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CompletedNCT03299101Updated Jan 13, 2021Results posted

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

An interventional study of Prehabilitation in Coronary Artery Bypass Graft, Non-cardiac Thoracic Surgery and Frailty, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-01-13.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Bypass Graft
  • Non-cardiac Thoracic Surgery
  • Frailty

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Keywords

  • Frailty
  • Prehabilitation
  • Exercise therapy
  • Surgery
  • Nutrition support
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Veteran patient scheduled for Coronary artery bypass graft (CABG), valve surgery, or other non-cardiac thoracic surgery;
  2. Demonstrate at least mild frailty (e.g., Risk Analysis Index [RAI]>=16).
  3. Physician/provider request for patients with RAI\<16.

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Prehabilitation

    Prospective sample of patients anticipating cardiothoracic surgery.

    Other: Prehabilitation

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.

05

What researchers measure

Primary outcomes

  1. Recruitment Rate

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

    Time frame: Baseline

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Other outcomes

  1. 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

06

Results

Posted Dec 21, 2020

Participant flow

Participant flow — Overall Study
MilestonePrehabilitation
Started35
Completed25
Not completed10
Withdrew: Lost to follow-up1
Withdrew: Withdrawal by subject5
Withdrew: Surgery was changed3
Withdrew: Not enough time to complete prehab1

Outcome measures

PrimaryRecruitment Rate

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

Time frame:
Baseline
Reported as:
Count of participants · Participants
Recruitment Rate
ParticipantsPrehabilitation
Recruitment Rate35
PrimaryRetention 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
Reported as:
Count of participants · Participants
Retention Rate
ParticipantsPrehabilitation
Retention Rate25
PrimaryAdherence 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
Reported as:
Mean · percentage of activities completed
Adherence Rate
percentage of activities completedPrehabilitation
Home Strength/Aerobic/Transition Training78.85 ± 28.96
Home Breathing Training86.30 ± 24.20
Home Nutrition Log64.09 ± 14.10
SecondaryChange 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
Reported as:
Mean · kgf/cm2
Change in Grip Strength Over the Course of Treatment and Recovery.
kgf/cm2Prehabilitation
Baseline Grip Strength31.52 ± 9.27
Day of Surgery Grip Strength32.19 ± 7.89
90 Days Post Surgery31.13 ± 9.99
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.872
  • Prehabilitation · Mixed Models Analysis · p = 0.423 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 0.57The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.853 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -0.39The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.552 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -1.28The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · cm of H2O
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
cm of H2OPrehabilitation
Baseline Max MIP71.42 ± 24.54
Day of surgery Max MIP77.96 ± 24.23
90 Day Postop Max MIP79.82 ± 26.86
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.256 (The null hypothesis was rejected a priori if p\<.05.)
  • Prehabilitation · Mixed Models Analysis · p = 0.091 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 4.69The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.066 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 6.80The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.552 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 1.86The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · cm of H2O
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
cm of H2OPrehabilitation
Baseline Mean MIP60.69 ± 23.57
Day of surgery Mean MIP69.38 ± 23.11
90 Day Postop Mean MIP71.43 ± 26.10
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.003 (The null hypothesis was rejected a priori if p\<.05.)
  • Prehabilitation · Mixed Models Analysis · p = 0.003 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 7.48The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.005 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 10.18The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.290 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 2.31The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · cm of H2O
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
cm of H2OPrehabilitation
Baseline Max MEP108.09 ± 33.64
Day of surgery Max MEP120.81 ± 30.40
90 Day Postop Max MEP123.64 ± 32.64
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.009 (The null hypothesis was rejected a priori if p\<.05.)
  • Prehabilitation · Mixed Models Analysis · p = 0.006 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 12.61The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.015 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 12.79The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.802 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -0.86The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · cm of H2O
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
cm of H2OPrehabilitation
Baseline Mean MEP98.48 ± 32.90
Day of surgery Mean MEP111.22 ± 28.62
90 Day Postop Mean MEP112.01 ± 31.72
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.010 (The null hypothesis was rejected a priori if p\<.05.)
  • Prehabilitation · Mixed Models Analysis · p = 0.004 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 12.37The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.042 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 9.95The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.221 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -3.77The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · cm of H2O
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
cm of H2OPrehabilitation
Baseline Max SMIP416.55 ± 197.85
Day of surgery Max SMIP434.48 ± 192.42
90 Day Postop Max SMIP466.77 ± 197.27
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.814
  • Prehabilitation · Mixed Models Analysis · p = 0.734 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 10.50The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.341 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 21.07The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.448 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 28.55The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · cm of H2O
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
cm of H2OPrehabilitation
Baseline Mean SMIP364.36 ± 171.33
Day of surgery Mean SMIP393.86 ± 185.85
90 Day Postop Mean SMIP435.94 ± 202.14
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.419
  • Prehabilitation · Mixed Models Analysis · p = 0.439 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 20.91The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.069 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 47.67The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.328 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 37.11The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondarySerum 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
Reported as:
Mean · mg/dL
Serum Prealbumin Over the Course of Treatment and Recovery
mg/dLPrehabilitation
Baseline Serum Prealbumin26.27 ± 5.57
Day of surgery Serum Prealbumin26.50 ± 4.52
90 Day Postop Serum Prealbumin25.13 ± 6.48
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.196
  • Prehabilitation · Mixed Models Analysis · p = 0.562 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -0.11The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.087 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -0.42The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.226 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -0.28The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · m/s
Change in Gait Speed Over the Course of Treatment and Recovery
m/sPrehabilitation
Baseline Gait Speed1.16 ± 0.32
Day of surgery Gait Speed1.33 ± 0.28
90 Day Postop Gait Speed1.36 ± 0.37
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.001
  • Prehabilitation · Mixed Models Analysis · p = 0.001 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 0.12The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.001 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 0.16The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests
  • Prehabilitation · Mixed Models Analysis · p = 0.874 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 0.01The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · score on a scale
Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
score on a scalePrehabilitation
Baseline SPPB10.44 ± 1.74
Day of surgery SPPB10.83 ± 1.17
90 Day Postop SPPB10.64 ± 1.94
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.854
  • Prehabilitation · Mixed Models Analysis · p = 0.298 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 0.33The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.684 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 0.13The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.485 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -0.23The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · score on a scale
Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
score on a scalePrehabilitation
Baseline RAI17.85 ± 8.92
Day of surgery RAI20.40 ± 8.69
90 Day Postop RAI23.30 ± 9.16
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.067
  • Prehabilitation · Mixed Models Analysis · p = 0.089 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 2.07The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.006 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 4.37The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.221 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 1.98The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · score on a scale
Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
score on a scalePrehabilitation
Baseline SGA6.04 ± 0.60
Day of Surgery SGA6.00 ± 0.33
90 Day Postop SGA5.95 ± 0.59
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.860
  • Prehabilitation · Mixed Models Analysis · p = 0.410 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -0.10The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.622 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -0.09The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.757 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): -0.05The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · meters
Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
metersPrehabilitation
Baseline 6 Minute Walk Distance366.49 ± 108.68
Day of Surgery 6 Minute Walk Distance400.33 ± 101.07
90 Day Postop 6 Minute Walk Distance386.96 ± 94.70
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.362
  • Prehabilitation · Mixed Models Analysis · p = .203 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 25.52The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.357 (The null hypothesis was rejected a priori if p\<0.05.) · Mean difference (net): 12.70The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.163 (The null hypothesis was rejected a priori if p\<0.05.) · Mean difference (net): 21.48The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
SecondaryChange 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
Reported as:
Mean · score on a scale
Change in Health Related Quality of Life Over the Course of Treatment and Recovery
score on a scalePrehabilitation
Baseline AQoL6D Utility Score0.72 ± 0.16
Day of surgery AQoL6D Utility Score0.75 ± 0.13
90 Day Postop AQoL6D Utility Score0.77 ± 0.13
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.068
  • Prehabilitation · Mixed Models Analysis · p = 0.043 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 0.03The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.092 (The null hypothesis was rejected a priori if p\<.05.) · Mean difference (net): 0.04The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
  • Prehabilitation · Mixed Models Analysis · p = 0.292 · Mean difference (net): 0.02The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.
Other pre-specifiedChange 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
Reported as:
Mean · score on a scale
Change in Quality of Surgical Care Over the Course of Treatment and Recovery
score on a scalePrehabilitation
Day of surgery Total Communication1.08 ± 0.16
30 Day Postop Total Communication1.13 ± 0.43
Statistical analysis
  • Prehabilitation · Mixed Models Analysis · p = 0.625

Adverse events

Collected over Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Prehabilitation0/35 (0%)7/35 (20%)0/35 (0%)
Most frequent serious events
Most frequent serious events
EventPrehabilitation
Orthostatic HypotensionBlood and lymphatic system disorders1/35
Suspected ischemic strokeVascular disorders1/35
Unrelated inpatient hospitalizationGeneral disorders1/35
DetoxGeneral disorders1/35
Unrelated inpatient hospitalizationRespiratory, thoracic and mediastinal disorders1/35
Post-operative pain unrealted inpatient hospitalizationInjury, poisoning and procedural complications1/35
Second unexpect surgerySurgical and medical procedures1/35

Baseline characteristics

All participants that completed the baseline assessments were analyzed.

Age, Categorical
Age, Categorical(Participants)Prehabilitation
<=18 years0
Between 18 and 65 years11
>=65 years22
Age, Continuous
Age, Continuous(years)Prehabilitation
Mean66.09 ± 7.66
Sex: Female, Male
Sex: Female, Male(Participants)Prehabilitation
Female2
Male31
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Prehabilitation
Hispanic or Latino0
Not Hispanic or Latino33
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Prehabilitation
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White31
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Prehabilitation
United States33
Risk Analysis Index
Risk Analysis Index(Score on a scale)Prehabilitation
Mean17.85 ± 8.92
07

Study locations

1 site
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    Pittsburgh, Pennsylvania 15240, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 24, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03299101
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Oct 2, 2017
Start date
Nov 22, 2017
Primary completion
Apr 30, 2020
Completion
Sep 30, 2020
Results posted
Dec 21, 2020
Last update
Jan 13, 2021

Study contacts

Daniel E. Hall, MD MDiv MHSc
principal investigator · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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