Clinical trial NCT03682523: The Breaking "Bad Rest" Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care
Official title: The Breaking "Bad Rest" Study: Interrupting Sedentary Time to Reverse Frailty Levels in Acute Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Keywords: Frailty
Hospitalization
Acute care
older adults
intervention
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be classified into three strata based on their baseline mobility measured with the HABAM. Within each strata, patients will be randomly allocated to the control (n=25) and intervention (n=25) groups in temporal blocks. In the event of Covid-19 related interruptions to the study, temporal blocks aim to keep the number of participants in the intervention and control groups similar at all times.

This stratified, block randomised control trial design will ensure a similar distribution of patient characteristics in the control and intervention groups and will safeguard against possible interruptions due to Covid-19.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will determine whether an intervention aimed at reducing sedentary time in patients admitted to acute care will result in decreased frailty levels at hospital discharge, compared to the current standard of care. All patients will be fitted with accelerometers then randomised to the control or intervention group. The control group will receive only standard of care while in hospital. Participants in the intervention group will engage in daily goal setting for time out-of-bed and have access to real-time feedback on a bedside monitor. Participants in the intervention group will also received assisted mobilization if they have not met their daily goal by the late afternoon. The main outcome is frailty, assessed by a frailty index.

Detailed description: The objective of this study is to determine if an intervention designed to reduce sedentary time during a patient's stay in acute care will reduce patient's frailty levels more so than current standard of care. This study will be conducted at a single-centre, but will be a stratified, block randomised control trial. Fifty participants will be recruited within 24 hours of admission to a geriatric acute care unit. Both groups will be fitted with a device that measures sedentary and active time (accelerometer). Participants in the intervention group will have a daily goal for activity and will be provided with real-time feedback on attainment of that goal displayed on a bedside tablet. Participants in the intervention group who do not independently achieve their goal will be assisted in reducing their sedentary time in the afternoon and/or early evening to the maximum level of their ability; this level will be determined in consultation with the healthcare team. The primary outcome is a change in frailty during hospitalization, measured using a 30-item frailty index. The data collection phase is approximately 10 months. Data analysis will take an additional six months (16 months total). Knowledge-users will be involved during all stages of the project. The data generated from this study will enable us to scale up this intervention nationally and internationally. If the intervention is successful, it will warrant a study to implement the intervention as part of standard care. Ultimately, this study will inform guidelines to limit patients' sedentary behaviors in acute care.

Eligibility criteria: Inclusion Criteria:

* Anticipated hospital length of stay \>1 day
* Patient or care partner able to communicate in English

Exclusion Criteria:

* Patient unable to provide informed consent and care partner not available to provide consent
* Bedridden prior to hospital admission
* Previous participation in our study (i.e. readmission during data collection phase)
* End-of-life or waiting for long-term care facility
* Patient is admitted to a shared room with a current study participant.

Primary outcomes:
measure: Change in the Frailty Index
timeFrame: Change from baseline frailty up to a median 14 day hospital length of stay
Secondary outcomes:
measure: Change in the Frailty Index
timeFrame: Change from baseline frailty up to a median 14 days hospital length of stay, and 30 days after hospital discharge
measure: Change in upright time
timeFrame: Change from baseline upright time up to a median 14 day hospital length of stay
measure: Change in upright bouts
timeFrame: Change from baseline upright bouts up to a median 14 day hospital length of stay
measure: Change in mobility: Hierarchical Assessment of Balance and Mobility (HABAM)
timeFrame: Change from baseline mobility scores up to a median 14 day hospital length of stay
measure: Change in balance: Hierarchical Assessment of Balance and Mobility (HABAM)
timeFrame: Change from baseline balance scores up to a median 14 day hospital length of stay
measure: Falls
timeFrame: From baseline to 30 days after hospital discharge
measure: Hospital length of stay
timeFrame: From baseline up to a median 14 day hospital length of stay
measure: In-hospital mortality
timeFrame: From baseline up to a median 14 day hospital length of stay
measure: Hospital readmissions
timeFrame: From baseline up to 30 days after hospital discharge
measure: Safety evaluation (frequency of adverse events)
timeFrame: From baseline up to a median 14 day hospital length of stay
measure: Cost
timeFrame: From baseline up to 30 days after hospital discharge
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Assistant Professor, Department of Medicine, Dalhousie University
name: Olga Theou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoogerduijn JG, Buurman BM, Korevaar JC, Grobbee DE, de Rooij SE, Schuurmans MJ. The prediction of functional decline in older hospitalised patients. Age Ageing. 2012 May;41(3):381-7. doi: 10.1093/ageing/afs015. Epub 2012 Feb 28.
citation: Covinsky KE, Palmer RM, Fortinsky RH, Counsell SR, Stewart AL, Kresevic D, Burant CJ, Landefeld CS. Loss of independence in activities of daily living in older adults hospitalized with medical illnesses: increased vulnerability with age. J Am Geriatr Soc. 2003 Apr;51(4):451-8. doi: 10.1046/j.1532-5415.2003.51152.x.
citation: Chong E, Ho E, Baldevarona-Llego J, Chan M, Wu L, Tay L. Frailty and Risk of Adverse Outcomes in Hospitalized Older Adults: A Comparison of Different Frailty Measures. J Am Med Dir Assoc. 2017 Jul 1;18(7):638.e7-638.e11. doi: 10.1016/j.jamda.2017.04.011. Epub 2017 Jun 3.
citation: Romero-Ortuno R, Forsyth DR, Wilson KJ, Cameron E, Wallis S, Biram R, Keevil V. The Association of Geriatric Syndromes with Hospital Outcomes. J Hosp Med. 2017 Feb;12(2):83-89. doi: 10.12788/jhm.2685.
citation: Romero-Ortuno R, Wallis S, Biram R, Keevil V. Clinical frailty adds to acute illness severity in predicting mortality in hospitalized older adults: An observational study. Eur J Intern Med. 2016 Nov;35:24-34. doi: 10.1016/j.ejim.2016.08.033. Epub 2016 Sep 2.
citation: Baldwin C, van Kessel G, Phillips A, Johnston K. Accelerometry Shows Inpatients With Acute Medical or Surgical Conditions Spend Little Time Upright and Are Highly Sedentary: Systematic Review. Phys Ther. 2017 Nov 1;97(11):1044-1065. doi: 10.1093/ptj/pzx076.
citation: Kortebein P, Ferrando A, Lombeida J, Wolfe R, Evans WJ. Effect of 10 days of bed rest on skeletal muscle in healthy older adults. JAMA. 2007 Apr 25;297(16):1772-4. doi: 10.1001/jama.297.16.1772-b. No abstract available.
citation: Lipnicki DM, Gunga HC. Physical inactivity and cognitive functioning: results from bed rest studies. Eur J Appl Physiol. 2009 Jan;105(1):27-35. doi: 10.1007/s00421-008-0869-5. Epub 2008 Sep 17.
citation: Kortebein P, Symons TB, Ferrando A, Paddon-Jones D, Ronsen O, Protas E, Conger S, Lombeida J, Wolfe R, Evans WJ. Functional impact of 10 days of bed rest in healthy older adults. J Gerontol A Biol Sci Med Sci. 2008 Oct;63(10):1076-81. doi: 10.1093/gerona/63.10.1076.
citation: Aguilar-Farias N, Brown WJ, Peeters GM. ActiGraph GT3X+ cut-points for identifying sedentary behaviour in older adults in free-living environments. J Sci Med Sport. 2014 May;17(3):293-9. doi: 10.1016/j.jsams.2013.07.002. Epub 2013 Aug 8.
citation: Egerton T, Brauer SG, Cresswell AG. Fatigue after physical activity in healthy and balance-impaired elderly. J Aging Phys Act. 2009 Jan;17(1):89-105. doi: 10.1123/japa.17.1.89.
citation: Tremblay MS, Carson V, Chaput JP, Connor Gorber S, Dinh T, Duggan M, Faulkner G, Gray CE, Gruber R, Janson K, Janssen I, Katzmarzyk PT, Kho ME, Latimer-Cheung AE, LeBlanc C, Okely AD, Olds T, Pate RR, Phillips A, Poitras VJ, Rodenburg S, Sampson M, Saunders TJ, Stone JA, Stratton G, Weiss SK, Zehr L. Canadian 24-Hour Movement Guidelines for Children and Youth: An Integration of Physical Activity, Sedentary Behaviour, and Sleep. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S311-27. doi: 10.1139/apnm-2016-0151.
citation: Shadmi E, Zisberg A. In-hospital mobility and length of stay. Arch Intern Med. 2011 Jul 25;171(14):1298; author reply 1298-9. doi: 10.1001/archinternmed.2011.321. No abstract available.
citation: Brown CJ, Williams BR, Woodby LL, Davis LL, Allman RM. Barriers to mobility during hospitalization from the perspectives of older patients and their nurses and physicians. J Hosp Med. 2007 Sep;2(5):305-13. doi: 10.1002/jhm.209.
citation: Liu B, Moore JE, Almaawiy U, Chan WH, Khan S, Ewusie J, Hamid JS, Straus SE; MOVE ON Collaboration. Outcomes of Mobilisation of Vulnerable Elders in Ontario (MOVE ON): a multisite interrupted time series evaluation of an implementation intervention to increase patient mobilisation. Age Ageing. 2018 Jan 1;47(1):112-119. doi: 10.1093/ageing/afx128.
citation: Hartley PJ, Keevil VL, Alushi L, Charles RL, Conroy EB, Costello PM, Dixon B, Dolinska-Grzybek AM, Vajda D, Romero-Ortuno R. Earlier Physical Therapy Input Is Associated With a Reduced Length of Hospital Stay and Reduced Care Needs on Discharge in Frail Older Inpatients: An Observational Study. J Geriatr Phys Ther. 2019 Apr/Jun;42(2):E7-E14. doi: 10.1519/JPT.0000000000000134.
citation: Hartley P, Adamson J, Cunningham C, Embleton G, Romero-Ortuno R. Higher Physiotherapy Frequency Is Associated with Shorter Length of Stay and Greater Functional Recovery in Hospitalized Frail Older Adults: A Retrospective Observational Study. J Frailty Aging. 2016;5(2):121-5. doi: 10.14283/jfa.2016.95.
citation: Eklund K, Wilhelmson K, Gustafsson H, Landahl S, Dahlin-Ivanoff S. One-year outcome of frailty indicators and activities of daily living following the randomised controlled trial: "Continuum of care for frail older people". BMC Geriatr. 2013 Jul 22;13:76. doi: 10.1186/1471-2318-13-76.
citation: Mitnitski AB, Mogilner AJ, Rockwood K. Accumulation of deficits as a proxy measure of aging. ScientificWorldJournal. 2001 Aug 8;1:323-36. doi: 10.1100/tsw.2001.58.
citation: de Vries NM, Staal JB, van Ravensberg CD, Hobbelen JS, Olde Rikkert MG, Nijhuis-van der Sanden MW. Outcome instruments to measure frailty: a systematic review. Ageing Res Rev. 2011 Jan;10(1):104-14. doi: 10.1016/j.arr.2010.09.001. Epub 2010 Sep 17.
citation: Theou O, O'Connell MD, King-Kallimanis BL, O'Halloran AM, Rockwood K, Kenny RA. Measuring frailty using self-report and test-based health measures. Age Ageing. 2015 May;44(3):471-7. doi: 10.1093/ageing/afv010. Epub 2015 Feb 16.
citation: Hubbard RE, Peel NM, Samanta M, Gray LC, Mitnitski A, Rockwood K. Frailty status at admission to hospital predicts multiple adverse outcomes. Age Ageing. 2017 Sep 1;46(5):801-806. doi: 10.1093/ageing/afx081.
citation: Laporte M, Keller HH, Payette H, Allard JP, Duerksen DR, Bernier P, Jeejeebhoy K, Gramlich L, Davidson B, Vesnaver E, Teterina A. Validity and reliability of the new Canadian Nutrition Screening Tool in the 'real-world' hospital setting. Eur J Clin Nutr. 2015 May;69(5):558-64. doi: 10.1038/ejcn.2014.270. Epub 2014 Dec 17.
citation: Lord S, Chastin SF, McInnes L, Little L, Briggs P, Rochester L. Exploring patterns of daily physical and sedentary behaviour in community-dwelling older adults. Age Ageing. 2011 Mar;40(2):205-10. doi: 10.1093/ageing/afq166. Epub 2011 Jan 14.
citation: Cowie A, Thow MK, Granat MH, Mitchell SL. A comparison of home and hospital-based exercise training in heart failure: immediate and long-term effects upon physical activity level. Eur J Cardiovasc Prev Rehabil. 2011 Apr;18(2):158-66. doi: 10.1177/1741826710389389. Epub 2011 Feb 18.
citation: Chan CS, Slaughter SE, Jones CA, Ickert C, Wagg AS. Measuring Activity Performance of Older Adults Using the activPAL: A Rapid Review. Healthcare (Basel). 2017 Dec 13;5(4):94. doi: 10.3390/healthcare5040094.
citation: Hubbard RE, Eeles EM, Rockwood MR, Fallah N, Ross E, Mitnitski A, Rockwood K. Assessing balance and mobility to track illness and recovery in older inpatients. J Gen Intern Med. 2011 Dec;26(12):1471-8. doi: 10.1007/s11606-011-1821-7. Epub 2011 Aug 16.
citation: Theou O, Stathokostas L, Roland KP, Jakobi JM, Patterson C, Vandervoort AA, Jones GR. The effectiveness of exercise interventions for the management of frailty: a systematic review. J Aging Res. 2011 Apr 4;2011:569194. doi: 10.4061/2011/569194.