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Michelle Kho, PT, PhDon behalf of the CYCLE Investigators
April 23, 2017
Using activity to address frailty:E-CYCLE In-bed cycling
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
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
1. WHAT ARE THE EFFECTS OF CRITICAL ILLNESS ON THE ELDERLY?
• Elderly receiving more life support interventions• Mechanical
ventilation• Vasopressors• Renal
replacement• Improved survival
LeRolle et al., Crit Care Med 2010;38(1):59-64.
Brummel et al., Crit Care Med. 2015; 43:1265–1275.
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%
Disability is common in elderly who survive critical care
Towards RECOVER:Prospective 1-year follow-up of 391 ICU survivors
Clinical
Course
ICU
Discharge
ICU
Admission
Setting: 10 Canadian medical-surgical ICUsPopulation: Adult ICU survivors MV >=7 d
Outcomes:• Functional Independence Measure (FIM)• Impact of Event Scale (PTSD)• Beck Depression Inventory
7 days 3 months 6 months 12 months
Herridge et al, AJRCCM. 2016. In press. Available online March 2016.
• Hip & shoulder girdle weakness; poor coordination, gait, & balance• 40% able to walk @ 7 days post-ICU
• ~ 1 in 5 reported important symptoms of PTSD• ~ 1 in 5 reported moderate to severe depressive symptoms
Median (IQR) ICU LOS: 16 (11-27); Hospital LOS: 49
Herridge et al, AJRCCM. 2016. In press. Available online March 2016.
FIM Score 126 >60 50 <40 18
Totally independent
Modified Independence
ModerateAssistance
Max to Total Assistance
Totally dependent
• ICU LOS and age predicted FIM @ 7 days
• FIM @ 7 days predicted 1 year recovery
No impact of Admission Dxor APACHE II score
2. HOW CAN ACTIVITY ADDRESS FRAILTY IN THE CRITICALLY ILL ELDERLY?
Continuum of physical activity
Bedrest Completely Passive
Completely Active
Increasing physical activity and patient engagement in rehab
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 20102
• Different from physiology of exercise
• NOT absence of meeting physical activity guidelines
1Appl Physiol Nutr Metab. 2012. 37: 540-42.2Diabetologica. 2012. 55:2895-2905.
Continuum of physical activity
https://sites.google.com/site/compendiumofphysicalactivities/
1.0
Sleeping
1.5
Sitting
< 1.5 METS
2.0Grooming
2.5Dressing
9.8Running
60 min
10K
10.0Hockey
Soccer
3.5Descending
stairs
8.0Synchro
Swimming
23.0Running
27 min
10K
> 1.5 METS
Dunstan et al., European Endocrinology. 2010. 6(1):19-23.
3. HOW DOES E-CYCLE ADDRESS FRAILTY IN THE CRITICALLY ILL ELDERLY?
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 trials1
1Cooke et al., Crit Care Med 2010;38(6):1450-1457.
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
• RCT: In-bed cycling started ICU day 14 improved 6-minute walk test distance at hospital discharge
• Question: Can we initiate in-bed cycling with patients earlier in their ICU stay, and will it improve patient outcomes?
Crit Care Med. 2009. 37(9): 2499-2505.
Lancet. 2009. 373: 1874-1882.
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?
CYCLE: Critical Care Cycling to Improve Lower Extremity Strength
CYCLEPreparation phase
Survey development: pt, family, clinician satisfaction with rehabilitation
Retrospective chart
audit ✔ JCC 2015
CYCLE-R
Systematic Review
Uni-CYCLE
ICAN Rehab
TryCYCLE:Phase II open label study
1 center, 33 pt prospective cohort•Design the intervention; select outcomes; assess fidelity, safety, satisfaction, and acceptability ✔PLoS One 2016
CYCLE RCT:Phase III randomized trial
Multicenter RCT
BICYCLE
BehaviouralIntervention for Knowledge Translation
CYCLE$
Economic evaluation
7 center, 66 pt pilot RCT• Feasibility✔ BMJ Open 2016 (protocol paper)
CYCLE RCT:Phase II pilot randomized trial
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
Example of in-bed cycling
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
Awake
Outcomes #1 (short)
RCT Study Schema
30 min cycling + Routine PT or Routine PT
Clinical Course
Study Outcome Assessments
ICU Admission
Routine PT
Study Entry ≤4 d MV
Intubated
ICU Discharge
Outcomes #2
Hospital Discharge
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: NCT02377830
RESEARCH QUESTION:
In medical-surgical ICU patients, is it safe and feasibleto 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):e0167561.
TryCYCLE - Patients’ Cycling DistancesMedian 5 (3, 8) sessions/ patient
Per session, km 1.0 (0.9, 2.0)
Per patient, km 8.7 (5.0, 14.0)
0
5
10
15
20
25
30
35
40
45
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Total Distance(Km)
Age ≥ 65
Age ≤ 65
RESEARCH QUESTION:
Is it feasible to enroll newly mechanically ventilated elderly adults in a multi-centre pilot RCT of early in-bed cycling plus routine physiotherapy versus routine physiotherapy alone to inform a larger RCT?
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
PRELIMINARY RESULTS
Patients Enrolled Over Time66
0
10
20
30
40
50
60
70
# o
f P
atie
nts
Month
Monthly Total
Overall
As of June 23rd, 2016
20162015
JCC & HGH
TGH
SMH
SJH
OGH & LHS
SJH= St Joseph’s HospitalJCC= Juravinski Cancer CentreHGH= Hamilton General HospitalTGH= Toronto General HospitalSMH= St. Michael’s HospitalOGH= Ottawa General HospitalLHS= London Health Sciences
66
0
10
20
30
40
50
60
70
SJH JCC HGH TGH SMH OGH LHS
# o
f P
atie
nts
Site
≥ 65 yrs
< 65 yrs
Cumulative Totals
Patients Enrolled by Site and Age
SJH= St Joseph’s HospitalJCC= Juravinski Cancer CentreHGH= Hamilton General HospitalTGH= Toronto General HospitalSMH= St. Michael’s HospitalOGH= Ottawa General HospitalLHS= London Health Sciences
As of June 23rd, 2016
Screening Milestone Total
Patients screened 867
Patients excluded 605
Patients eligible 263
Patients eligible not randomized 197
Total number of patients enrolled 66
Overall Screening Synopsis
Data as of June 23rd; Analysis as of August 26th, 2016
77% of eligible
patients are not
randomized
Overall Screening- Reasons Eligible Not Randomized
12
0 50 100
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
# of Patients (n = 197)Reason
Overall Consent Rate = 85%
Data as of June 23rd, 2016Analysis as of August 26th, 2016
E-CYCLE Consent Rate = 82.5%
Overall Screening- Reasons Eligible Not Randomized
91
29
15
14
0 50 100
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
# of Patients (n = 197)Reason
57% of all eligible patients are not
randomized due to PT resources
35% of ENR due to CYCLE patients on
study
Data as of June 23rd, 2016Analysis as of August 26th, 2016
Characteristics of included patientsE-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%)
Characteristics of included patientsE-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%)
CYCLE Pilot RCT Feasibility Outcomes
R
Early cycling + routine PTN=36
Routine PTN=30
7 Medical/ Surgical ICUs
N=66
79.2% (146/185)
86.4% (38/44)
81.6% (31/38)
2. Cycling delivery >80%
3. PFIT-s hospital d/c>80%
4. PFIT-s blinded>80%
• 2/36 patients did not receive any cycling• Median [IQR] 3 [2 to 5] days from ICU admit to 1st bike• 1/146 cycling sessions stopped due to persistent
tachycardiaPreliminary data.
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
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.
https://physiotherapy.ca/blog/early-bed-cycling-icu-perspectives-frontline-pt
We were able to do it because we learned to be a stronger physiotherapy team.
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
Parting thought:• How can we
meaningfully engage frontline healthcare providers and hospital decision makers in critical care research for frail Canadians?
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
RCT Team Members
Physiotherapists/ Physiotherapist Assistants; RCs; RAsSt. 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
RCT Team Members