Piloting Prehabilitation Before Abdominal Surgery
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|ClinicalTrials.gov Identifier: NCT03040336|
Recruitment Status : Completed
First Posted : February 2, 2017
Results First Posted : March 10, 2020
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Frailty||Behavioral: Prehabilitation||Not Applicable|
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:
- Estimate rates of recruitment, randomization, retention, and compliance with the prehabilitation intervention;
- 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Testing Prehabilitation Services Aimed at Improving Outcomes of Frail Veterans Following Major Abdominal Surgery|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||December 28, 2018|
|Actual Study Completion Date :||December 28, 2018|
Standard of care + Prehabilitation
The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
No Intervention: Standard of Care
Standard of Care
- Recruitment Rate [ Time Frame: Baseline ]Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
- Randomization Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Grip Strength [ Time Frame: Baseline, day of surgery, 90 days postoperatively ]Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer
- Pulmonary Function [ Time Frame: Baseline, day of surgery, 90 days postoperatively ]Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.
- Serum Prealbumin [ Time Frame: 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.
- Gait Speed [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
- 7-point Subjective Global Assessment of Nutrition_questionnaire [ Time Frame: 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.
- Postoperative Mortality [ Time Frame: 30 and 90 days postoperatively ]Postoperative mortality
- Health Related Quality of Life [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040336
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Daniel E. Hall, MD MDiv MHSc||VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|