute respiratory distress syndrome. Crit Care. 2015 Jul 2;19(1):266. doi: 10.1186/s13054-015-0979-5. — View Citation

Herridge MS, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, Ferguson ND, Adhikari NK, Rudkowski JC, Meggison H, Skrobik Y, Flannery J, Bayley M, Batt J, Santos CD, Abbey SE, Tan A, Lo V, Mathur S, Parotto M, Morris D, Flockhart L, Fan E, Lee CM, Wilcox ME, Ayas N, Choong K, Fowler R, Scales DC, Sinuff T, Cuthbertson BH, Rose L, Robles P, Burns S, Cypel M, Singer L, Chaparro C, Chow CW, Keshavjee S, Brochard L, Hebert P, Slutsky AS, Marshall JC, Cook D, Cameron JI; RECOVER Program Investigators (Phase 1: towards RECOVER); Canadian Critical Care Trials Group. The RECOVER Program: Disability Risk Groups and 1-Year Outcome after 7 or More Days of Mechanical Ventilation. Am J Respir Crit Care Med. 2016 Oct 1;194(7):831-844. doi: 10.1164/rccm.201512-2343OC. — View Citation

Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802. — View Citation

Jolley SE, Dale CR, Hough CL. Hospital-level factors associated with report of physical activity in patients on mechanical ventilation across Washington State. Ann Am Thorac Soc. 2015 Feb;12(2):209-15. doi: 10.1513/AnnalsATS.201410-480OC. — View Citation

Jolley SE, Regan-Baggs J, Dickson RP, Hough CL. Medical intensive care unit clinician attitudes and perceived barriers towards early mobilization of critically ill patients: a cross-sectional survey study. BMC Anesthesiol. 2014 Oct 1;14:84. doi: 10.1186/1471-2253-14-84. eCollection 2014. — View Citation

Kho ME, Martin RA, Toonstra AL, Zanni JM, Mantheiy EC, Nelliot A, Needham DM. Feasibility and safety of in-bed cycling for physical rehabilitation in the intensive care unit. J Crit Care. 2015 Dec;30(6):1419.e1-5. doi: 10.1016/j.jcrc.2015.07.025. Epub 2015 Jul 29. — View Citation

Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e. — View Citation

Moss M, Nordon-Craft A, Malone D, Van Pelt D, Frankel SK, Warner ML, Kriekels W, McNulty M, Fairclough DL, Schenkman M. A Randomized Trial of an Intensive Physical Therapy Program for Patients with Acute Respiratory Failure. Am J Respir Crit Care Med. 2016 May 15;193(10):1101-10. doi: 10.1164/rccm.201505-1039OC. — View Citation

Needham DM, Korupolu R, Zanni JM, Pradhan P, Colantuoni E, Palmer JB, Brower RG, Fan E. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. doi: 10.1016/j.apmr.2010.01.002. — View Citation

Parry SM, Berney S, Warrillow S, El-Ansary D, Bryant AL, Hart N, Puthucheary Z, Koopman R, Denehy L. Functional electrical stimulation with cycling in the critically ill: a pilot case-matched control study. J Crit Care. 2014 Aug;29(4):695.e1-7. doi: 10.1016/j.jcrc.2014.03.017. Epub 2014 Mar 26. — View Citation

Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14. — View Citation

Walsh TS, Salisbury LG, Merriweather JL, Boyd JA, Griffith DM, Huby G, Kean S, Mackenzie SJ, Krishan A, Lewis SC, Murray GD, Forbes JF, Smith J, Rattray JE, Hull AM, Ramsay P; RECOVER Investigators. Increased Hospital-Based Physical Rehabilitation and Information Provision After Intensive Care Unit Discharge: The RECOVER Randomized Clinical Trial. JAMA Intern Med. 2015 Jun;175(6):901-10. doi: 10.1001/jamainternmed.2015.0822. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients in the intervention arm the are able to undergo a cycling session	Feasibility will be assessed by quantifying the ability to apply the MOTOmed device for at least a 15-minute session within 48 hours of randomization and meeting safety criteria.	up to 48 hours after randomization
Primary	Short Physical Performance Battery (SPPB)	Based on timed measures of standing balance, walking speed, and ability to rise from a chair. Each measure is assigned a score ranging from 0 to 4, with a total possible summary score of 12. A higher score denotes a better outcome.	Intensive Care Unit (ICU) discharge (through study completion, on average day 7)
Secondary	Short Physical Performance Battery (SPPB)	Based on timed measures of standing balance, walking speed, and ability to rise from a chair. Each measure is assigned a score ranging from 0 to 4, with a total possible summary score of 12. A higher score denotes a better outcome.	Hospital discharge (through study completion, on average day 10)
Secondary	Handgrip strength	Assessed with a Jamar hand-held dynamometer.	Hospital discharge (through study completion, on average day 10)
Secondary	Intensive Care Unit (ICU) Length of Stay	Number of days	ICU discharge (through study completion, on average day 7)
Secondary	Hospital Length of Stay	Number of days	Hospital discharge (through study completion, on average day 10)
Secondary	Number of Hospital Readmissions		up to 6 months
Secondary	Number of Emergency Department Visits		up to 6 months
Secondary	Number of Ventilator Free Days		Up to 28 days from hospital admission or hospital discharge, whichever is first
Secondary	Mortality	total number affected	up through 6 months post-discharge
Secondary	Short Form-36	Assesses quality of life. Score ranges from 0 to 100 with a higher score denoting a higher outcome.	through study completion (hospital discharge, 3 months post-discharge, 6 months post-discharge)
Secondary	Accelerometer Activity Monitoring Results	Used to determine activity.	Up through two weeks after discharge
Secondary	Muscle Ultrasound--thickness, size, echogenicity; DXA scans	Obtain preliminary data to estimate the treatment effect size	up to 6 months
Secondary	Translational Outcomes	MuRF1, NFKB, myofiber size and type, etc	up to 6 months