Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT03299101
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Actual Duration (Months): 34.3
• Patients Per Site Per Month: 1

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. The investigators 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, home-based prehabilitation intervention aimed at improving surgical outcomes after cardiothoracic surgery 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
Coronary Artery Bypass Graft; Non-cardiac Thoracic Surgery; Frailty	Other: Prehabilitation	N/A

Detailed Description

Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgical techniques have advanced to a level where surgery on very old adults is feasible, if a patient is also frail, the stress of surgery may overwhelm their adaptive capacities, placing them at increased risk of mortality, morbidity, and institutionalization even if surgery is technically successful. Frailty is a clinical syndrome that is commonly characterized by muscle atrophy, diminished strength and speed, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age and worsens disease prognoses by diminishing capacity to tolerate stressors. Thus, while surgery is often indicated for older patients, frail candidates are less likely than robust counterparts to tolerate the procedure and/or recover functional capacity. In fact, recent VA data demonstrate that frailty 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, frailty will increase, making it critically important to identify effective strategies for improving the surgical recovery and outcomes of frail 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 and improving nutrition. Based on this success, there is growing interest in "prehabilitation", which is a similar intervention deployed before surgery. By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of surgery itself and the convalescent period thereafter. Frail patients may benefit disproportionately from prehabilitation because they have diminished capacity to endure the procedure and/or recovery. Preliminary evidence suggests that preoperative exercise interventions improve surgical outcomes. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations, and no prior studies used home-based prehabilitation strategies to safely minimize travel-related barriers to participation.

Objectives: The investigators will examine the feasibility of a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Specific aims are to:

1. Estimate rates of recruitment, retention, and adherence to the intervention; and evaluate participation barriers.

2. Measure changes over time in frailty, physical function, pulmonary function, nutrition, and health-related quality of life at baseline, the day of surgery, and 30 and 90 days after surgery.

3. Explore changes in postoperative mortality, major complications, length of hospital stay, and level of independent living using case-matched historical controls.

Methods: This single-arm pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major cardiothoracic surgery at the VA Pittsburgh Healthcare System. The 4 week long prehabilitation regimen will include: (a) aerobic conditioning, (b) strength and coordination training, (c) respiratory muscle training, and (d) nutritional coaching and supplementation. Pre- and post-prehabilitation assessments will include: (a) frailty; (b) physical function; (c) pulmonary function; (d) nutrition; and (e) health-related quality of life. Postoperative outcomes will include length of stay, mortality and complications. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the 42,000 frail Veterans scheduled for major elective surgery each year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A novel a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Prehabilitation will include: (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.A novel a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Prehabilitation will include: (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Pilot Testing a Home-based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
• Actual Study Start Date: Nov 22, 2017
• Actual Primary Completion Date: Apr 30, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prehabilitation Prospective sample of patients anticipating cardiothoracic surgery.	Other: Prehabilitation; Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.

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. Retention Rate [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.

3. Adherence Rate [Day of surgery]

   Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.

Secondary Outcome Measures

1. Change in Grip Strength Over the Course of Treatment and Recovery. [Baseline, day of surgery, 90 days postoperatively]

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

2. Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP [Baseline, day of surgery, 90 days postoperatively]

   Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).

3. Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP [Baseline, day of surgery, 90 days postoperatively]

   Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).

4. Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP [Baseline, day of surgery, 90 days postoperatively]

   Pulmonary function will be measured in terms of maximum MEP (maximal expiratory pressures)

5. Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP [Baseline, day of surgery, 90 days postoperatively]

   Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).

6. Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP [Baseline, day of surgery, 90 days postoperatively]

   Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).

7. Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP [Baseline, day of surgery, 90 days postoperatively]

   Pulmonary function will be measured in terms of mean sustained MIP (SMIP).

8. Serum Prealbumin Over the Course of Treatment and Recovery [Baseline, day of surgery, 90 days postoperatively]

   Higher levels indicate greater levels of protein. Lower levels indicate the potential of inflammation. normal range is 18-41, Below 18 is lower than normal, above 41 is higher than normal

9. Change in Gait Speed Over the Course of Treatment and Recovery [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

10. Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery [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.

11. Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery [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.

12. Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery [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.

13. Change in 6 Minute Walk Test Over the Course of Treatment and Recovery [Baseline, day of surgery, 90 days postoperatively]

    This standardized approach measures the distance in meters walked during 6 minutes.

14. Change in Health Related Quality of Life Over the Course of Treatment and Recovery [Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively]

    Assessment of Quality of Life (AQoL-6D) survey. Scores range from 0 to 1. The higher the score, the better the quality of life.

Other Outcome Measures

1. Change in Quality of Surgical Care Over the Course of Treatment and Recovery [Day of Surgery and 30-days postoperatively]

   Agency for Healthcare Research and Quality (AHRQ) Surgical Care Survey (SCS) total communication section. Values are scored on a 3 point scale where 1 is good and 3 bad

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Veteran patient scheduled for Coronary artery bypass graft (CABG), valve surgery, or other non-cardiac thoracic surgery;

2. Demonstrate at least mild frailty (e.g., Risk Analysis Index [RAI]>=16).

3. Physician/provider request for patients with RAI<16.

Exclusion Criteria:

• Emergent, urgent, or otherwise time-sensitive surgery that precludes prehabilitation;

• Unstable or recent unstable cardiac syndrome as defined by (a) acute coronary syndrome within 6 weeks; (b) decompensated heart failure; (c) New York Heart Association Class IV Heart Failure; (d) unstable angina; (e) Canadian Cardiovascular Society Class IV symptoms; (f) critical left main coronary disease; (g) clinically significant arrhythmias,

• Severe valvular heart disease: (a) severe aortic or mitral stenosis (aortic or mitral valve area <1.0 cm2 or mean gradient >40 or >10 mm Hg, respectively)

• Dynamic LV (Left Ventricle) outflow obstruction

• Physical, cognitive, social or logistical limitations preventing participation in the prehabilitation regimen, including:

• Patients who require surrogate consent for the planned surgery

• Patients with court orders of incompetence or clinical determinations of incapacity documented in the medical record

• Clinical exam by study physician consistent with incapacity

• Patients who at any time during prehabilitation or longitudinal follow up demonstrate insufficient cognitive capacity to safely and effectively carry out the prescribed activities.

• Unable to speak English.

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

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 - Jul 24, 2020

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT03299101
• Other Study ID Numbers: E2562-P; I21RX002562
• First Posted: Oct 2, 2017
• Last Update Posted: Jan 13, 2021
• Last Verified: Dec 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: Frailty; Prehabilitation; Exercise therapy; Surgery; Nutrition support
• Additional relevant MeSH terms: Frailty

Study Results

Participant Flow

Arm/Group Title	Prehabilitation
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Period Title: Overall Study
STARTED	35
COMPLETED	25
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Prehabilitation
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Overall Participants	33
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	11 33.3%
>=65 years	22 66.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.09 (7.66)
Sex: Female, Male (Count of Participants)
Female	2 6.1%
Male	31 93.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	33 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 6.1%
White	31 93.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	33 100%
Risk Analysis Index (Score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score on a scale]	17.85 (8.92)

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

65 is the number of patients approached.

Arm/Group Title	Prehabilitation
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	65
Count of Participants [Participants]	35 106.1%

2. 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	90 days postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prehabilitation
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	35
Count of Participants [Participants]	25 75.8%

3. Primary Outcome

Title	Adherence Rate
Description	Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.
Time Frame	Day of surgery

Outcome Measure Data

Analysis Population Description

All participants that self-reported their home training and/or showed their exercise or nutrition logs were analyzed.

Arm/Group Title	Prehabilitation
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	27
Home Strength/Aerobic/Transition Training	78.85 (28.96)
Home Breathing Training	86.30 (24.20)
Home Nutrition Log	64.09 (14.10)

4. Secondary Outcome

Title	Change in Grip Strength Over the Course of Treatment and Recovery.
Description	Grip strength will be measured in kilograms of pressure using a Smedley 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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline Grip Strength	31.52 (9.27)
Day of Surgery Grip Strength	32.19 (7.89)
90 Days Post Surgery	31.13 (9.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in grip strength across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.872
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in grip strength between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.423
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.57
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.71
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in grip strength between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.853
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.12
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in grip strength between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.552
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.28
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.16
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

5. Secondary Outcome

Title	Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
Description	Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline Max MIP	71.42 (24.54)
Day of surgery Max MIP	77.96 (24.23)
90 Day Postop Max MIP	79.82 (26.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in max MIP across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.256
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in maximum MIP between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.091
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.69
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.78
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in maximum MIP between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.066
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	6.80
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.69
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in maximum MIP between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.552
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.86
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.13
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

6. Secondary Outcome

Title	Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
Description	Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline Mean MIP	60.69 (23.57)
Day of surgery Mean MIP	69.38 (23.11)
90 Day Postop Mean MIP	71.43 (26.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in mean MIP across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean MIP between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	7.48
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.48
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean MIP between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.18
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.61
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean MIP between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.290
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.31
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.18
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

7. Secondary Outcome

Title	Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
Description	Pulmonary function will be measured in terms of maximum MEP (maximal 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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline Max MEP	108.09 (33.64)
Day of surgery Max MEP	120.81 (30.40)
90 Day Postop Max MEP	123.64 (32.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in maximal inspiratory pressure across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in maximum MEP between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	12.61
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.57
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in maximum MEP between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	12.79
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.25
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in maximum MEP between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.802
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.86
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.42
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

8. Secondary Outcome

Title	Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
Description	Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline Mean MEP	98.48 (32.90)
Day of surgery Mean MEP	111.22 (28.62)
90 Day Postop Mean MEP	112.01 (31.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in Mean MEP across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.010
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean MEP between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	12.37
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.35
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean MEP between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.042
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.95
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.90
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.221
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.77
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.08
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

9. Secondary Outcome

Title	Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
Description	Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline Max SMIP	416.55 (197.85)
Day of surgery Max SMIP	434.48 (192.42)
90 Day Postop Max SMIP	466.77 (197.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in max SMIP across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.814
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in maximum SMIP between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.734
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	10.50
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 30.91
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in maximum SMIP between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.341
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	21.07
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 22.12
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in maximum SMIP between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.448
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	28.55
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 37.61
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

10. Secondary Outcome

Title	Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
Description	Pulmonary function will be measured in terms of mean sustained MIP (SMIP).
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline Mean SMIP	364.36 (171.33)
Day of surgery Mean SMIP	393.86 (185.85)
90 Day Postop Mean SMIP	435.94 (202.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in mean SMIP across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.419
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean SMIP between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.439
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	20.91
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 27.03
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean SMIP between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.069
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	47.67
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 26.19
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean SMIP between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.328
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	37.11
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 37.96
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

11. Secondary Outcome

Title	Serum Prealbumin Over the Course of Treatment and Recovery
Description	Higher levels indicate greater levels of protein. Lower levels indicate the potential of inflammation. normal range is 18-41, Below 18 is lower than normal, above 41 is higher than normal
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	23
Baseline Serum Prealbumin	26.27 (5.57)
Day of surgery Serum Prealbumin	26.50 (4.52)
90 Day Postop Serum Prealbumin	25.13 (6.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in serum prealbumin across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.196
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in serum prealbumin between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.562
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in serum prealbumin between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.087
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.42
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in serum prealbumin between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.226
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.28
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

12. Secondary Outcome

Title	Change in Gait Speed Over the Course of Treatment and Recovery
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline Gait Speed	1.16 (0.32)
Day of surgery Gait Speed	1.33 (0.28)
90 Day Postop Gait Speed	1.36 (0.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in gait speed across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in gait speed between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.04
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in gait speed between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.16
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.05
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in gait speed between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.874
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.05
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

13. Secondary Outcome

Title	Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline SPPB	10.44 (1.74)
Day of surgery SPPB	10.83 (1.17)
90 Day Postop SPPB	10.64 (1.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in SPPB across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.854
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in SPPB between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.298
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.32
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in SPPB between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.684
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.13
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.31
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in SPPB between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.485
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

14. Secondary Outcome

Title	Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	33
Baseline RAI	17.85 (8.92)
Day of surgery RAI	20.40 (8.69)
90 Day Postop RAI	23.30 (9.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in RAI across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.067
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in RAI between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.089
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.07
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.22
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in RAI between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.37
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.60
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in RAI between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.221
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.98
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.62
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

15. Secondary Outcome

Title	Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	26
Baseline SGA	6.04 (0.60)
Day of Surgery SGA	6.00 (0.33)
90 Day Postop SGA	5.95 (0.59)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in SGA across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.860
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in SGA between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.410
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.12
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in SGA between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.622
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in SGA between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.757
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

16. Secondary Outcome

Title	Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
Description	This standardized approach measures the distance in meters walked during 6 minutes.
Time Frame	Baseline, day of surgery, 90 days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the six minute walk test were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	32
Baseline 6 Minute Walk Distance	366.49 (108.68)
Day of Surgery 6 Minute Walk Distance	400.33 (101.07)
90 Day Postop 6 Minute Walk Distance	386.96 (94.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change in 6 Minute Walk Test across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.362
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.203
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	25.52
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 20.06
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.357
	Comments	The null hypothesis was rejected a priori if p<0.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	12.70
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 13.77
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in 6 Minute Walk Test between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.163
	Comments	The null hypothesis was rejected a priori if p<0.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	21.48
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 15.40
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

17. Secondary Outcome

Title	Change in Health Related Quality of Life Over the Course of Treatment and Recovery
Description	Assessment of Quality of Life (AQoL-6D) survey. Scores range from 0 to 1. The higher the score, the better the quality of life.
Time Frame	Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed all of the AQoL6D assessment were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	25
Baseline AQoL6D Utility Score	0.72 (0.16)
Day of surgery AQoL6D Utility Score	0.75 (0.13)
90 Day Postop AQoL6D Utility Score	0.77 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change across all 4 time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.068
	Comments
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change between baseline and day of surgery.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.043
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.02
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change between baseline and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.092
	Comments	The null hypothesis was rejected a priori if p<.05.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.02
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.292
	Comments
	Method	Mixed Models Analysis
	Comments	The null hypothesis was rejected a priori if p<.05.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.02
	Estimation Comments	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.

18. Other Pre-specified Outcome

Title	Change in Quality of Surgical Care Over the Course of Treatment and Recovery
Description	Agency for Healthcare Research and Quality (AHRQ) Surgical Care Survey (SCS) total communication section. Values are scored on a 3 point scale where 1 is good and 3 bad
Time Frame	Day of Surgery and 30-days postoperatively

Outcome Measure Data

Analysis Population Description

All participants that completed the every question of the AHRQ SCS total communication section assessment were analyzed at each completed timepoint.

Arm/Group Title	Prehabilitation
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
Measure Participants	25
Day of surgery Total Communication	1.08 (0.16)
30 Day Postop Total Communication	1.13 (0.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prehabilitation
	Comments	Linear mixed models estimated overall, within-person change across both time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.625
	Comments
	Method	Mixed Models Analysis
	Comments

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
Arm/Group Description	Prospective sample of patients anticipating cardiothoracic surgery. Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
All Cause Mortality
	Prehabilitation
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Serious Adverse Events
	Prehabilitation
	Affected / at Risk (%)	# Events
Total	7/35 (20%)
Blood and lymphatic system disorders
Orthostatic Hypotension	1/35 (2.9%)	1
General disorders
Unrelated inpatient hospitalization	1/35 (2.9%)	2
Detox	1/35 (2.9%)	1
Injury, poisoning and procedural complications
Post-operative pain unrealted inpatient hospitalization	1/35 (2.9%)	1
Respiratory, thoracic and mediastinal disorders
Unrelated inpatient hospitalization	1/35 (2.9%)	2
Surgical and medical procedures
Second unexpect surgery	1/35 (2.9%)	1
Vascular disorders
Suspected ischemic stroke	1/35 (2.9%)	1
Other (Not Including Serious) Adverse Events
	Prehabilitation
	Affected / at Risk (%)	# Events
Total	0/35 (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.