The Impact of Lower Extremity Weight-Bearing Leg Exercise During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane Oxygenation
Phase: NA
Conditions: Refractory Respiratory Failure
Sponsor: University of Minnesota

PROTOCOL TITLE: The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane 
Oxygenation (ECMO) 
VERSION DATE: 11/28/16 
 
Page 1 of 9 
Revised: 1/19/2018 
 
 
 
PROTOCOL COVER PAGE 
 
 
 
 
Protocol Title 
The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing 
Extracorporeal Membrane Oxygenation (ECMO) 
Principal 
Investigator/Faculty 
Advisor 
Name: Amanda LaLonde 
Department: Rehabilitation Medicine 
Telephone Number: 612.626.4691 
Email Address: lalonde@umn.edu 
Student 
Investigator 
Name: n/a 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific 
Assessment 
Not required, Minimial Risk Study 
ClinicalTrials.gov 
NCT03135210 
IND/IDE Holder 
N/A. 
Investigational Drug 
Services # (if 
applicable) 
N/A. 
Version 
Number/Date: 
11/28/16 
 

PROTOCOL TITLE: The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane 
Oxygenation (ECMO) 
VERSION DATE: 11/28/16 
 
Page 2 of 9 
Revised: 1/19/2018 
REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane 
Oxygenation (ECMO) 
VERSION DATE: 11/28/16 
 
Page 3 of 9 
Revised: 1/19/2018 
Table of Contents 
 
1.0 
Study Intervention(s)/Investigational Agent(s)....................................................... 5 
2.0 
Local Procedures Involved and Local Requirements ............................................. 5 
3.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ..................... 5 
4.0 
Data and Specimen Banking ................................................................................... 5 
5.0 
Sharing of Results with Participants ....................................................................... 6 
6.0 
Local Study Population ........................................................................................... 6 
7.0 
Vulnerable Populations ........................................................................................... 6 
8.0 
Local Number of Participants ................................................................................. 7 
9.0 
Local Recruitment Methods .................................................................................... 7 
10.0 
Withdrawal of Participants ..................................................................................... 8 
11.0 
Risks to Participants ................................................................................................ 8 
12.0 
Potential Benefits to Participants ............................................................................ 8 
13.0 
Confidentiality ........................................................................................................ 8 
14.0 
Provisions to Protect the Privacy Interests of Participants ..................................... 8 
15.0 
Compensation for Research-Related Injury ............................................................ 8 
16.0 
Consent Process ...................................................................................................... 8 
17.0 
Setting ..................................................................................................................... 9 
18.0 
Multi-Site Research: ............................................................................................... 9 
19.0 
Resources Available................................................................................................ 9 
 

PROTOCOL TITLE: The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane 
Oxygenation (ECMO) 
VERSION DATE: 11/28/16 
 
Page 4 of 9 
Revised: 1/19/2018 
ABBREVIATIONS/DEFINITIONS 
 
ECMO: Extracorporeal Membrane Oxygenation 
 
PT: Physical Therapy 
 
 

PROTOCOL TITLE: The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane 
Oxygenation (ECMO) 
VERSION DATE: 11/28/16 
 
Page 5 of 9 
Revised: 1/19/2018 
1.0 
Study Intervention(s)/Investigational Agent(s) 
1.1 Description:  
We are conducting this study to explore the impact of closed-chain leg 
exercise in individuals undergoing ECMO. Closed-chain leg exercise will be 
completed on the MOVEO XP Platform System. Drug/Device Handling:  
1.2 Biosafety: N/A 
1.3 Stem Cells: N/A 
 
2.0 
Local Procedures Involved and Local Requirements 
2.1 Local Procedures: N/A 
2.2 Individually Identifiable Health Information: De-identified participant data 
will be used in the data analysis process. Individual data will be collected 
during scheduled physical therapy sessions and therefore a part of the 
subject’s medical record regardless of study participation. As with any 
medical record information, individuals can request medical record access, 
in this case, all subjects will be at UMMC Fairview and will need to follow 
the process outlined by Fairview for such a request.  
2.3 Use of radiation: N/A 
2.4 Use of Center for Magnetic Resonance Research:N/A 
3.0 
Provisions to Monitor the Data to Ensure the Safety of Participants 
3.1 Protecting Privacy: Subjects are working with physical therapy regardless of 
enrollment in this study. At any time they can request to stop either therapy 
or the study. Their medical records are secured in the Fairview system. Data 
extracted for study purposes is accessed by the primary therapist and de-
identified prior to input into REDcap system. 
3.2 Data Integrity Monitoring. N/A 
3.3 Data Safety Monitoring. N/A 
 
4.0 
Data and Specimen Banking 
4.1 Storage and Access: Study personnel who have completed HIPAA, CITI, 
and other data management training through the University of Minnesota 
Medical Center, Fairview and the University of Minnesota will be 
responsible for the collection, management, and analysis of study data.  
 
Participants will be randomized to groups through a randomization service 
prior to study initiation. All participants will be assigned a subject number 
that will be stored on a computer at the University of Minnesota, which is 

PROTOCOL TITLE: The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane 
Oxygenation (ECMO) 
VERSION DATE: 11/28/16 
 
Page 6 of 9 
Revised: 1/19/2018 
password protected. Data collected from participant’s medical records will 
be managed exclusively by the primary therapist and the PI, and stored in a 
password protected data management system through Research Electronic 
Data Capture (REDCap), available at the University of Minnesota. 
 
In accordance with regulations, participant records will be stored for a 
minimum of three years following completion of the study. After the stated 
timeframe and if data is no longer needed, records will be destroyed.  
4.2 Data: No future use is intended, data is not banked for additional analysis. 
4.3 Release/Sharing: Subjects are working with physical therapy regardless of 
enrollment in this study. At any time they can request to stop either therapy 
or the study. Their medical records are secured in the Fairview system. Data 
extracted for study purposes is accessed by the primary therapist and de-
identified prior to input into REDcap system. 
5.0 
Sharing of Results with Participants  
Please reference main protocol, section 19.0, page 14 of 16 
 
6.0 
Local Study Population 
Please reference criteria found in main protocol section 9.0, page 11 of 16 
 
7.0 
Vulnerable Populations 
7.1 Vulnerable Populations:  
☐ Children 
☐ Pregnant women/Fetuses/Neonates 
☐ Prisoners 
☐ Adults lacking capacity to consent and/or adults with diminished 
capacity to consent, including, but not limited to, those with acute 
medical conditions, psychiatric disorders, neurologic disorders, 
developmental disorders, and behavioral disorders 
☐ Approached for participation in research during a stressful situation such 
as emergency room setting, childbirth (labor), etc. 
☐ Disadvantaged in the distribution of social goods and services such as 
income, housing, or healthcare 
☐ Serious health condition for which there are no satisfactory standard 
treatments 
☐ Fear of negative consequences for not participating in the research (e.g. 
institutionalization, deportation, disclosure of stigmatizing behavior) 
☐ Any other circumstance/dynamic that could increase vulnerability to 
coercion or exploitation that might influence consent to research or 
decision to continue in research 

PROTOCOL TITLE: The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane 
Oxygenation (ECMO) 
VERSION DATE: 11/28/16 
 
Page 7 of 9 
Revised: 1/19/2018 
☐ Undervalued or disenfranchised social group 
☐ Members of the military 
☐ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 
☐ Students of the researcher 
☒ None of the above 
7.2 Additional Safeguards: N/A  
8.0 
Local Number of Participants 
8.1 Local Number of Participants to be Consented:  
Local Number of Participants to be Consented: This initial pilot study will be 
conducted at the University of Minnesota Medical Center (UMMC), Fairview, 
and will involve 10 participants in each of the two groups (A and B). To account 
for attrition, 24 total subjects will be recruited; 12 per group. Approximately 3-5 
patients are admitted to UMMC each month who are undergoing ECMO and 
could be considered for study inclusion. The study will be conducted with a goal 
endpoint of 1-year. 
9.0 
Local Recruitment Methods 
9.1 Recruitment Methods: Recruitment Process: Individuals consented are 
those already being seen by physical therapists at UMMC, Fairview as a 
part of standard practice. Physical therapy delivery will either involve or not 
involve the Moveo XP platform system, if individuals consent to participate 
and based on Group assignment (A or B). 
9.2 Identification of Potential Participants: Standard practice includes a 
physician order for inpatient physical therapy for all individuals undergoing 
ECMO, as well as initial medical sedation. Most of those receiving ECMO 
are at least partially medically sedated at the time of physical therapy 
initiation. Only physical therapists who are specialty-trained ICU therapists 
and who are a part of this project will be working with this group of 
patients. 
 
Any individual who meets inclusion criteria will be considered for 
participation, pending their ability to follow 3/3 one-step commands, as is 
outlined in the ECMO Mobility Protocol listed previously. Patients will be 
able to self-consent once sedation is reduced. After consent, individuals will 
be placed into either Group A or B and progress through the protocol. Group 
assignments will be determined based on 24 subjects, with the number 24 
put into a random letter sequence generator prior to subject recruitment.  
 

PROTOCOL TITLE: The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane 
Oxygenation (ECMO) 
VERSION DATE: 11/28/16 
 
Page 8 of 9 
Revised: 1/19/2018 
 
Physical therapists working at Fairview have legitimate access to 
records as a part of their employment. The off-site PI will only have 
access to de-identified data, not medical records. 
 
The physical therapist assigned to a given patient will initiate contact 
with patients (potential subjects). 
9.3 Recruitment Materials: No recruitment materials are needed. 
9.4 Payment: There is no funding or payment associated with any part of this 
study. 
10.0 Withdrawal of Participants 
Please reference main protocol, section 13.0 pages 12-13 of 16 
 
11.0 Risks to Participants 
Please reference main protocol, section 14.0, page 13 of 16 
 
12.0 Potential Benefits to Participants 
Please reference main protocol, section 15.0 page 13 of 16 
 
13.0 Confidentiality 
Please reference page 14 of main protocol, section 17.0 
 
14.0 Provisions to Protect the Privacy Interests of Participants 
Please see page 14 of main protocol, section 19.0 
 
15.0 Compensation for Research-Related Injury 
15.1 Compensation for Research-Related Injury: N/A 
15.2 Contract Language: N/A 
16.0 Consent Process 
16.1 Consent Process (when consent will be obtained): Once subjects are 
removed from sedation and able to follow 3/3 one-step commands.  
 
Consent will occur in the hospital room of the subject. There will be 
no waiting period between initial consent and initiation of study. 
 
Ongoing verbal consent to activity will be addressed daily, when the 
therapist approaches a subject for scheduled therapy. 
 
Consent will be obtained via pre-approved form.  
16.2 Non English-Speaking Participants: Any non-English speaking individual 
who is being treated by a physical therapist and who is undergoing ECMO 
treatment would be eligible for consent. As advised by IRB, a line on the 
consent form indicating who facilitated consent in the case of a non-English 
speaker, has been added.  

PROTOCOL TITLE: The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing Extracorporeal Membrane 
Oxygenation (ECMO) 
VERSION DATE: 11/28/16 
 
Page 9 of 9 
Revised: 1/19/2018 
 
16.3 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): N/A 
16.4 Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: N/A 
16.5 Adults Unable to Consent: N/A 
17.0 Setting 
17.1 Research Sites: Fairview, University of Minnesota Medical Center, East 
Bank Hospital. Treatment and consent will occur in the hospital room of 
each subject. 
18.0 Multi-Site Research:  
N/A 
19.0 Resources Available 
19.1 Resources Available: Resources Available: Feasibility of subjects is 
dependent on the number of individuals undergoing ECMO treatment and 
able to provide consent. This is a pilot study.  
 
Research space and software is available at the University of 
Minnesota, Division of Physical Therapy. Data collection will be 
completed at Fairview, East Bank Hospital. 
 
All research support staff have been trained on the protocol, completed 
regulatory HIPAA and CITI training.  
 

 
1 
 
 
 
Project Proposal: 11/28/16 
 
 
 
 
 
 
 
 
The Impact of Lower Extremity Weight-Bearing Leg Exercise 
During the Pre-Ambulation Phase of Individuals Undergoing 
Extracorporeal Membrane Oxygenation (ECMO) 
 
 
 
 
Principal Investigator: Amanda LaLonde, PT, DPT, University of Minnesota 
Co- Investigator: Eric Andersen, PT, DPT, University of Minnesota Medical 
Center, Fairview 

 
2 
Project Summary 
 
Patients undergoing extracorporeal membrane oxygenation (ECMO) are at high risk 
for deconditioning and functional decline. Current research provides support for 
early mobilization of patients undergoing ECMO, and indicates that activity in this 
population is safe and feasible. The timeframe prior to mobilization depends on a 
number of factors, and can range significantly between different patient groups. One 
such factor is strength.  
 
While active lower extremity exercise is common in the pre-ambulation phase of 
those receiving ECMO, the type of exercise selected varies and little is know about 
the benefit of weight-bearing closed chain exercise during this pre-ambulatory 
period. In order to evaluate this specific form of exercise, we will compare outcomes 
of patients who complete lower extremity exercise without loading to those who 
complete loaded exercises.  
 
All participants in this study will progress through pre-existing Ambulatory ECMO 
Guidelines, established and currently in use at the University of Minnesota Medical 
Center, Fairview. Participants will be randomized into either group A or B. Group A 
will receive specific closed chain lower extremity squat exercises via the MOVEO XP 
Mobile Hi-Lo Platform System. MOVEO is an exercise leg press device. The MOVEO 
exercises will be added during parts C and D of the ECMO Early Mobilization 
Protocol listed below. Group B will progress through the ECMO Early Mobilization 
Protocol without the addition leg exercises on the MOVEO.  
 
Collecting and analyzing data on weight-bearing lower extremity exercise in this 
patient population will allow us to obtain important information on ways to address 
weakness associated with ECMO treatment, particularly in those who are unable to 
engage in bipedal ambulation.  
 
 
 
 
 
MOVEO XP Mobile Hi-Lo  
Platform System 
 
Company Website: 
 
http://www.djoglobal.com/products/cha
ttanooga/moveo-xp 

 
3 
ECMO Early Mobilization Protocol:  
 
1. Readiness for Mobility Assessment and Protocol (Developed by ECMO 
therapy specialists at the University of Minnesota Medical Center) 
a. Passive range of motion (PROM) and monitor for appropriateness of 
entering into the mobility program 
b. Utilization of lift equipment to sit patient at the edge of the bed or into 
chair to promote wakefulness, when on minimal amounts or no 
sedation 
c. Patient demonstrates the ability to follow 3/3 one-step commands 
d. Patient tolerates 5 minutes of lower extremity ergometer, or performs 
ten reps of 3 active ROM of motion exercises involving the lower 
extremities 
e. Sit at bedside unsupported for 5 minutes 
f. Sit<>stand and pre-gait activities (weight shifting, walking in place, 
etc.) directed by therapist 
g. Bedchair transfers (stand-pivot or squat-pivot) 
h. Walking over ground with utilization of the mobility carts  
 
 
 
Subjects 
undergoing 
ECMO
Group A
ECMO 
Mobilization 
Program
+ Leg Press 
Exercise
Group B
ECMO 
Mobilization 
Program Only

 
4 
The primary aim of this study is to assess the functional impact of leg exercise 
during the pre-ambulation phase in patients undergoing ECMO. Outcome measures 
will be categorized as either functional or hospital based. Hospital measures 
include: Hospital days, intensive care unit days, days on ECMO, days on mechanical 
ventilation, length of time from physical therapy evaluation to initial ambulation, 
and discharge disposition. Functional outcome measures include: Leg strength, grip 
strength, 30-second sit to stand test, Functional Status Score for the Intensive Care 
Unit (FSS-ICU), and the Richmond Agitation and Sedation Scale (RASS).  
 
 
Background & Significance 
 
Typical care for persons undergoing ECMO has involved levels of medical sedation 
to the point of unresponsiveness to outside stimuli. Past treatment theories have 
identified numerous contraindications for mobilization (Hodgson et al 2014). 
Recent advances in ECMO cannulation site (veno-venous) now allow these patients 
to safely mobilize. A growing body of evidence has suggested that mobilizing while 
undergoing ECMO is safe, feasible and improves both medical and functional 
outcomes. For example, Abrams et al. (2014) found that physical therapy (PT) may 
increase extracorporeal gas exchange efficiency, and that patients may be earlier 
eligible for extubation as a result of PT. A study by Rehder et al. was suggestive of 
improved post-lung transplant recovery time when patients participated in active 
rehabilitation while on ECMO.  A more recent study in 2016 by Bain et al. concluded 
that subjects who were ambulatory while on ECMO had significant direct medical 
cost reductions including total hospital cost ($60,204), post-transplant ICU cost 
($104,939) and reduction in total cost compared with non-ambulatory ECMO 
subjects ($32,133).  
 
Ambulation, while safe and effective, may not be feasible early on for some critically 
ill patients. In these cases, exercise is often a pre-ambulatory intervention. Selection 
and impact assessment of open versus closed chain exercise has been well 
documented in literature related to recovery after knee injury, but to a lesser degree 
in those who are immobile due to critical illness. Studies have reported knee 
extensor atrophy during bed rest (Bamman 2000) and functional benefit of 
specificity training (Morrissey, et. al 1998), yet little is known about the functional 
effectiveness of loaded closed chain exercises as compared to the open chain 
exercises in the critically ill patient population.  
 
Coupled with known data reflective of muscle changes and strength loss with 
immobility (Puthucherary, et. al 2010), this study aims to broaden the treatment 
repertoire to include lower extremity closed chain muscle training (hip and knee 
extensors) along with determining the safety and feasibility of such an intervention 
for critically ill individuals undergoing ECMO.  
 
 

 
5 
Specific Aims 
 
We are conducting this study to explore the impact of closed-chain leg exercise in 
individuals undergoing ECMO.  
 
Aim 1: To determine if closed-chain leg exercise decreases the time to initial 
ambulation. We hypothesize that adding leg exercise will decrease time to 
ambulation.  
 
Aim 2: To determine the impact of closed chain leg exercise on functional ability. We 
hypothesize that adding leg exercise will improve functional outcomes when added 
to an existing early mobilization program.  
 
Aim 3: To determine the effect of closed chain leg exercise on hospital outcomes. We 
hypothesize that hospital related outcomes will improve when leg exercise is added 
to an existing early mobilization program.  
 
Research Design & Methods 
 
This initial pilot study will be conducted at the University of Minnesota Medical 
Center (UMMC), Fairview, and will involve 10 participants in each of the two groups 
(A and B). To account for attrition, 24 total subjects will be recruited; 12 per group. 
Approximately 3-5 patients are admitted to UMMC each month who are undergoing 
ECMO and could be considered for study inclusion. The study will be conducted with 
a goal endpoint of 1-year. Men and women aged 18-70 years old with refractory 
respiratory failure who are undergoing ECMO will participate over the duration of 
their ECMO treatment and hospitalization.   
 
Recruitment and Consent 
Standard practice includes a physician order for inpatient physical therapy for all 
individuals undergoing ECMO, as well as initial medical sedation. Most of those 
receiving ECMO are at least partially medically sedated at the time of physical 
therapy initiation. Only physical therapists who are specialty-trained ICU therapists 
and who are a part of this project will be working with this group of patients. 
 
Any individual who meets inclusion criteria will be considered for participation, 
pending their ability to follow 3/3 one-step commands, as is outlined in the ECMO 
Mobility Protocol listed previously. Patients will be able to self-consent once 
sedation is reduced. After consent, individuals will be placed into either Group A or 
B and progress through the protocol. Group assignments will be determined based 
on 24 subjects, with the number 24 put into a random letter sequence generator 
prior to subject recruitment.  
 
 
 

 
6 
Inclusion Criteria 
- 
Men and women 18-70 years old with refractory respiratory failure 
undergoing ECMO at the University of Minnesota Medical Center, Fairview.  
- 
Able to follow 3 out of 3 one-step commands via protocol. 
- 
Active Inpatient Physical Therapy Referral.  
- 
ECMO delivery is veno-venous with internal jugular catheter. 
 
Exclusion Criteria 
- 
Femoral catheter of any kind present.  
- 
Veno-arterial ECMO setup. 
- 
Sedation such that self-consent is not attainable.  
- 
Medical instability, as determined by primary critical care physician.  
 
Overview of Protocol for Aims 1-3: 
 Participants in either Group A (closed chain leg exercise group) or B (open chain 
exercise group) will progress through the established ECMO protocol led by their 
physical therapist. Participating therapists have extensive experience in working 
with patients on the Moveo who are in the ICU. Subjects will be assisted in the 
supine position from their bed to the Moveo device via a lateral transfer across a 
slide board to facilitate ease of movement.  
 
Those in Group A will participate in leg exercise on the Moveo during item 4d of the 
ECMO protocol, whereby those in Group B will complete standard exercise as listed 
in item 4d. Group A participants will use the Moveo until subjective report of leg 
fatigue. Participants will self-select the pace of their leg exercise and the primary 
therapist will determine guidelines for percent of body weight lifted in accordance 
with standard practice physical therapy. Subjects will complete 1-4 sets of up to 25 
reps of the squat exercise with 2 minutes of rest between each set. Subjects will 
receive physical therapy 5 days/week regardless of randomization into Group A or 
Group B. 
 
Data Collection for Aims 1-3: Data will be collected on Day 0 (physical therapy 
evaluation day), Day 5, Day 10, Day 15, Day 20, Day 30, Day 45 (if applicable), and 
Day of discharge. Data collected will be categorized as specific to Aim 1 (time from 
initial physical therapy evaluation to initial ambulation), Aim 2 (functional 
outcomes) and Aim 3 (hospital outcomes). Recording of physiological data including 
heart rate (HR), blood pressure (BP), oxygen saturation (O2), and respiratory rate 
(RR) will be completed by trained physical therapists involved in the protocol at the 
onset of, and 1-minute post-conclusion of each therapy session. Therapy sessions 
are to be delivered at a frequency of five sessions per week. 
 
 Functional Outcomes 
o Leg strength as assessed by primary therapist via manual muscle test, 
using the Medical Research Council Sum Score (MRC Score) 
o Grip strength, as assessed by hand dynamometer, completed by 
primary therapist 

 
7 
o 30-second sit to stand, completed by primary therapist 
o Richmond Agitation and Sedation Scale (RASS), as completed in 
medical record by primary nurse 
o Functional Status Score for the Intensive Care Unit (FSS-ICU) 
 
 Hospital Outcomes (data extraction from medical record) 
o Hospital days 
o Intensive care unit days 
o Days on ECMO 
o Days on mechanical ventilation 
o Length of time from physical therapy evaluation to initial ambulation 
o Discharge disposition- assigned a number for statistical analysis 
 Home (1) 
 Home with assistance (2) 
 Home with home therapy (3) 
 Home with outpatient therapy (4) 
 Transitional Care Unit (5) 
 Acute Inpatient Rehabilitation (6) 
 Long-term acute care hospital (7) 
 Long-term care setting (8) 
 Transfer to outside hospital (9) 
 
 Physiological Monitoring: Monitoring physical therapists have extensive 
experience in mobilizing patients in the ICU, including those with arterial 
lines and on ventilation, as is standard practice for ICU therapy.  
o Respiratory rate (RR) via Drager Ventilators 
 Evita Series or Infinity Series 
o Oxygen (SpO2) and heart rate (HR) 
 Spacelabs Ultraview SL2700 (regular monitor) 
 Spacelabs Ultraview SL (portable monitor) 
o Blood Pressure (BP) via manual cuff or arterial line  
 Spacelabs Ultraview SL2700 or SL 
 
Statistical Considerations 
 
Physiological data (HR, BP, O2, RR) will be recorded throughout the study and 
analyzed between Groups A and B. Functional and Hospital outcomes will be 
analyzed to compare group differences at each of the data collection days (0, 5, 10, 
15, 20, 30, 45, day of discharge.   
 
Data will be analyzed at the University of Minnesota using the Statistical Package for 
Social Sciences (SPSS) software program. Test for normality will be completed via a 
paired t-test for parametric data and via Wilcoxon Rank Sum Test for non-
parametric data.  
 

 
8 
Aim 1: Leg exercise on the Moveo will decrease time to initial ambulation.  
 A paired t-test will be used to evaluated time to ambulation in Group A as 
compared to Group B.   
 
Aim 2: Leg exercise on the Moveo will improve functional outcomes. 
 There are 2 primary factors to assess, Group A and B, as well as the impact 
across time. To assess both factors, repeated measures ANOVA will be used.  
 
Aim 3: Leg exercise on the Moveo will improve hospital outcomes.  
 All hospital outcomes, except for discharge disposition, can be assessed 
between Group A and Group B by a paired t-test.  
 Discharge disposition, categorical data, will be analyzed via Chi-Square test. 
 
 
Data and Safety Monitoring Plan 
 
Study personnel who have completed HIPAA, CITI, and other data management 
training through the University of Minnesota Medical Center, Fairview and the 
University of Minnesota will be responsible for the collection, management, and 
analysis of study data.  
 
Participants will be randomized to groups through a randomization service prior to 
study initiation. All participants will be assigned a subject number that will be 
stored on a computer at the University of Minnesota, which is password protected. 
Data collected from participant’s medical records will be managed exclusively by the 
primary therapist and the PI, and stored in a password protected data management 
system through Research Electronic Data Capture (REDCap), available at the 
University of Minnesota. 
 
In accordance with regulations, participant records will be stored for a minimum of 
three years following completion of the study. After the stated timeframe and if data 
is no longer needed, records will be destroyed.  
 
Confidentiality 
 
For the duration of the study and data analysis, precautions will be taken to ensure 
the confidentiality of protected health information (PHI).  Such precautions include: 
the use of password-protected computer for data analysis, PHI storage in the 
REDCap management program, de-identification of forms and use of assigned 
subject number, and data collection completed by the primary investigator.  
 
 
 
 

 
9 
Potential Risks 
 
Lower Extremity Exercise: As with any new exercise program, muscle fatigue or 
mild soreness may occur in the 24-48 hours following exercise. This minor effect 
will not impact mobility or function in any way.  
 
Mobilization Protocol: Subjects participating are undergoing ECMO due to 
respiratory failure and are critically ill. To maximize safety and minimize risks, the 
primary physical therapist will communicate with the medical team daily to ensure 
subjects are appropriate for mobilization and participation in physical therapy. Dr. 
Melissa Brunsvold, Acute Care Surgery physician at the University of Minnesota 
Medical Center, Fairview, is the primary medical contact for these subjects and is 
actively involved in the implementation of the ECMO Mobilization Program. Dr. 
Brunsvold is responsible for removing active physical therapy orders, as is any 
critical care physician, if an individual undergoing ECMO is no longer stable for 
mobilization or exercise. Orders will be verified daily, prior to physical therapy, by 
the primary therapist. 
 
Adverse Event Reporting 
Subjects in this study are patients at the University of Minnesota Medical Center, 
Fairview. As a result, adverse events will be reported not only in the medical record 
of the subject, but also recorded by the investigator.  
 
Any adverse event will be followed and assessed until it has been determined that 
the study treatment or participation is not the cause.  
 
Adverse Events 
 
Adverse events observed or reported will be recorded in the case histories of each 
participant to determine if:  
 
1. The event is directly related to the study and should be classified as a serious 
adverse event (SAE) 
2. A causal relationship exists between the adverse event effect and the 
investigational exercise/mobility program 
 
Any adverse event not determined to quality, as a SAE will be reported to the IRB 
with the continuing review progress report.  
 
Stopping Rules 
 
If a SAE occurs, which is deemed by the overseeing physician, Dr. Brunsvold, to be a 
direct result from the study intervention, the study will be put on hold and reviewed 
by the PI to determine whether or not the study can continue.  
 

 
10
Any deviation from the intended investigational plan to protect the life or well being 
of a participant in an emergency will be reported to the IRB within 5 working days 
after the emergency occurred.  
 
As a part of the consent process, participants will be notified that they can 
withdrawal at any time during the study. Data collected prior to withdrawal of any 
subject may still be used for data analysis. There is no compensation associated with 
this pilot investigation.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
11
References 
 
Abrams D, Javidfar J, Farrand E, Mongero LB, Agerstrand CL, Ryan P, Zemmel D, 
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