Piloting Prehabilitation Before Abdominal Surgery

Frailty Clinical Trial

Official title:

Pilot Testing Prehabilitation Services Aimed at Improving Outcomes of Frail Veterans Following Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040336
• Other study ID #: PPO 16-335
• Secondary ID: HX-002345
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 28, 2018

Study information

• Verified date: March 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 28, 2018
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• Prehabilitation
The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative Mortality	Postoperative mortality	30 and 90 days postoperatively
Other	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.	Baseline, day of surgery, 90-days postoperatively
Other	Quality of Surgical Care	AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.	Day of Surgery and 30-days postoperatively
Primary	Recruitment Rate	Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.	Baseline
Primary	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	Baseline
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.	Baseline to 90 days postoperatively
Primary	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.	Baseline to Day of Surgery
Secondary	Grip Strength	Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer	Baseline, day of surgery, 90 days postoperatively
Secondary	Pulmonary Function	Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.	Baseline, day of surgery, 90 days postoperatively
Secondary	Serum Prealbumin	Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.	Baseline, day of surgery, 90 days postoperatively
Secondary	Gait Speed	Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters.	Baseline, day of surgery, 90 days postoperatively
Secondary	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.	Baseline, day of surgery, 90 days postoperatively
Secondary	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.	Baseline, day of surgery, 90 days postoperatively
Secondary	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.	Baseline, day of surgery, 90 days postoperatively