Coronary Artery Bypass Graft, Frailty, Non-cardiac Thoracic Surgery
Conditions
Keywords
Frailty, Prehabilitation, Exercise therapy, Surgery, Nutrition support
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.
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.
Interventions
OTHERPrehabilitation
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Baseline | Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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). |
| 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). |
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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). |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Not enough time to complete prehab | 1 |
| Overall Study | Surgery was changed | 3 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Prehabilitation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 22 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age, Continuous | 66.09 years STANDARD_DEVIATION 7.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Region of Enrollment United States | 33 Participants |
| Risk Analysis Index | 17.85 Score on a scale STANDARD_DEVIATION 8.92 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 7 / 35 |
Outcome results
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.
Time frame: Day of surgery
Population: All participants that self-reported their home training and/or showed their exercise or nutrition logs were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Adherence Rate | Home Nutrition Log | 64.09 percentage of activities completed | Standard Deviation 14.1 |
| Prehabilitation | Adherence Rate | Home Strength/Aerobic/Transition Training | 78.85 percentage of activities completed | Standard Deviation 28.96 |
| Prehabilitation | Adherence Rate | Home Breathing Training | 86.30 percentage of activities completed | Standard Deviation 24.2 |
Primary
Recruitment Rate
Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
Time frame: Baseline
Population: 65 is the number of patients approached.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prehabilitation | Recruitment Rate | 35 Participants |
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.
Time frame: 90 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prehabilitation | Retention Rate | 25 Participants |
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.
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the six minute walk test were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in 6 Minute Walk Test Over the Course of Treatment and Recovery | Baseline 6 Minute Walk Distance | 366.49 meters | Standard Deviation 108.68 |
| Prehabilitation | Change in 6 Minute Walk Test Over the Course of Treatment and Recovery | Day of Surgery 6 Minute Walk Distance | 400.33 meters | Standard Deviation 101.07 |
| Prehabilitation | Change in 6 Minute Walk Test Over the Course of Treatment and Recovery | 90 Day Postop 6 Minute Walk Distance | 386.96 meters | Standard Deviation 94.7 |
Comparison: Linear mixed models estimated overall, within-person change in 6 Minute Walk Test across all 4 time points.p-value: 0.362Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and day of surgery.p-value: 0.203Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and 90 days postop.p-value: 0.357Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in 6 Minute Walk Test between day of surgery and 90 days postop.p-value: 0.163Mixed Models Analysis
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.
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the Subjective Global Assessment were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery | Baseline SGA | 6.04 score on a scale | Standard Deviation 0.6 |
| Prehabilitation | Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery | Day of Surgery SGA | 6.00 score on a scale | Standard Deviation 0.33 |
| Prehabilitation | Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery | 90 Day Postop SGA | 5.95 score on a scale | Standard Deviation 0.59 |
Comparison: Linear mixed models estimated overall, within-person change in SGA across all 4 time points.p-value: 0.86Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in SGA between baseline and day of surgery.p-value: 0.41Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in SGA between baseline and 90 days postop.p-value: 0.622Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in SGA between day of surgery and 90 days postop.p-value: 0.757Mixed Models Analysis
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
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the gait speed assessment were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Gait Speed Over the Course of Treatment and Recovery | Baseline Gait Speed | 1.16 m/s | Standard Deviation 0.32 |
| Prehabilitation | Change in Gait Speed Over the Course of Treatment and Recovery | Day of surgery Gait Speed | 1.33 m/s | Standard Deviation 0.28 |
| Prehabilitation | Change in Gait Speed Over the Course of Treatment and Recovery | 90 Day Postop Gait Speed | 1.36 m/s | Standard Deviation 0.37 |
Comparison: Linear mixed models estimated overall, within-person change in gait speed across all 4 time points.p-value: 0.001Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in gait speed between baseline and day of surgery.p-value: 0.001Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in gait speed between baseline and 90 days postop.p-value: 0.001Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in gait speed between day of surgery and 90 days postop.p-value: 0.874Mixed Models Analysis
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
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the hand grip assessment were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Grip Strength Over the Course of Treatment and Recovery. | Baseline Grip Strength | 31.52 kgf/cm2 | Standard Deviation 9.27 |
| Prehabilitation | Change in Grip Strength Over the Course of Treatment and Recovery. | Day of Surgery Grip Strength | 32.19 kgf/cm2 | Standard Deviation 7.89 |
| Prehabilitation | Change in Grip Strength Over the Course of Treatment and Recovery. | 90 Days Post Surgery | 31.13 kgf/cm2 | Standard Deviation 9.99 |
Comparison: Linear mixed models estimated overall, within-person change in grip strength across all 4 time points.p-value: 0.872Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in grip strength between baseline and day of surgery.p-value: 0.423Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in grip strength between baseline and 90 days postop.p-value: 0.853Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in grip strength between day of surgery and 90 days postop.p-value: 0.552Mixed Models Analysis
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.
Time frame: Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively
Population: All participants that completed all of the AQoL6D assessment were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Health Related Quality of Life Over the Course of Treatment and Recovery | Baseline AQoL6D Utility Score | 0.72 score on a scale | Standard Deviation 0.16 |
| Prehabilitation | Change in Health Related Quality of Life Over the Course of Treatment and Recovery | Day of surgery AQoL6D Utility Score | 0.75 score on a scale | Standard Deviation 0.13 |
| Prehabilitation | Change in Health Related Quality of Life Over the Course of Treatment and Recovery | 90 Day Postop AQoL6D Utility Score | 0.77 score on a scale | Standard Deviation 0.13 |
Comparison: Linear mixed models estimated overall, within-person change across all 4 time points.p-value: 0.068Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change between baseline and day of surgery.p-value: 0.043Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change between baseline and 90 days postop.p-value: 0.092Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.p-value: 0.292Mixed Models Analysis
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)
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP | Baseline Max MEP | 108.09 cm of H2O | Standard Deviation 33.64 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP | Day of surgery Max MEP | 120.81 cm of H2O | Standard Deviation 30.4 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP | 90 Day Postop Max MEP | 123.64 cm of H2O | Standard Deviation 32.64 |
Comparison: Linear mixed models estimated overall, within-person change in maximal inspiratory pressure across all 4 time points.p-value: 0.009Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in maximum MEP between baseline and day of surgery.p-value: 0.006Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in maximum MEP between baseline and 90 days postop.p-value: 0.015Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in maximum MEP between day of surgery and 90 days postop.p-value: 0.802Mixed Models Analysis
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).
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP | Baseline Max MIP | 71.42 cm of H2O | Standard Deviation 24.54 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP | Day of surgery Max MIP | 77.96 cm of H2O | Standard Deviation 24.23 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP | 90 Day Postop Max MIP | 79.82 cm of H2O | Standard Deviation 26.86 |
Comparison: Linear mixed models estimated overall, within-person change in max MIP across all 4 time points.p-value: 0.256Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in maximum MIP between baseline and day of surgery.p-value: 0.091Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in maximum MIP between baseline and 90 days postop.p-value: 0.066Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in maximum MIP between day of surgery and 90 days postop.p-value: 0.552Mixed Models Analysis
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).
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP | Baseline Max SMIP | 416.55 cm of H2O | Standard Deviation 197.85 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP | Day of surgery Max SMIP | 434.48 cm of H2O | Standard Deviation 192.42 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP | 90 Day Postop Max SMIP | 466.77 cm of H2O | Standard Deviation 197.27 |
Comparison: Linear mixed models estimated overall, within-person change in max SMIP across all 4 time points.p-value: 0.814Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in maximum SMIP between baseline and day of surgery.p-value: 0.734Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in maximum SMIP between baseline and 90 days postop.p-value: 0.341Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in maximum SMIP between day of surgery and 90 days postop.p-value: 0.448Mixed Models Analysis
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).
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP | Baseline Mean MEP | 98.48 cm of H2O | Standard Deviation 32.9 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP | Day of surgery Mean MEP | 111.22 cm of H2O | Standard Deviation 28.62 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP | 90 Day Postop Mean MEP | 112.01 cm of H2O | Standard Deviation 31.72 |
Comparison: Linear mixed models estimated overall, within-person change in Mean MEP across all 4 time points.p-value: 0.01Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean MEP between baseline and day of surgery.p-value: 0.004Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean MEP between baseline and 90 days postop.p-value: 0.042Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.p-value: 0.221Mixed Models Analysis
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).
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP | Baseline Mean MIP | 60.69 cm of H2O | Standard Deviation 23.57 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP | Day of surgery Mean MIP | 69.38 cm of H2O | Standard Deviation 23.11 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP | 90 Day Postop Mean MIP | 71.43 cm of H2O | Standard Deviation 26.1 |
Comparison: Linear mixed models estimated overall, within-person change in mean MIP across all 4 time points.p-value: 0.003Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean MIP between baseline and day of surgery.p-value: 0.003Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean MIP between baseline and 90 days postop.p-value: 0.005Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean MIP between day of surgery and 90 days postop.p-value: 0.29Mixed Models Analysis
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).
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP | Baseline Mean SMIP | 364.36 cm of H2O | Standard Deviation 171.33 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP | Day of surgery Mean SMIP | 393.86 cm of H2O | Standard Deviation 185.85 |
| Prehabilitation | Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP | 90 Day Postop Mean SMIP | 435.94 cm of H2O | Standard Deviation 202.14 |
Comparison: Linear mixed models estimated overall, within-person change in mean SMIP across all 4 time points.p-value: 0.419Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean SMIP between baseline and day of surgery.p-value: 0.439Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean SMIP between baseline and 90 days postop.p-value: 0.069Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in mean SMIP between day of surgery and 90 days postop.p-value: 0.328Mixed Models Analysis
Secondary
Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
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
Population: All participants that completed the RAI assessment were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery | Baseline RAI | 17.85 score on a scale | Standard Deviation 8.92 |
| Prehabilitation | Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery | Day of surgery RAI | 20.40 score on a scale | Standard Deviation 8.69 |
| Prehabilitation | Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery | 90 Day Postop RAI | 23.30 score on a scale | Standard Deviation 9.16 |
Comparison: Linear mixed models estimated overall, within-person change in RAI across all 4 time points.p-value: 0.067Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in RAI between baseline and day of surgery.p-value: 0.089Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in RAI between baseline and 90 days postop.p-value: 0.006Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in RAI between day of surgery and 90 days postop.p-value: 0.221Mixed Models Analysis
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.
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: All participants that completed the SPPB assessments were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery | Baseline SPPB | 10.44 score on a scale | Standard Deviation 1.74 |
| Prehabilitation | Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery | Day of surgery SPPB | 10.83 score on a scale | Standard Deviation 1.17 |
| Prehabilitation | Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery | 90 Day Postop SPPB | 10.64 score on a scale | Standard Deviation 1.94 |
Comparison: Linear mixed models estimated overall, within-person change in SPPB across all 4 time points.p-value: 0.854Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in SPPB between baseline and day of surgery.p-value: 0.298Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in SPPB between baseline and 90 days postop.p-value: 0.684Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in SPPB between day of surgery and 90 days postop.p-value: 0.485Mixed Models Analysis
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
Time frame: Baseline, day of surgery, 90 days postoperatively
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Serum Prealbumin Over the Course of Treatment and Recovery | Baseline Serum Prealbumin | 26.27 mg/dL | Standard Deviation 5.57 |
| Prehabilitation | Serum Prealbumin Over the Course of Treatment and Recovery | Day of surgery Serum Prealbumin | 26.50 mg/dL | Standard Deviation 4.52 |
| Prehabilitation | Serum Prealbumin Over the Course of Treatment and Recovery | 90 Day Postop Serum Prealbumin | 25.13 mg/dL | Standard Deviation 6.48 |
Comparison: Linear mixed models estimated overall, within-person change in serum prealbumin across all 4 time points.p-value: 0.196Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in serum prealbumin between baseline and day of surgery.p-value: 0.562Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in serum prealbumin between baseline and 90 days postop.p-value: 0.087Mixed Models Analysis
Comparison: Linear mixed models estimated within-person change in serum prealbumin between day of surgery and 90 days postop.p-value: 0.226Mixed Models Analysis
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
Time frame: Day of Surgery and 30-days postoperatively
Population: All participants that completed the every question of the AHRQ SCS total communication section assessment were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prehabilitation | Change in Quality of Surgical Care Over the Course of Treatment and Recovery | Day of surgery Total Communication | 1.08 score on a scale | Standard Deviation 0.16 |
| Prehabilitation | Change in Quality of Surgical Care Over the Course of Treatment and Recovery | 30 Day Postop Total Communication | 1.13 score on a scale | Standard Deviation 0.43 |
Comparison: Linear mixed models estimated overall, within-person change across both time points.p-value: 0.625Mixed Models Analysis