Piloting Prehabilitation Before Abdominal Surgery

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03040336
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.8
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients. Prior research shows that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. We believe that similar improvements may be obtained by using similar interventions before surgery to "prehabilitate" patients' capacity to tolerate the stress of surgery. The proposed research will examine the feasibility of a new, prehabilitation intervention aimed at improving postoperative surgical outcomes through preoperative exercise training and nutritional supplementation. Findings from the study will inform the design of a larger randomized controlled trial of the prehabilitation intervention. If proven effective, prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery each year.

Condition or Disease	Intervention/Treatment	Phase
Frailty	Behavioral: Prehabilitation	N/A

Detailed Description

Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgeons operate safely on even the oldest old, if the elder is also frail, the stress of surgery can result in significant mortality, morbidity, and institutionalization. Frailty is a clinical syndrome marked by muscle atrophy, diminished strength, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age, and is a more powerful predictor of increased perioperative mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US populations grow older and more frail, it is critically important to identify effective strategies for improving the surgical outcomes of these patients.

"Prehabilitation" has the potential to improve surgical outcomes among the frail. Prior research demonstrates that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength, improving nutrition, and optimizing home supports. Based on this success, there is growing interest in deploying similar interventions before surgery in what some call "prehabilitation." By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of both surgery and recovery. Frail patients will likely benefit disproportionately from prehabilitation because they have the most diminished capacity to adapt to the stress of surgery. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations.

Objectives: We will examine the feasibility of a novel, multifaceted pre-habilitation intervention aimed at improving postoperative outcomes for frail Veterans undergoing major abdominal surgery. Specific aims are to:

1. Estimate rates of recruitment, randomization, retention, and compliance with the prehabilitation intervention;

2. Measure (a) physical performance, (b) pulmonary function, and (c) nutrition at baseline and 2-week intervals to estimate changes over time and explore the optimal duration of prehabilitation (2 vs. 4 vs. 6 weeks); and

3. Estimate overall and treatment-specific summary statistics for postoperative outcomes in terms of 30- and 90-day (a) mortality, (b) major complications, (c) length of hospital stay, (d) health-related quality of life, (e) quality of surgical care, and (f) change in level of independent living.

Methods: This randomized pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major abdominal surgery on the general or urological surgery services at the VA Pittsburgh Healthcare System. We will randomize participants 1:1 to receive either: (1) standard preoperative optimization by the Interdisciplinary Medical Preoperative Assessment Consultation & Treatment Clinic (IMPACT), or (2) prehabilitation + standard IMPACT optimization. The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation. Assessments will include standard postoperative outcomes as well as the Short Physical Performance Battery to measure physical performance, Maximal Inspiratory Pressure to measure pulmonary function, and both prealbumin and the 7-point Subjective Global Assessment to measure nutrition. Outcomes will be assessed 30 or 90 days after surgery. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform the development of a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the as many as 42,000 frail Veterans scheduled for major elective surgery each year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Pilot Testing Prehabilitation Services Aimed at Improving Outcomes of Frail Veterans Following Major Abdominal Surgery
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Dec 28, 2018
• Actual Study Completion Date: Dec 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prehabilitation Standard of care + Prehabilitation	Behavioral: Prehabilitation; The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
No Intervention: Standard of Care Standard of Care

Outcome Measures

Primary Outcome Measures

1. Recruitment Rate [Baseline]

   Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.

2. Randomization Rate [Baseline]

   Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions

3. Retention Rate [Baseline to 90 days postoperatively]

   Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.

4. Compliance Rate [Baseline to Day of Surgery]

   Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions.

Secondary Outcome Measures

1. Grip Strength [Baseline, day of surgery, 90 days postoperatively]

   Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer

2. Pulmonary Function [Baseline, day of surgery, 90 days postoperatively]

   Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.

3. Serum Prealbumin [Baseline, day of surgery, 90 days postoperatively]

   Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.

4. Gait Speed [Baseline, day of surgery, 90 days postoperatively]

   Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters.

5. Short Physical Performance Battery (SPPB) [Baseline, day of surgery, 90 days postoperatively]

   This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.

6. Risk Analysis Index of Frailty (RAI)_questionnaire [Baseline, day of surgery, 90 days postoperatively]

   This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.

7. 7-point Subjective Global Assessment of Nutrition_questionnaire [Baseline, day of surgery, 90 days postoperatively]

   This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.

Other Outcome Measures

1. Postoperative Mortality [30 and 90 days postoperatively]

   Postoperative mortality

2. Health Related Quality of Life [Baseline, day of surgery, 90-days postoperatively]

   Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.

3. Quality of Surgical Care [Day of Surgery and 30-days postoperatively]

   AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Frail as defined by an Risk Analysis Index (RAI) score >=16

• Scheduled for Major Abdominal Surgery as defined by a procedure that plans to violate the peritoneum or retroperitoneum (excluding inguinal hernias)

Exclusion Criteria:

• Unable to participate in planned Prehabilitation regimen

• Surgery is cancelled by IMPACT clinic or surgeon due to unacceptable risk

• Left ventricular ejection fractions <35%

• Severe valvular heart disease

• Significant arrhythmia

• Cognitive impairments that necessitate surrogate informed consent for the planned surgery

• Unable to speak English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Daniel E. Hall, MD MDiv MHSc, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 3, 2019

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03040336
• Other Study ID Numbers: PPO 16-335; HX-002345
• First Posted: Feb 2, 2017
• Last Update Posted: Mar 10, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: surgery; prehabilitation; exercise therapy; nutrition support
• Additional relevant MeSH terms: Frailty

Study Results

Participant Flow

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Period Title: Overall Study
STARTED	10	7
COMPLETED	7	4
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Prehabilitation	Standard of Care	Total
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care	Total of all reporting groups
Overall Participants	10	7	17
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 10%	1 14.3%	2 11.8%
>=65 years	9 90%	6 85.7%	15 88.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.22 (7.48)	71.71 (11.08)	73.69 (7.86)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	10 100%	7 100%	17 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	10 100%	7 100%	17 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 20%	2 28.6%	4 23.5%
White	8 80%	5 71.4%	13 76.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	10 100%	7 100%	17 100%

Outcome Measures

1. Primary Outcome

Title	Recruitment Rate
Description	Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

54 is the number of patients approached. Only 17 were consented and overall analyzed.

Arm/Group Title	Approached
Arm/Group Description	Patients approached to participate.
Measure Participants	54
Count of Participants [Participants]	17 170%

2. Primary Outcome

Title	Randomization Rate
Description	Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

17 participants were overall analyzed. 10 were randomized to prehab, 7 were randomized to standard of care.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	17	17
Count of Participants [Participants]	10 100%	7 100%

3. Primary Outcome

Title	Retention Rate
Description	Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.
Time Frame	Baseline to 90 days postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	10	7
Count of Participants [Participants]	7 70%	4 57.1%

4. Primary Outcome

Title	Compliance Rate
Description	Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions.
Time Frame	Baseline to Day of Surgery

Outcome Measure Data

Analysis Population Description

The compliance rate is only calculated for the prehabilitation arm.

Arm/Group Title	Prehabilitation
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
Measure Participants	10
Home exercise log	56 (42.74)
Nutrition log	10 (31.62)
On site exercise sessions	93.6 (7.60)

5. Secondary Outcome

Title	Grip Strength
Description	Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer
Time Frame	Baseline, day of surgery, 90 days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the hand grip assessment were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	10	7
Baseline	26.38 (4.99)	27.75 (11.19)
Day of Surgery	29.00 (5.38)	32.00 (13.88)
90 days	23.75 (4.23)	33.63 (11.28)

6. Secondary Outcome

Title	Pulmonary Function
Description	Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.
Time Frame	Baseline, day of surgery, 90 days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	10	7
Baseline Max MIP	66.00 (27.20)	79.33 (30.81)
Day of Surgery Max MIP	70.11 (29.75)	90.00 (19.97)
90 Day Max MIP	63.17 (32.00)	100.00 (11.53)
Baseline Max MEP	90.60 (34.97)	114.67 (41.56)
Day of Surgery Max MEP	108.67 (35.22)	112.33 (35.64)
90 Day Max MEP	97.67 (30.50)	102.75 (19.48)

7. Secondary Outcome

Title	Serum Prealbumin
Description	Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.
Time Frame	Baseline, day of surgery, 90 days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the blood draw were analyzed at each completed timepoint. Additionally, there was an error in the lab when processing the blood samples, this caused many samples to be evaluated incorrectly. Only correctly analyzed labs were included in this analysis.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	9	4
Baseline Prealbumin	26.5 (4.93)	29 (2.83)
Day of Surgery Prealbumin	22.5 (6.36)	25.5 (2.12)
90 Day Prealbumin	23.6 (8.44)	22 (0)

8. Secondary Outcome

Title	Gait Speed
Description	Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters.
Time Frame	Baseline, day of surgery, 90 days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the gait speed assessment were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	10	7
Baseline Gait Speed	0.98 (0.30)	1.54 (0.55)
Day of Surgery Gait Speed	1.00 (0.17)	1.07 (0.15)
90 Day Gait Speed	1.07 (0.40)	1.21 (0.20)

9. Secondary Outcome

Title	Short Physical Performance Battery (SPPB)
Description	This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.
Time Frame	Baseline, day of surgery, 90 days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the SPPB assessments were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	10	7
Baseline SPPB	9.13 (2.30)	10.6 (1.52)
Day of Surgery SPPB	10.56 (0.88)	11 (0)
90 Day SPPB	9.8 (1.79)	10.75 (0.96)

10. Secondary Outcome

Title	Risk Analysis Index of Frailty (RAI)_questionnaire
Description	This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.
Time Frame	Baseline, day of surgery, 90 days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the RAI assessment were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	10	7
Baseline RAI	31.57 (11.86)	24.75 (0.50)
Day of Surgery RAI	27.86 (12.79)	29.00 (5.66)
90 Day RAI	29.00 (10.39)	26.67 (2.89)

11. Secondary Outcome

Title	7-point Subjective Global Assessment of Nutrition_questionnaire
Description	This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.
Time Frame	Baseline, day of surgery, 90 days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the Subjective Global Assessment were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	10	7
Baseline Subjective Global Assessment	5.43 (0.79)	6.4 (0.55)
Day of Surgery Subjective Global Assessment	5.14 (1.07)	6.00 (0)
90 Day Subjective Global Assessment	5.14 (1.07)	6.33 (0.58)

12. Other Pre-specified Outcome

Title	Postoperative Mortality
Description	Postoperative mortality
Time Frame	30 and 90 days postoperatively

Outcome Measure Data

Analysis Population Description

The mortality questionnaire was completed for all participants still enrolled in the study at the indicated time point.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	9	4
30-days mortality	0 0%	0 0%
90-days mortality	1 10%	0 0%

13. Other Pre-specified Outcome

Title	Health Related Quality of Life
Description	Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.
Time Frame	Baseline, day of surgery, 90-days postoperatively

Outcome Measure Data

Analysis Population Description

Not all participants were analyzed, because this measure requires participants to complete the questionnaire and not all participants did.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	7	3
Baseline	0.72 (0.09)	0.67 (0.05)
Day of Surgery	0.68 (0.08)	0.77 (0.01)
90-days postoperative	0.75 (0.09)	0.80 (0.07)

14. Other Pre-specified Outcome

Title	Quality of Surgical Care
Description	AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.
Time Frame	Day of Surgery and 30-days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the assessment were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation	Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.	Patient received the standard hospital care
Measure Participants	9	5
Day of Surgery Total Communication	1.33 (0.37)	1.13 (0.18)
30-days Total Communication	1.25 (0.29)	1.19 (0.24)

Adverse Events

Time Frame	Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
Arm/Group Title	Prehabilitation		Standard of Care
Arm/Group Description	Standard of care + Prehabilitation Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.		Patient received the standard hospital care
All Cause Mortality
	Prehabilitation		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		0/7 (0%)
Serious Adverse Events
	Prehabilitation		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/10 (30%)		2/7 (28.6%)
Injury, poisoning and procedural complications
Unexpected and unrelated hospitalization	3/10 (30%)	6	2/7 (28.6%)	2
Respiratory, thoracic and mediastinal disorders
Unexpected and unrelated death	1/10 (10%)	1	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	Prehabilitation		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.