Simultaneous Recumbent Cycling and Cognitive Training

NCT04556227 | Recruiting

• 1 other identifier: 40007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Intensive care units (ICU) provide life-saving care for nearly five million people annually. Up to 80% of patients receiving care in an ICU experience at least one episode of delirium. Delirium, an acute episodic display of confused thinking and unawareness, predicts impaired cognition and accelerated cognitive decline which negatively impacts quality of life (QOL) long after hospital discharge. The average age of ICU patients is 52 years. These middle-age (MA) ICU survivors need cognitive interventions that are well planned, accessible, and effective to improve cognition and prevent accelerated decline so they can resume their previous QOL and enter older age with optimized cognitive function. Physical exercise and cognitive training independently improve cognition and emerging evidence indicates that combining these two approaches produces even greater effects on cognition. Community-based rehabilitation centers are accessible for MAICU survivors to engage in physical activity; cognitive training could easily be added. Approaches in which a patient engages in physical exercise and cognitive training concurrently is an understudied intervention for all ICU survivors, especially those who are middle-aged. Study aims are to investigate the feasibility and acceptability of a simultaneous recumbent cycling and cognitive training intervention (SRCCT) for MAICU survivors who experienced at least one delirium episode during their ICU stay. Feasibility will be determined by systematically evaluating research team training, participant recruitment, randomization, implementation, and intervention fidelity. Acceptability will be evaluated via a satisfaction, preferences, burden, and participant-suggested improvements survey. The SRCCT effect sizes will be calculated comparing multiple data point cognition scores between an SRCCT group and a usual care control group. Upon completion, investigators expect to understand the feasibility and acceptability of the SRCCT delivered in community-based rehabilitation centers, and the combined effect of SRCCT on cognition and QOL for middle-aged ICU survivors who experienced an episode of ICU delirium. The hypothesis is that study participants who engage in physical exercise and cognitive training concurrently will have a greater improvement in cognition and QOL than physical exercise training alone.

Conditions

Delirium; Impaired Cognition

Keywords

Intensive Care Unit; ICU-Survivors; Cognitive Training; Recumbent Cycling; Executive Functioning

Outcome Measures

Primary Outcomes (2)

• Feasibility of Simultaneous Recumbent Cycling and Cognitive Training Survey

  Feasibility of participant recruitment, randomization, intervention, intervention fidelity, and data collection. Less problems to overcome with recruitment, randomization, administering intervention, and data collection the more feasible the study.

  At study completion, approximately 36 weeks.

• Acceptability of Simultaneous Recumbent Cycling and Cognitive Training Survey

  Acceptability Survey: Determine satisfaction and burden including text suggestions for study improvement. Likert type scale 1-4; higher score means more acceptable.

  Approximately 24 weeks.

Secondary Outcomes (3)

• Change in Cognition using Montreal Cognitive Assessment Test

  Screening for inclusion, 2 weeks,12 weeks, 24 weeks, and at study completion, approximately 36 weeks.

• Change in perceived cognition using Patient-Reported Outcomes Measurement Information System, Applied Cognition Short Form-8.

  Baseline,12 weeks, 24 weeks, and at study completion, approximately 36 weeks.

• Quality of life using Patient-Reported Outcomes Measurement Information System Global-10 Short Form

  Baseline,12 weeks, and at study completion, approximately 36 weeks.

Study Arms (2)

Simultaneous Cycle/Cognitive Training

EXPERIMENTAL

After discharge from the hospital the group will engage in recumbent cycling with simultaneous cognitive training on a tablet.

Behavioral: Simultaneous Cycle/Cognitive Training

Usual Care

NO INTERVENTION

After discharge from the hospital the group will complete baseline activies.

Interventions

Simultaneous Cycle/Cognitive Training BEHAVIORAL

Two weeks after discharge from the hospital the intervention group will complete recumbent cycle for 1 hour, 2x/wk. for 12 weeks (24 sessions). 10-minute cycle warm-up, 40-minute simultaneous cycling and cognitive training, 10-minute cool down. Cycling based on provider prescription and progression of physical recovery. Cognitive training program from Posit Science, Brain HQ (TM) progressive level of difficulty. Total duration of 60 minutes.

Simultaneous Cycle/Cognitive Training

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 45-64 years
• Admitted to medical or surgical ICUs (SLH \& TMC) for \>24 hours
• English-speaking
• Discharged home
• Able to provide consent
• Access to a telephone
• One or more delirium episode in ICU (positive CAM-ICU).

You may not qualify if:

• Cancer diagnosis with short life expectancy determined by the Primary Care Provider (unable to complete the study within time frame)
• Chemotherapy (drug-induced impaired cognition)
• Diagnosed vascular dementia or other neurodegenerative diseases (e.g. Alzheimer or Parkinson disease)
• Documented alcohol consumption ≥5 drinks/day (withdrawal delirium tremens)
• Corrected vision\<20/80 Snellen chart (unable to do cognitive exercises on the tablet)
• Examiner rated low hearing or communicative ability that would interfere with intervention and assessments
• Positive CAM-ICU (delirium) at hospital discharge
• Unable to participate in rehabilitation (abnormal 6 min walk test)
• Any physical condition preventing recumbent cycling
• Recent documented history of drug abuse.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• St. Luke's Hospital, Kansas City, Missouri: collaborator

Study Sites (1)

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

RECRUITING

Related Publications (40)

• Utilization of Intensive Care Services, 2011 #185. https://hcup-us.ahrq.gov/reports/statbriefs/sb185-Hospital-Intensive-Care-Units-2011.jsp. Accessed September 2, 2019.

  BACKGROUND

• Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.

  PMID: 21946660 BACKGROUND

• Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.

  PMID: 11730446 BACKGROUND

• Khan BA, Lasiter S, Boustani MA. CE: critical care recovery center: an innovative collaborative care model for ICU survivors. Am J Nurs. 2015 Mar;115(3):24-31; quiz 34, 46. doi: 10.1097/01.NAJ.0000461807.42226.3e.

  PMID: 25674682 BACKGROUND

• Desai SV, Law TJ, Needham DM. Long-term complications of critical care. Crit Care Med. 2011 Feb;39(2):371-9. doi: 10.1097/CCM.0b013e3181fd66e5.

  PMID: 20959786 BACKGROUND

• Rothenhausler HB, Ehrentraut S, Stoll C, Schelling G, Kapfhammer HP. The relationship between cognitive performance and employment and health status in long-term survivors of the acute respiratory distress syndrome: results of an exploratory study. Gen Hosp Psychiatry. 2001 Mar-Apr;23(2):90-6. doi: 10.1016/s0163-8343(01)00123-2.

  PMID: 11313077 BACKGROUND

• Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.

  PMID: 24088092 BACKGROUND

• Griffiths J, Hatch RA, Bishop J, Morgan K, Jenkinson C, Cuthbertson BH, Brett SJ. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Crit Care. 2013 May 28;17(3):R100. doi: 10.1186/cc12745.

  PMID: 23714692 BACKGROUND

• Kamdar BB, Huang M, Dinglas VD, Colantuoni E, von Wachter TM, Hopkins RO, Needham DM; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome Network. Joblessness and Lost Earnings after Acute Respiratory Distress Syndrome in a 1-Year National Multicenter Study. Am J Respir Crit Care Med. 2017 Oct 15;196(8):1012-1020. doi: 10.1164/rccm.201611-2327OC.

  PMID: 28448162 BACKGROUND

• Norman BC, Jackson JC, Graves JA, Girard TD, Pandharipande PP, Brummel NE, Wang L, Thompson JL, Chandrasekhar R, Ely EW. Employment Outcomes After Critical Illness: An Analysis of the Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors Cohort. Crit Care Med. 2016 Nov;44(11):2003-2009. doi: 10.1097/CCM.0000000000001849.

  PMID: 27171492 BACKGROUND

• Tropea J, LoGiudice D, Liew D, Gorelik A, Brand C. Poorer outcomes and greater healthcare costs for hospitalised older people with dementia and delirium: a retrospective cohort study. Int J Geriatr Psychiatry. 2017 May;32(5):539-547. doi: 10.1002/gps.4491. Epub 2016 Apr 25.

  PMID: 27114271 BACKGROUND

• Zhu X, Yin S, Lang M, He R, Li J. The more the better? A meta-analysis on effects of combined cognitive and physical intervention on cognition in healthy older adults. Ageing Res Rev. 2016 Nov;31:67-79. doi: 10.1016/j.arr.2016.07.003. Epub 2016 Jul 14.

  PMID: 27423932 BACKGROUND

• Bruderer-Hofstetter M, Rausch-Osthoff AK, Meichtry A, Munzer T, Niedermann K. Effective multicomponent interventions in comparison to active control and no interventions on physical capacity, cognitive function and instrumental activities of daily living in elderly people with and without mild impaired cognition - A systematic review and network meta-analysis. Ageing Res Rev. 2018 Aug;45:1-14. doi: 10.1016/j.arr.2018.04.002. Epub 2018 Apr 18.

  PMID: 29679658 BACKGROUND

• Lasiter S, Snodgrass B, Thompson M, Chrisman M. Physical activity and cognitive training as interventions to enhance cognitive functioning: A systematic review. unpublished manuscript.

  BACKGROUND

• Northey JM, Cherbuin N, Pumpa KL, Smee DJ, Rattray B. Exercise interventions for cognitive function in adults older than 50: a systematic review with meta-analysis. Br J Sports Med. 2018 Feb;52(3):154-160. doi: 10.1136/bjsports-2016-096587. Epub 2017 Apr 24.

  PMID: 28438770 BACKGROUND

• Gross AL, Parisi JM, Spira AP, Kueider AM, Ko JY, Saczynski JS, Samus QM, Rebok GW. Memory training interventions for older adults: a meta-analysis. Aging Ment Health. 2012;16(6):722-34. doi: 10.1080/13607863.2012.667783.

  PMID: 22423647 BACKGROUND

• Jackson JC, Ely EW, Morey MC, Anderson VM, Denne LB, Clune J, Siebert CS, Archer KR, Torres R, Janz D, Schiro E, Jones J, Shintani AK, Levine B, Pun BT, Thompson J, Brummel NE, Hoenig H. Cognitive and physical rehabilitation of intensive care unit survivors: results of the RETURN randomized controlled pilot investigation. Crit Care Med. 2012 Apr;40(4):1088-97. doi: 10.1097/CCM.0b013e3182373115.

  PMID: 22080631 BACKGROUND

• Ohman H, Savikko N, Strandberg TE, Pitkala KH. Effect of physical exercise on cognitive performance in older adults with mild cognitive impairment or dementia: a systematic review. Dement Geriatr Cogn Disord. 2014;38(5-6):347-65. doi: 10.1159/000365388. Epub 2014 Aug 21.

  PMID: 25171577 BACKGROUND

• Yu F, Kolanowski A. Facilitating aerobic exercise training in older adults with Alzheimer's disease. Geriatr Nurs. 2009 Jul-Aug;30(4):250-9. doi: 10.1016/j.gerinurse.2008.11.001. Epub 2009 Mar 9.

  PMID: 19665667 BACKGROUND

• Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00134-013-3136-0. Epub 2013 Nov 21.

  PMID: 24257969 BACKGROUND

• Leavell HR, Clark EG. Textbook of Preventive Medicine. New York: McGraw-Hill; 1953

  BACKGROUND

• Leavell HR, Clark EG. Preventive Medicine for the Doctor in His Community, An Epidemiological Approach. 2nd ed. New York: McGraw-Hill; 1958.

  BACKGROUND

• Berney S, Haines K, Skinner EH, Denehy L. Safety and feasibility of an exercise prescription approach to rehabilitation across the continuum of care for survivors of critical illness. Phys Ther. 2012 Dec;92(12):1524-35. doi: 10.2522/ptj.20110406. Epub 2012 Aug 9.

  PMID: 22879441 BACKGROUND

• Shields GE, Wells A, Doherty P, Heagerty A, Buck D, Davies LM. Cost-effectiveness of cardiac rehabilitation: a systematic review. Heart. 2018 Sep;104(17):1403-1410. doi: 10.1136/heartjnl-2017-312809. Epub 2018 Apr 13.

  PMID: 29654096 BACKGROUND

• 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.

  PMID: 23883525 BACKGROUND

• Lasiter S, Oles SK, Mundell J, London S, Khan B. Critical Care Follow-up Clinics: A Scoping Review of Interventions and Outcomes. Clin Nurse Spec. 2016 Jul-Aug;30(4):227-37. doi: 10.1097/NUR.0000000000000219.

  PMID: 27309787 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• PROMIS: Clinical Outcomes Assessment. https://commonfund.nih.gov/promis/index. Accessed September 7, 2019.

  BACKGROUND

• Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.

  PMID: 17102966 BACKGROUND

• Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.

  PMID: 15071384 BACKGROUND

• Zhao J, Yao L, Wang C, Sun Y, Sun Z. The effects of cognitive intervention on cognitive impairments after intensive care unit admission. Neuropsychol Rehabil. 2017 Apr;27(3):301-317. doi: 10.1080/09602011.2015.1078246. Epub 2015 Aug 27.

  PMID: 26313129 BACKGROUND

• Zheng G, Xia R, Zhou W, Tao J, Chen L. Aerobic exercise ameliorates cognitive function in older adults with mild cognitive impairment: a systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2016 Dec;50(23):1443-1450. doi: 10.1136/bjsports-2015-095699. Epub 2016 Apr 19.

  PMID: 27095745 BACKGROUND

• Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12.

  PMID: 28912076 BACKGROUND

• Vaportzis E, Niechcial MA, Gow AJ. A systematic literature review and meta-analysis of real-world interventions for cognitive ageing in healthy older adults. Ageing Res Rev. 2019 Mar;50:110-130. doi: 10.1016/j.arr.2019.01.006. Epub 2019 Jan 29.

  PMID: 30707947 BACKGROUND

• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

  PMID: 31078660 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Hamilton DM, Haennel RG. Validity and reliability of the 6-minute walk test in a cardiac rehabilitation population. J Cardiopulm Rehabil. 2000 May-Jun;20(3):156-64. doi: 10.1097/00008483-200005000-00003.

  PMID: 10860197 BACKGROUND

• Saffer BY, Lanting SC, Koehle MS, Klonsky ED, Iverson GL. Assessing cognitive impairment using PROMIS((R)) applied cognition-abilities scales in a medical outpatient sample. Psychiatry Res. 2015 Mar 30;226(1):169-72. doi: 10.1016/j.psychres.2014.12.043. Epub 2015 Jan 8.

  PMID: 25639374 BACKGROUND

• Howland M, Tatsuoka C, Smyth KA, Sajatovic M. Evaluating PROMIS((R)) applied cognition items in a sample of older adults at risk for cognitive decline. Psychiatry Res. 2017 Jan;247:39-42. doi: 10.1016/j.psychres.2016.10.072. Epub 2016 Nov 1.

  PMID: 27863317 BACKGROUND

• Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.

  PMID: 19543809 BACKGROUND

MeSH Terms

Conditions

Delirium; Cognition Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rita S Lasiter, PhD

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

• Matthew S Chrisman, PhD

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita S Lasiter, PhD

CONTACT

816-235-6766; LasiterR@umkc.edu

Matthew S Chrisman, PhD

CONTACT

816-235-5709; chrismanms@umkc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Upon leaving ICU and admission to general hospital room, study staff will go to patients' room to recruit and consent ICU survivor for study start date approximately two weeks after discharge. Randomize study participant using block randomization program. Document data on patients who decline consent and wish to be randomized to usual care or to the intervention group. This is a single masked (participant) study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 21, 2020
• Study Start: December 3, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)