Clinical trial NCT03040336: Piloting Prehabilitation Before Abdominal Surgery
Official title: Pilot Testing Prehabilitation Services Aimed at Improving Outcomes of Frail Veterans Following Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: surgery
prehabilitation
exercise therapy
nutrition support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-02-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: Baseline
measure: Randomization Rate
timeFrame: Baseline
measure: Retention Rate
timeFrame: Baseline to 90 days postoperatively
measure: Compliance Rate
timeFrame: Baseline to Day of Surgery
Secondary outcomes:
measure: Grip Strength
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Pulmonary Function
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Serum Prealbumin
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Gait Speed
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: Risk Analysis Index of Frailty (RAI)_questionnaire
timeFrame: Baseline, day of surgery, 90 days postoperatively
measure: 7-point Subjective Global Assessment of Nutrition_questionnaire
timeFrame: Baseline, day of surgery, 90 days postoperatively
Other outcomes:
measure: Postoperative Mortality
timeFrame: 30 and 90 days postoperatively
measure: Health Related Quality of Life
timeFrame: Baseline, day of surgery, 90-days postoperatively
measure: Quality of Surgical Care
timeFrame: Day of Surgery and 30-days postoperatively
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Daniel E. Hall, MD MDiv MHSc
role: PRINCIPAL_INVESTIGATOR
References: