Using activity to address frailty: E-CYCLE In-bed cycling

Transcription

1 Using activity to address frailty: E-CYCLE In-bed cycling Michelle Kho, PT, PhD on behalf of the CYCLE Investigators April 23, 2017

2 Acknowledgements Funding Canadian Frailty Network Canada Research Chairs Canada Foundation for Innovation Ontario Research Fund Research Infrastructure Program Canadian Respiratory Research Network Emerging Research Leaders Initiative Ontario Thoracic Society Canadian Institutes for Health Research Equipment loan Restorative Therapies for bike loans at Toronto General Hospital and London Health Sciences

3 Presentation Outline 1. Understand the effects of critical illness on the elderly 2. Describe how activity can address frailty in the critically ill elderly 3. Describe how E-CYCLE addresses frailty in the critically ill elderly

4 1. WHAT ARE THE EFFECTS OF CRITICAL ILLNESS ON THE ELDERLY?

5 Elderly receiving more life support interventions Mechanical ventilation Vasopressors Renal replacement Improved survival LeRolle et al., Crit Care Med 2010;38(1):59-64.

6 Disability is common in elderly who survive critical care Disability < 3 months > 6 months Mobility 14% - 87% Activities of daily living (prevalence) 33% - 58% 12% - 97% Instrumental activities of daily living 22% - 45% Cognitive impairment 56% Brummel et al., Crit Care Med. 2015; 43:

7 Towards RECOVER: Prospective 1-year follow-up of 391 ICU survivors Setting: 10 Canadian medical-surgical ICUs Population: Adult ICU survivors MV >=7 d ICU Admission ICU Discharge Outcomes: Functional Independence Measure (FIM) Impact of Event Scale (PTSD) Beck Depression Inventory Clinical Course Median (IQR) ICU LOS: 16 (11-27); Hospital LOS: 49 7 days 3 months 6 months 12 months Hip & shoulder girdle weakness; poor coordination, gait, & balance 40% able to 7 days post-icu ~ 1 in 5 reported important symptoms of PTSD ~ 1 in 5 reported moderate to severe depressive symptoms Herridge et al, AJRCCM In press. Available online March 2016.

8 No impact of Admission Dx or APACHE II score ICU LOS and age predicted 7 days 7 days predicted 1 year recovery FIM Score 126 >60 50 <40 18 Totally independent Modified Independence Moderate Assistance Max to Total Assistance Totally dependent Herridge et al, AJRCCM In press. Available online March 2016.

9 2. HOW CAN ACTIVITY ADDRESS FRAILTY IN THE CRITICALLY ILL ELDERLY?

10 Continuum of physical activity Bedrest Completely Passive Completely Active Increasing physical activity and patient engagement in rehab

11 What is Sedentary Behaviour? Any waking sitting or lying behaviour with low energy expenditure <1.5 metabolic equivalents (METs) 1 Emerging science in exercise physiology New MESH term Different from physiology of exercise NOT absence of meeting physical activity guidelines 1 Appl Physiol Nutr Metab : Diabetologica :

12 Continuum of physical activity < 1.5 METS > 1.5 METS 1.0 Sleeping 1.5 Sitting 2.0 Grooming 2.5 Dressing 3.5 Descending stairs 8.0 Synchro Swimming 9.8 Running 60 min 10K 10.0 Hockey Soccer 23.0 Running 27 min 10K

13 Dunstan et al., European Endocrinology (1):19-23.

14 3. HOW DOES E-CYCLE ADDRESS FRAILTY IN THE CRITICALLY ILL ELDERLY?

15 Some considerations Is it feasible to conduct early rehabilitation with critically ill, elderly patients? Few rehabilitation studies in critically ill, elderly patients Elderly patients underrepresented in critical care clinical trials 1 1 Cooke et al., Crit Care Med 2010;38(6):

16 Rationale for E-CYCLE RCT: PT and OT started within 1.5 days of intubation improves independence at hospital discharge Main difference: 19.2 minutes/ day during MV Lancet : RCT: In-bed cycling started ICU day 14 improved 6-minute walk test distance at hospital discharge Crit Care Med (9): Question: Can we initiate in-bed cycling with patients earlier in their ICU stay, and will it improve patient outcomes?

17 CYCLE: Critical Care Cycling to Improve Lower Extremity Strength Research Question: In medical-surgical ICU patients, does 30 minutes of in-bed cycling and routine PT started within the first 4 days of mechanical ventilation, compared to routine PT improve patient function at hospital discharge?

18 CYCLE: Critical Care Cycling to Improve Lower Extremity Strength CYCLE Preparation phase TryCYCLE: Phase II open label study CYCLE RCT: Phase II pilot randomized trial CYCLE RCT: Phase III randomized trial ICAN Rehab Survey development: pt, family, clinician satisfaction with rehabilitation CYCLE-R Systematic Review Uni-CYCLE 1 center, 33 pt prospective cohort Design the intervention; select outcomes; assess fidelity, safety, satisfaction, and acceptability PLoS One center, 66 pt pilot RCT Feasibility BMJ Open 2016 (protocol paper) Multicenter RCT CYCLE$ Economic evaluation BICYCLE Behavioural Intervention for Knowledge Translation Retrospective chart audit JCC 2015

19 CYCLE Research Program Philosophy Integrated knowledge translation approach Incremental and systematic Safety & Feasibility Consent, intervention delivery, outcome measures Scalability among other centres Pilot RCT before full RCT In collaboration with the Canadian Critical Care Trials Group

20 Example of in-bed cycling

21 CYCLE inclusion criteria Adult patient 18 years old Invasively mechanically ventilated 4 days Expected additional 2 day ICU stay Walked independently pre-hospital ICU length of stay 7 days

22 RCT Study Schema ICU Admission Study Entry 4 d MV Awake ICU Discharge Hospital Discharge Clinical Course Intubated 30 min cycling + Routine PT or Routine PT Routine PT Study Outcome Assessments Outcomes #1 (short) Outcomes #2 Outcomes #3 Intervention delivered by front-line physiotherapists in 7 Canadian centers Randomized intervention 5d/ wk until ICU d/c or 28 days Cycling patients -> d/c cycling if patient can march on the spot x 2 days Trial Registration: NCT

23 RESEARCH QUESTION: In medical-surgical ICU patients, is it safe and feasible to initiate 30 minutes of in-bed leg cycling within 4 days of starting mechanical ventilation and through the ICU stay? PLoS One. 2016;11(12):e

24 TryCYCLE - Patients Cycling Distances Median 5 (3, 8) sessions/ patient Per session, km 1.0 (0.9, 2.0) Per patient, km 8.7 (5.0, 14.0) 30 Age 65 Age 65 Total Distance (Km)

25 RESEARCH QUESTION: Is it feasible to enroll newly mechanically ventilated elderly adults in a multi-centre pilot RCT of early inbed cycling plus routine physiotherapy versus routine physiotherapy alone to inform a larger RCT?

26 E-CYCLE Pilot RCT Feasibility Outcomes 1. Accrual: Following orientation, the overall average accrual rate will be 3 pts/ month (1 pt/month/ site) 2. Protocol violations: The cycling protocol can be implemented with <20% protocol violations 3. Outcome Measures: >80% of outcomes will be measured as scheduled 4. Blinded Outcome Assessment: >80% of outcomes at hospital discharge will be assessed by personnel blinded to group allocation

27 PRELIMINARY RESULTS

28 # of Patients Patients Enrolled Over Time SJH= St Joseph s Hospital JCC= Juravinski Cancer Centre HGH= Hamilton General Hospital TGH= Toronto General Hospital SMH= St. Michael s Hospital OGH= Ottawa General Hospital LHS= London Health Sciences Monthly Total Overall JCC & HGH TGH SMH OGH & LHS SJH Month 2016 As of June 23 rd, 2016

29 # of Patients Patients Enrolled by Site and Age SJH= St Joseph s Hospital JCC= Juravinski Cancer Centre HGH= Hamilton General Hospital TGH= Toronto General Hospital SMH= St. Michael s Hospital OGH= Ottawa General Hospital LHS= London Health Sciences 65 yrs < 65 yrs Cumulative Totals SJH JCC HGH TGH SMH OGH LHS Site As of June 23 rd, 2016

30 Overall Screening Synopsis Screening Milestone Total Patients screened 867 Patients excluded 605 Patients eligible % of eligible Patients eligible not randomized patients are 197 not randomized Total number of patients enrolled 66 Data as of June 23 rd ; Analysis as of August 26 th, 2016

31 Overall Screening- Reasons Eligible Not Randomized Reason # of Patients (n = 197) PT resources- CYCLE pts PT resources- Study on Hold Other No PT available PT resources- No CYCLE pts Patient or SDM declines consent Unable to consent/no SDM Previously enrolled No RC available Physician declines consent 12 Overall Consent Rate = 85% E-CYCLE Consent Rate = 82.5% Data as of June 23 rd, 2016 Analysis as of August 26 th, 2016

32 Overall Screening- Reasons Eligible Not Randomized Reason # of Patients (n = 197) PT resources- CYCLE pts 91 PT resources- Study on Hold Other No PT available PT resources- No CYCLE pts % of all eligible patients are not randomized due to PT resources Patient or SDM declines consent Unable to consent/no SDM Previously enrolled No RC available 35% of ENR due to CYCLE patients on study Physician declines consent Data as of June 23 rd, 2016 Analysis as of August 26 th, 2016

33 Characteristics of included patients E-CYCLE Characteristic N = 33 patients Female, n (%) 12 (36.4%) Age, mean (SD) years 74.6 (7.4) APACHE II Score, mean (SD) 25.8 (8.0) Medical admission diagnosis, n (%) 27 (81.8%) ICU length of stay, median [IQR], days 11.0 [9 23] Hospital length of stay, median [IQR], days 25 [18 36] ICU mortality, n (%) 10 (30.3%) Hospital mortality, n (%) 11 (33.3%)

34 Characteristics of included patients Characteristic E-CYCLE N = 33 patients Female, n (%) 12 (36.4%) Age, mean (SD) years 74.6 (7.4) APACHE II Score, mean (SD) 25.8 (8.0) Medical admission diagnosis, n (%) 27 (81.8%) ICU length of stay, median [IQR], days 11.0 [9 23] Hospital length of stay, median [IQR], days 25 [18 36] ICU mortality, n (%) 10 (30.3%) Hospital mortality, n (%) 11 (33.3%)

35 CYCLE Pilot RCT Feasibility Outcomes 7 Medical/ Surgical ICUs R N=66 Early cycling + routine PT N=36 Routine PT N=30 2. Cycling delivery >80% 79.2% (146/185) 3. PFIT-s hospital d/c >80% 86.4% (38/44) 4. PFIT-s blinded >80% 81.6% (31/38) 2/36 patients did not receive any cycling Median [IQR] 3 [2 to 5] days from ICU admit to 1 st bike 1/146 cycling sessions stopped due to persistent tachycardia Preliminary data.

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37 Future Opportunities for E-CYCLE Clinical: Physiotherapist capacity to provide intervention Program management vs. department-based models CYCLE Vanguard Optimize trial design & involvement of clinical PTs Equipment infrastructure, clinician education Patient-centred: Who benefits most? Interdisciplinary: Cycling is one tool Scaling: International collaborators

38 But the biggest question was: could we do this research study? Our staffing was changing as people were going on maternity leaves and others coming back. The ICU was busy, and there were other demands on our time. Setting up a machine and running it for half an hour, then taking it down seemed like it would take over our day. We were able to do it because we learned to be a stronger physiotherapy team.

39 Presentation Outline 1. Understand the effects of critical illness on the elderly 2. Describe how activity can address frailty in the critically ill elderly 3. Describe how E-CYCLE addresses frailty in the critically ill elderly

40 Parting thought: How can we meaningfully engage frontline healthcare providers and hospital decision makers in critical care research for frail Canadians?

41 RCT Team Members Investigators (Alphabetical) Dr. Ian Ball, Western Dr. Karen Burns, St. Mike s Dr. Deborah Cook, McMaster/ SJH (mentor) Dr. Alison Fox-Robichaud, McMaster/ Hamilton General Dr. Jan Friedrich, St. Mike s Dr. Margaret Herridge, Toronto General Dr. Tim Karachi, McMaster/ Juravinski Dr. Karen Koo, Western/ Swedish Healthcare Mr. Vince Lo, Toronto General Dr. Sunita Mathur, Toronto General/ U Toronto Dr. Marina Mourtzakis, U Waterloo Dr. Joe Pellizzari, McMaster/ SJH Mr. Tom Piraino, McMaster/ SJH Dr. Bram Rochwerg, McMaster, Juravinski Dr. Jill Rudkowski, McMaster/ SJH Dr. Andrew Seely, U Ottawa/ Ottawa General Dr. Jean-Eric Tarride, McMaster Methods Centre (Hamilton, ON) Ms. France Clarke, McMaster/ SJH Dr. Aileen Costigan, SJH Mr. Alex Molloy, SJH Ms. Janelle Unger, U Toronto Ms. Devin McCaskell, U Toronto/ SJH Mr. Mike Ciancone, McMaster/ SJH

42 RCT Team Members Physiotherapists/ Physiotherapist Assistants; RCs; RAs St. Joseph s Healthcare: Daana Ajami, Laura Camposilvan, Magda McCaughan, Kristy Obrovac, Christina Murphy, Wendy Perry, Diana Hatzoglou, Miranda Prince, Bashir Versi; RCs France Clarke, Aileen Costigan, Alex Molloy Hamilton Health Sciences Juravinski: Leigh Ann Niven, Tania Brittain, Jessica Temesy, Andrea Galli, Chris Farley, Shivaun Davidson, Helen Bishop, Shannon Earl, Chelsea Hale, Gillian Manson; RC Tina Millen Hamilton Health Sciences General: Ashley Eves, Annie Newman, Judi Rajczak, Julie Reid, Elise Loreto, Sarah Lohonyai, Jennifer Duley, Sue Mahler, Matt McCaffrey, Jessica Pilon- Bignell; RC Ellen McDonald Toronto General: Vince Lo, Sunita Mathur, Gary Beauchamp, Anne-Marie Bourgeois, Nathalie Côté, Sherry Harburn, Adriane Lachmaniuk, Megan Hudson, Sophie Mendo, Teresa Torres; RC Andrea Matte; RAs Jaimie Archer, Daniel Chen, Cristian Urrea, Lia Stenyk London Health Sciences: Kristen Abercombie, Jennifer Curry, Erin Blackwell-Knowles, Tania Larsen, Jennifer Jackson; RC Eileen Campbell; RA Rebecca Rondinelli St. Michael s Hospital: Deanna Feltracco, Christine Leger, Sarah Brown, Diana Horobetz, Verity Tulloch, Anna Michalski, Natalia Zapata; RCs Orla Smith, Kurtis Salway, Gyan Sandhu Ottawa General: Rachel Goard, Josee Lamontagne, Michelle Cummings, Sarah (Sal) Patten; RCs Rebecca Porteous, Heather Langlois, Irene Watpool, Brigette Gomes, Shelley Acres