Frailty
Conditions
Keywords
surgery, prehabilitation, exercise therapy, 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. We believe that similar improvements may be obtained by using similar interventions before surgery to prehabilitate patients' capacity to tolerate the stress of surgery. The proposed research will examine the feasibility of a new, prehabilitation intervention aimed at improving postoperative surgical outcomes through preoperative exercise training and nutritional supplementation. Findings from the study will inform the design of a larger randomized controlled trial of the prehabilitation intervention. If proven effective, prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery each year.
Detailed description
Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgeons operate safely on even the oldest old, if the elder is also frail, the stress of surgery can result in significant mortality, morbidity, and institutionalization. Frailty is a clinical syndrome marked by muscle atrophy, diminished strength, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age, and is a more powerful predictor of increased perioperative mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US populations grow older and more frail, it is critically important to identify effective strategies for improving the surgical outcomes of these patients. Prehabilitation has the potential to improve surgical outcomes among the frail. Prior research demonstrates that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength, improving nutrition, and optimizing home supports. Based on this success, there is growing interest in deploying similar interventions before surgery in what some call prehabilitation. By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of both surgery and recovery. Frail patients will likely benefit disproportionately from prehabilitation because they have the most diminished capacity to adapt to the stress of surgery. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations. Objectives: We will examine the feasibility of a novel, multifaceted pre-habilitation intervention aimed at improving postoperative outcomes for frail Veterans undergoing major abdominal surgery. Specific aims are to: 1. Estimate rates of recruitment, randomization, retention, and compliance with the prehabilitation intervention; 2. Measure (a) physical performance, (b) pulmonary function, and (c) nutrition at baseline and 2-week intervals to estimate changes over time and explore the optimal duration of prehabilitation (2 vs. 4 vs. 6 weeks); and 3. Estimate overall and treatment-specific summary statistics for postoperative outcomes in terms of 30- and 90-day (a) mortality, (b) major complications, (c) length of hospital stay, (d) health-related quality of life, (e) quality of surgical care, and (f) change in level of independent living. Methods: This randomized pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major abdominal surgery on the general or urological surgery services at the VA Pittsburgh Healthcare System. We will randomize participants 1:1 to receive either: (1) standard preoperative optimization by the Interdisciplinary Medical Preoperative Assessment Consultation & Treatment Clinic (IMPACT), or (2) prehabilitation + standard IMPACT optimization. The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation. Assessments will include standard postoperative outcomes as well as the Short Physical Performance Battery to measure physical performance, Maximal Inspiratory Pressure to measure pulmonary function, and both prealbumin and the 7-point Subjective Global Assessment to measure nutrition. Outcomes will be assessed 30 or 90 days after surgery. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform the development of a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the as many as 42,000 frail Veterans scheduled for major elective surgery each year.
Interventions
The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
Sponsors
Study design
Eligibility
Inclusion criteria
* Frail as defined by an Risk Analysis Index (RAI) score \>=16 * Scheduled for Major Abdominal Surgery as defined by a procedure that plans to violate the peritoneum or retroperitoneum (excluding inguinal hernias)
Exclusion criteria
* Unable to participate in planned Prehabilitation regimen * Surgery is cancelled by IMPACT clinic or surgeon due to unacceptable risk * Left ventricular ejection fractions \<35% * Severe valvular heart disease * Significant arrhythmia * Cognitive impairments that necessitate surrogate informed consent for the planned surgery * Unable to speak English
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. |
| Randomization Rate | Baseline | Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions |
| Retention Rate | Baseline to 90 days postoperatively | Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively. |
| Compliance Rate | Baseline to Day of Surgery | Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7-point Subjective Global Assessment of Nutrition_questionnaire | Baseline, day of surgery, 90 days postoperatively | This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment. |
| Gait Speed | Baseline, day of surgery, 90 days postoperatively | Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters. |
| Short Physical Performance Battery (SPPB) | Baseline, day of surgery, 90 days postoperatively | This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance. |
| Risk Analysis Index of Frailty (RAI)_questionnaire | Baseline, day of surgery, 90 days postoperatively | This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes. |
| Grip Strength | Baseline, day of surgery, 90 days postoperatively | Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer |
| Pulmonary Function | Baseline, day of surgery, 90 days postoperatively | Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures. |
| Serum Prealbumin | Baseline, day of surgery, 90 days postoperatively | Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life | Baseline, day of surgery, 90-days postoperatively | Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life. |
| Quality of Surgical Care | Day of Surgery and 30-days postoperatively | AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication. |
| Postoperative Mortality | 30 and 90 days postoperatively | Postoperative mortality |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prehabilitation Standard of care + Prehabilitation
Prehabilitation: The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation. | 10 |
| Standard of Care Patient received the standard hospital care | 7 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Prehabilitation | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 6 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 75.22 years STANDARD_DEVIATION 7.48 | 71.71 years STANDARD_DEVIATION 11.08 | 73.69 years STANDARD_DEVIATION 7.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 7 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 5 Participants | 13 Participants |
| Region of Enrollment United States | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 10 | 0 / 7 |
| other Total, other adverse events | 0 / 10 | 0 / 7 |
| serious Total, serious adverse events | 3 / 10 | 2 / 7 |
Outcome results
Compliance Rate
Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions.
Time frame: Baseline to Day of Surgery
Population: The compliance rate is only calculated for the prehabilitation arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Approached | Compliance Rate | Home exercise log | 56 percentage of completed activities | Standard Deviation 42.74 |
| Approached | Compliance Rate | Nutrition log | 10 percentage of completed activities | Standard Deviation 31.62 |
| Approached | Compliance Rate | On site exercise sessions | 93.6 percentage of completed activities | Standard Deviation 7.6 |
Randomization Rate
Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions
Time frame: Baseline
Population: 17 participants were overall analyzed. 10 were randomized to prehab, 7 were randomized to standard of care.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached | Randomization Rate | 10 Participants |
| Standard of Care | Randomization Rate | 7 Participants |
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: 54 is the number of patients approached. Only 17 were consented and overall analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached | Recruitment Rate | 17 Participants |
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: Baseline to 90 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Approached | Retention Rate | 7 Participants |
| Standard of Care | Retention Rate | 4 Participants |
7-point Subjective Global Assessment of Nutrition_questionnaire
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 |
|---|---|---|---|---|
| Approached | 7-point Subjective Global Assessment of Nutrition_questionnaire | Baseline Subjective Global Assessment | 5.43 score on a scale | Standard Deviation 0.79 |
| Approached | 7-point Subjective Global Assessment of Nutrition_questionnaire | Day of Surgery Subjective Global Assessment | 5.14 score on a scale | Standard Deviation 1.07 |
| Approached | 7-point Subjective Global Assessment of Nutrition_questionnaire | 90 Day Subjective Global Assessment | 5.14 score on a scale | Standard Deviation 1.07 |
| Standard of Care | 7-point Subjective Global Assessment of Nutrition_questionnaire | Baseline Subjective Global Assessment | 6.4 score on a scale | Standard Deviation 0.55 |
| Standard of Care | 7-point Subjective Global Assessment of Nutrition_questionnaire | Day of Surgery Subjective Global Assessment | 6.00 score on a scale | Standard Deviation 0 |
| Standard of Care | 7-point Subjective Global Assessment of Nutrition_questionnaire | 90 Day Subjective Global Assessment | 6.33 score on a scale | Standard Deviation 0.58 |
Gait Speed
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 |
|---|---|---|---|---|
| Approached | Gait Speed | Baseline Gait Speed | 0.98 m/s | Standard Deviation 0.3 |
| Approached | Gait Speed | Day of Surgery Gait Speed | 1.00 m/s | Standard Deviation 0.17 |
| Approached | Gait Speed | 90 Day Gait Speed | 1.07 m/s | Standard Deviation 0.4 |
| Standard of Care | Gait Speed | Baseline Gait Speed | 1.54 m/s | Standard Deviation 0.55 |
| Standard of Care | Gait Speed | Day of Surgery Gait Speed | 1.07 m/s | Standard Deviation 0.15 |
| Standard of Care | Gait Speed | 90 Day Gait Speed | 1.21 m/s | Standard Deviation 0.2 |
Grip Strength
Grip strength will be measured in kilograms of pressure using a Jamar 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 |
|---|---|---|---|---|
| Approached | Grip Strength | Baseline | 26.38 kgf/cm2 | Standard Deviation 4.99 |
| Approached | Grip Strength | Day of Surgery | 29.00 kgf/cm2 | Standard Deviation 5.38 |
| Approached | Grip Strength | 90 days | 23.75 kgf/cm2 | Standard Deviation 4.23 |
| Standard of Care | Grip Strength | Baseline | 27.75 kgf/cm2 | Standard Deviation 11.19 |
| Standard of Care | Grip Strength | Day of Surgery | 32.00 kgf/cm2 | Standard Deviation 13.88 |
| Standard of Care | Grip Strength | 90 days | 33.63 kgf/cm2 | Standard Deviation 11.28 |
Pulmonary Function
Pulmonary function will be measured in terms of maximal inspiratory and 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 |
|---|---|---|---|---|
| Approached | Pulmonary Function | Baseline Max MIP | 66.00 cm of water | Standard Deviation 27.2 |
| Approached | Pulmonary Function | Day of Surgery Max MIP | 70.11 cm of water | Standard Deviation 29.75 |
| Approached | Pulmonary Function | 90 Day Max MIP | 63.17 cm of water | Standard Deviation 32 |
| Approached | Pulmonary Function | Baseline Max MEP | 90.60 cm of water | Standard Deviation 34.97 |
| Approached | Pulmonary Function | Day of Surgery Max MEP | 108.67 cm of water | Standard Deviation 35.22 |
| Approached | Pulmonary Function | 90 Day Max MEP | 97.67 cm of water | Standard Deviation 30.5 |
| Standard of Care | Pulmonary Function | Day of Surgery Max MEP | 112.33 cm of water | Standard Deviation 35.64 |
| Standard of Care | Pulmonary Function | Baseline Max MIP | 79.33 cm of water | Standard Deviation 30.81 |
| Standard of Care | Pulmonary Function | Baseline Max MEP | 114.67 cm of water | Standard Deviation 41.56 |
| Standard of Care | Pulmonary Function | Day of Surgery Max MIP | 90.00 cm of water | Standard Deviation 19.97 |
| Standard of Care | Pulmonary Function | 90 Day Max MEP | 102.75 cm of water | Standard Deviation 19.48 |
| Standard of Care | Pulmonary Function | 90 Day Max MIP | 100.00 cm of water | Standard Deviation 11.53 |
Risk Analysis Index of Frailty (RAI)_questionnaire
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 |
|---|---|---|---|---|
| Approached | Risk Analysis Index of Frailty (RAI)_questionnaire | Day of Surgery RAI | 27.86 score on a scale | Standard Deviation 12.79 |
| Approached | Risk Analysis Index of Frailty (RAI)_questionnaire | Baseline RAI | 31.57 score on a scale | Standard Deviation 11.86 |
| Approached | Risk Analysis Index of Frailty (RAI)_questionnaire | 90 Day RAI | 29.00 score on a scale | Standard Deviation 10.39 |
| Standard of Care | Risk Analysis Index of Frailty (RAI)_questionnaire | Day of Surgery RAI | 29.00 score on a scale | Standard Deviation 5.66 |
| Standard of Care | Risk Analysis Index of Frailty (RAI)_questionnaire | Baseline RAI | 24.75 score on a scale | Standard Deviation 0.5 |
| Standard of Care | Risk Analysis Index of Frailty (RAI)_questionnaire | 90 Day RAI | 26.67 score on a scale | Standard Deviation 2.89 |
Serum Prealbumin
Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.
Time frame: Baseline, day of surgery, 90 days postoperatively
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 |
|---|---|---|---|---|
| Approached | Serum Prealbumin | Baseline Prealbumin | 26.5 mg/dL | Standard Deviation 4.93 |
| Approached | Serum Prealbumin | Day of Surgery Prealbumin | 22.5 mg/dL | Standard Deviation 6.36 |
| Approached | Serum Prealbumin | 90 Day Prealbumin | 23.6 mg/dL | Standard Deviation 8.44 |
| Standard of Care | Serum Prealbumin | Baseline Prealbumin | 29 mg/dL | Standard Deviation 2.83 |
| Standard of Care | Serum Prealbumin | Day of Surgery Prealbumin | 25.5 mg/dL | Standard Deviation 2.12 |
| Standard of Care | Serum Prealbumin | 90 Day Prealbumin | 22 mg/dL | Standard Deviation 0 |
Short Physical Performance Battery (SPPB)
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 |
|---|---|---|---|---|
| Approached | Short Physical Performance Battery (SPPB) | Baseline SPPB | 9.13 score on a scale | Standard Deviation 2.3 |
| Approached | Short Physical Performance Battery (SPPB) | Day of Surgery SPPB | 10.56 score on a scale | Standard Deviation 0.88 |
| Approached | Short Physical Performance Battery (SPPB) | 90 Day SPPB | 9.8 score on a scale | Standard Deviation 1.79 |
| Standard of Care | Short Physical Performance Battery (SPPB) | Baseline SPPB | 10.6 score on a scale | Standard Deviation 1.52 |
| Standard of Care | Short Physical Performance Battery (SPPB) | Day of Surgery SPPB | 11 score on a scale | Standard Deviation 0 |
| Standard of Care | Short Physical Performance Battery (SPPB) | 90 Day SPPB | 10.75 score on a scale | Standard Deviation 0.96 |
Health Related Quality of Life
Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.
Time frame: Baseline, day of surgery, 90-days postoperatively
Population: Not all participants were analyzed, because this measure requires participants to complete the questionnaire and not all participants did.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Approached | Health Related Quality of Life | Baseline | 0.72 score on a scale | Standard Deviation 0.09 |
| Approached | Health Related Quality of Life | Day of Surgery | 0.68 score on a scale | Standard Deviation 0.08 |
| Approached | Health Related Quality of Life | 90-days postoperative | 0.75 score on a scale | Standard Deviation 0.09 |
| Standard of Care | Health Related Quality of Life | Baseline | 0.67 score on a scale | Standard Deviation 0.05 |
| Standard of Care | Health Related Quality of Life | Day of Surgery | 0.77 score on a scale | Standard Deviation 0.01 |
| Standard of Care | Health Related Quality of Life | 90-days postoperative | 0.80 score on a scale | Standard Deviation 0.07 |
Postoperative Mortality
Postoperative mortality
Time frame: 30 and 90 days postoperatively
Population: The mortality questionnaire was completed for all participants still enrolled in the study at the indicated time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Approached | Postoperative Mortality | 30-days mortality | 0 Participants |
| Approached | Postoperative Mortality | 90-days mortality | 1 Participants |
| Standard of Care | Postoperative Mortality | 30-days mortality | 0 Participants |
| Standard of Care | Postoperative Mortality | 90-days mortality | 0 Participants |
Quality of Surgical Care
AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.
Time frame: Day of Surgery and 30-days postoperatively
Population: All participants that completed the assessment were analyzed at each completed timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Approached | Quality of Surgical Care | 30-days Total Communication | 1.25 score on a scale | Standard Deviation 0.29 |
| Approached | Quality of Surgical Care | Day of Surgery Total Communication | 1.33 score on a scale | Standard Deviation 0.37 |
| Standard of Care | Quality of Surgical Care | Day of Surgery Total Communication | 1.13 score on a scale | Standard Deviation 0.18 |
| Standard of Care | Quality of Surgical Care | 30-days Total Communication | 1.19 score on a scale | Standard Deviation 0.24 |