Pilot Testing a Home-Based Rehabilitation Intervention De... | NCT03299101

ID	Type	Description	Link
I21RX002562	U.S. NIH Grant/Contract		View source

Pilot Testing a Home-Based Rehabilitation Intervention De... | NCT03299101 | Trialant

Description Module

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:

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

Arms/Interventions Module

Label	Type	Description	Intervention Names
Prehabilitation	Experimental	Prospective sample of patients anticipating cardiothoracic surgery.	Other: Prehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prehabilitation	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recruitment Rate	Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.	Baseline
Retention Rate	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.	90 days postoperatively
Adherence Rate	Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.	Day of surgery

Secondary Outcomes

Measure	Description	Time Frame
Change in Grip Strength Over the Course of Treatment and Recovery.	Grip strength will be measured in kilograms of pressure using a Smedley grip dynamometer	Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP

Other Outcomes

Measure	Description	Time Frame
Change in Quality of Surgical Care Over the Course of Treatment and Recovery	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	Day of Surgery and 30-days postoperatively

Contacts/Locations Module

Name	Affiliation	Role
Daniel E. Hall, MD MDiv MHSc	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA		Pittsburgh	Pennsylvania	15240	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Prehabilitation	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 24, 2020

Arm/Group Information

ID	Title	Description
BG000	Prehabilitation	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.

Units	Counts
Participants	BG00033

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG00011
>=65 years	BG000

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00066.09± 7.66

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002
Male	BG00031

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000
Not Hispanic or Latino	BG00033

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00033

Risk Analysis Index

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.

Mean

Standard Deviation

Score on a scale

Title

Denominators

Categories

Title	Measurements
	BG00017.85± 8.92

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Recruitment Rate

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

65 is the number of patients approached.

Posted

Count of Participants

Participants

Baseline

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG00065

Title

Denominators

Categories

Title	Measurements
	OG00035

Primary

Retention Rate

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.

Posted

Count of Participants

Participants

90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Primary

Adherence Rate

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

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

Posted

Mean

Standard Deviation

percentage of activities completed

Day of surgery

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in Grip Strength Over the Course of Treatment and Recovery.

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

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

Posted

Mean

Standard Deviation

kgf/cm2

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP

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

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

Posted

Mean

Standard Deviation

cm of H2O

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP

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

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

Posted

Mean

Standard Deviation

cm of H2O

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP

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

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

Posted

Mean

Standard Deviation

cm of H2O

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP

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

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

Posted

Mean

Standard Deviation

cm of H2O

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP

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

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

Posted

Mean

Standard Deviation

cm of H2O

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP

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

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

Posted

Mean

Standard Deviation

cm of H2O

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Serum Prealbumin Over the Course of Treatment and Recovery

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

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.

Posted

Mean

Standard Deviation

mg/dL

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in Gait Speed Over the Course of Treatment and Recovery

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

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

Posted

Mean

Standard Deviation

m/s

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

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

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

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

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

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

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in 6 Minute Walk Test Over the Course of Treatment and Recovery

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

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

Posted

Mean

Standard Deviation

meters

Baseline, day of surgery, 90 days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Secondary

Change in Health Related Quality of Life Over the Course of Treatment and Recovery

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

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Other Pre-specified

Change in Quality of Surgical Care Over the Course of Treatment and Recovery

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

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

Posted

Mean

Standard Deviation

score on a scale

Day of Surgery and 30-days postoperatively

ID	Title	Description
OG000	Prehabilitation	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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Prehabilitation	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.	0	35	7	35	0	35

Serious Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Orthostatic Hypotension	Blood and lymphatic system disorders	Non-systematic Assessment	Patient described slight chest discomfort and tingling to staff, staff noticed that patient was disoriented.	EG0001 events1 affected35 at risk
Suspected ischemic stroke	Vascular disorders	Non-systematic Assessment		EG0001 events1 affected35 at risk
Unrelated inpatient hospitalization	General disorders	Non-systematic Assessment	Chest pain, shortness of breath, shaking chills after surgery	EG0002 events1 affected35 at risk
Detox	General disorders	Non-systematic Assessment	Inpatient prior to surgery for detox.	EG0001 events1 affected35 at risk
Unrelated inpatient hospitalization	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	Hospitalization for shortness of breath	EG0002 events1 affected35 at risk
Post-operative pain unrealted inpatient hospitalization	Injury, poisoning and procedural complications	Non-systematic Assessment		EG0001 events1 affected35 at risk
Second unexpect surgery	Surgical and medical procedures	Non-systematic Assessment	Patient needed a second, unexpected surgery. Unrelated to this protocol.	EG0001 events1 affected35 at risk

Ancestor Terms

ID	Term
D019990	Perioperative Care
D005791	Patient Care
D013812	Therapeutics
D013514	Surgical Procedures, Operative
D015444	Exercise
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Title

Denominators

Categories

Home Strength/Aerobic/Transition Training

- ParticipantsOG00026

Title	Measurements
	OG00078.85± 28.96

Home Breathing Training

- ParticipantsOG00027

Title	Measurements
	OG00086.30± 24.20

Home Nutrition Log

- ParticipantsOG00022

Title	Measurements
	OG00064.09± 14.10

Title

Denominators

Categories

Baseline Grip Strength

- ParticipantsOG00033

Title	Measurements
	OG00031.52± 9.27

Day of Surgery Grip Strength

- ParticipantsOG00025

Title	Measurements
	OG00032.19± 7.89

90 Days Post Surgery

- ParticipantsOG00022

Title	Measurements
	OG00031.13± 9.99

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in grip strength across all 4 time points.	Mixed Models Analysis	0.872								Superiority
OG000	Linear mixed models estimated within-person change in grip strength between baseline and day of surgery.	Mixed Models Analysis	0.423	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	0.57	Standard Error of the Mean	0.71	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in grip strength between baseline and 90 days postop.	Mixed Models Analysis	0.853	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-0.39	Standard Error of the Mean	2.12	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in grip strength between day of surgery and 90 days postop.	Mixed Models Analysis	0.552	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-1.28	Standard Error of the Mean	2.16	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline Max MIP

- ParticipantsOG00033

Title	Measurements
	OG00071.42± 24.54

Day of surgery Max MIP

- ParticipantsOG00026

Title	Measurements
	OG00077.96± 24.23

90 Day Postop Max MIP

- ParticipantsOG00022

Title	Measurements
	OG00079.82± 26.86

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in max MIP across all 4 time points.	Mixed Models Analysis	0.256	The null hypothesis was rejected a priori if p<.05.							Superiority
OG000	Linear mixed models estimated within-person change in maximum MIP between baseline and day of surgery.	Mixed Models Analysis	0.091	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	4.69	Standard Error of the Mean	2.78	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in maximum MIP between baseline and 90 days postop.	Mixed Models Analysis	0.066	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	6.80	Standard Error of the Mean	3.69	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in maximum MIP between day of surgery and 90 days postop.	Mixed Models Analysis	0.552	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	1.86	Standard Error of the Mean	3.13	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline Mean MIP

- ParticipantsOG00033

Title	Measurements
	OG00060.69± 23.57

Day of surgery Mean MIP

- ParticipantsOG00026

Title	Measurements
	OG00069.38± 23.11

90 Day Postop Mean MIP

- ParticipantsOG00022

Title	Measurements
	OG00071.43± 26.10

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in mean MIP across all 4 time points.	Mixed Models Analysis	0.003	The null hypothesis was rejected a priori if p<.05.							Superiority
OG000	Linear mixed models estimated within-person change in mean MIP between baseline and day of surgery.	Mixed Models Analysis	0.003	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	7.48	Standard Error of the Mean	2.48	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in mean MIP between baseline and 90 days postop.	Mixed Models Analysis	0.005	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	10.18	Standard Error of the Mean	3.61	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in mean MIP between day of surgery and 90 days postop.	Mixed Models Analysis	0.290	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	2.31	Standard Error of the Mean	2.18	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline Max MEP

- ParticipantsOG00033

Title	Measurements
	OG000108.09± 33.64

Day of surgery Max MEP

- ParticipantsOG00026

Title	Measurements
	OG000120.81± 30.40

90 Day Postop Max MEP

- ParticipantsOG00022

Title	Measurements
	OG000123.64± 32.64

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in maximal inspiratory pressure across all 4 time points.	Mixed Models Analysis	0.009	The null hypothesis was rejected a priori if p<.05.							Superiority
OG000	Linear mixed models estimated within-person change in maximum MEP between baseline and day of surgery.	Mixed Models Analysis	0.006	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	12.61	Standard Error of the Mean	4.57	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in maximum MEP between baseline and 90 days postop.	Mixed Models Analysis	0.015	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	12.79	Standard Error of the Mean	5.25	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in maximum MEP between day of surgery and 90 days postop.	Mixed Models Analysis	0.802	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-0.86	Standard Error of the Mean	3.42	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline Mean MEP

- ParticipantsOG00033

Title	Measurements
	OG00098.48± 32.90

Day of surgery Mean MEP

- ParticipantsOG00026

Title	Measurements
	OG000111.22± 28.62

90 Day Postop Mean MEP

- ParticipantsOG00022

Title	Measurements
	OG000112.01± 31.72

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in Mean MEP across all 4 time points.	Mixed Models Analysis	0.010	The null hypothesis was rejected a priori if p<.05.							Superiority
OG000	Linear mixed models estimated within-person change in mean MEP between baseline and day of surgery.	Mixed Models Analysis	0.004	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	12.37	Standard Error of the Mean	4.35	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in mean MEP between baseline and 90 days postop.	Mixed Models Analysis	0.042	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	9.95	Standard Error of the Mean	4.90	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.	Mixed Models Analysis	0.221	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-3.77	Standard Error of the Mean	3.08	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline Max SMIP

- ParticipantsOG00033

Title	Measurements
	OG000416.55± 197.85

Day of surgery Max SMIP

- ParticipantsOG00025

Title	Measurements
	OG000434.48± 192.42

90 Day Postop Max SMIP

- ParticipantsOG00022

Title	Measurements
	OG000466.77± 197.27

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in max SMIP across all 4 time points.	Mixed Models Analysis	0.814								Superiority
OG000	Linear mixed models estimated within-person change in maximum SMIP between baseline and day of surgery.	Mixed Models Analysis	0.734	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	10.50	Standard Error of the Mean	30.91	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in maximum SMIP between baseline and 90 days postop.	Mixed Models Analysis	0.341	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	21.07	Standard Error of the Mean	22.12	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in maximum SMIP between day of surgery and 90 days postop.	Mixed Models Analysis	0.448	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	28.55	Standard Error of the Mean	37.61	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline Mean SMIP

- ParticipantsOG00033

Title	Measurements
	OG000364.36± 171.33

Day of surgery Mean SMIP

- ParticipantsOG00025

Title	Measurements
	OG000393.86± 185.85

90 Day Postop Mean SMIP

- ParticipantsOG00022

Title	Measurements
	OG000435.94± 202.14

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in mean SMIP across all 4 time points.	Mixed Models Analysis	0.419								Superiority
OG000	Linear mixed models estimated within-person change in mean SMIP between baseline and day of surgery.	Mixed Models Analysis	0.439	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	20.91	Standard Error of the Mean	27.03	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in mean SMIP between baseline and 90 days postop.	Mixed Models Analysis	0.069	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	47.67	Standard Error of the Mean	26.19	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in mean SMIP between day of surgery and 90 days postop.	Mixed Models Analysis	0.328	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	37.11	Standard Error of the Mean	37.96	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline Serum Prealbumin

- ParticipantsOG00023

Title	Measurements
	OG00026.27± 5.57

Day of surgery Serum Prealbumin

- ParticipantsOG00018

Title	Measurements
	OG00026.50± 4.52

90 Day Postop Serum Prealbumin

- ParticipantsOG00015

Title	Measurements
	OG00025.13± 6.48

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in serum prealbumin across all 4 time points.	Mixed Models Analysis	0.196								Superiority
OG000	Linear mixed models estimated within-person change in serum prealbumin between baseline and day of surgery.	Mixed Models Analysis	0.562	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-0.11	Standard Error of the Mean	0.19	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in serum prealbumin between baseline and 90 days postop.	Mixed Models Analysis	0.087	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-0.42	Standard Error of the Mean	0.25	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in serum prealbumin between day of surgery and 90 days postop.	Mixed Models Analysis	0.226	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-0.28	Standard Error of the Mean	0.23	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline Gait Speed

- ParticipantsOG00033

Title	Measurements
	OG0001.16± 0.32

Day of surgery Gait Speed

- ParticipantsOG00024

Title	Measurements
	OG0001.33± 0.28

90 Day Postop Gait Speed

- ParticipantsOG00022

Title	Measurements
	OG0001.36± 0.37

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in gait speed across all 4 time points.	Mixed Models Analysis	0.001								Superiority
OG000	Linear mixed models estimated within-person change in gait speed between baseline and day of surgery.	Mixed Models Analysis	0.001	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	0.12	Standard Error of the Mean	0.04	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in gait speed between baseline and 90 days postop.	Mixed Models Analysis	0.001	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	0.16	Standard Error of the Mean	0.05	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests	Superiority
OG000	Linear mixed models estimated within-person change in gait speed between day of surgery and 90 days postop.	Mixed Models Analysis	0.874	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	0.01	Standard Error of the Mean	0.05	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline SPPB

- ParticipantsOG00032

Title	Measurements
	OG00010.44± 1.74

Day of surgery SPPB

- ParticipantsOG00024

Title	Measurements
	OG00010.83± 1.17

90 Day Postop SPPB

- ParticipantsOG00022

Title	Measurements
	OG00010.64± 1.94

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in SPPB across all 4 time points.	Mixed Models Analysis	0.854								Superiority
OG000	Linear mixed models estimated within-person change in SPPB between baseline and day of surgery.	Mixed Models Analysis	0.298	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	0.33	Standard Error of the Mean	0.32	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in SPPB between baseline and 90 days postop.	Mixed Models Analysis	0.684	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	0.13	Standard Error of the Mean	0.31	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in SPPB between day of surgery and 90 days postop.	Mixed Models Analysis	0.485	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-0.23	Standard Error of the Mean	0.33	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline RAI

- ParticipantsOG00033

Title	Measurements
	OG00017.85± 8.92

Day of surgery RAI

- ParticipantsOG00025

Title	Measurements
	OG00020.40± 8.69

90 Day Postop RAI

- ParticipantsOG00023

Title	Measurements
	OG00023.30± 9.16

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in RAI across all 4 time points.	Mixed Models Analysis	0.067								Superiority
OG000	Linear mixed models estimated within-person change in RAI between baseline and day of surgery.	Mixed Models Analysis	0.089	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	2.07	Standard Error of the Mean	1.22	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in RAI between baseline and 90 days postop.	Mixed Models Analysis	0.006	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	4.37	Standard Error of the Mean	1.60	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in RAI between day of surgery and 90 days postop.	Mixed Models Analysis	0.221	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	1.98	Standard Error of the Mean	1.62	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline SGA

- ParticipantsOG00026

Title	Measurements
	OG0006.04± 0.60

Day of Surgery SGA

- ParticipantsOG00019

Title	Measurements
	OG0006.00± 0.33

90 Day Postop SGA

- ParticipantsOG00021

Title	Measurements
	OG0005.95± 0.59

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in SGA across all 4 time points.	Mixed Models Analysis	0.860								Superiority
OG000	Linear mixed models estimated within-person change in SGA between baseline and day of surgery.	Mixed Models Analysis	0.410	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-0.10	Standard Error of the Mean	0.12	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in SGA between baseline and 90 days postop.	Mixed Models Analysis	0.622	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-0.09	Standard Error of the Mean	0.17	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in SGA between day of surgery and 90 days postop.	Mixed Models Analysis	0.757	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	-0.05	Standard Error of the Mean	0.15	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline 6 Minute Walk Distance

- ParticipantsOG00032

Title	Measurements
	OG000366.49± 108.68

Day of Surgery 6 Minute Walk Distance

- ParticipantsOG00022

Title	Measurements
	OG000400.33± 101.07

90 Day Postop 6 Minute Walk Distance

- ParticipantsOG00022

Title	Measurements
	OG000386.96± 94.70

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change in 6 Minute Walk Test across all 4 time points.	Mixed Models Analysis	0.362								Superiority
OG000	Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and day of surgery.	Mixed Models Analysis	.203	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	25.52	Standard Error of the Mean	20.06	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and 90 days postop.	Mixed Models Analysis	0.357	The null hypothesis was rejected a priori if p<0.05.	Mean Difference (Net)	12.70	Standard Error of the Mean	13.77	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in 6 Minute Walk Test between day of surgery and 90 days postop.	Mixed Models Analysis	0.163	The null hypothesis was rejected a priori if p<0.05.	Mean Difference (Net)	21.48	Standard Error of the Mean	15.40	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Title

Denominators

Categories

Baseline AQoL6D Utility Score

- ParticipantsOG00025

Title	Measurements
	OG0000.72± 0.16

Day of surgery AQoL6D Utility Score

- ParticipantsOG00022

Title	Measurements
	OG0000.75± 0.13

90 Day Postop AQoL6D Utility Score

- ParticipantsOG00021

Title	Measurements
	OG0000.77± 0.13

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Estimate Comment	Non-Inferiority Type
OG000	Linear mixed models estimated overall, within-person change across all 4 time points.	Mixed Models Analysis		0.068								Superiority
OG000	Linear mixed models estimated within-person change between baseline and day of surgery.	Mixed Models Analysis		0.043	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	0.03	Standard Error of the Mean	0.02	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change between baseline and 90 days postop.	Mixed Models Analysis		0.092	The null hypothesis was rejected a priori if p<.05.	Mean Difference (Net)	0.04	Standard Error of the Mean	0.02	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority
OG000	Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.	Mixed Models Analysis	The null hypothesis was rejected a priori if p<.05.	0.292		Mean Difference (Net)	0.02	Standard Error of the Mean	0.02	2-Sided	The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.	Superiority

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Linear mixed models estimated overall, within-person change across both time points.	Mixed Models Analysis		0.625														Superiority

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms