Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Piloting Prehabilitation Before Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03040336
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Frailty Behavioral: Prehabilitation Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: Prehabilitation
Standard of care + Prehabilitation
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.

No Intervention: Standard of Care
Standard of Care



Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: Baseline ]
    Recruitment will be expressed as the proportion of eligible patients approached who agree to participate in this pilot study.

  2. Randomization Rate [ Time Frame: Baseline ]
    Randomization rate will be expressed as the proportion of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions

  3. Retention Rate [ Time Frame: Baseline to 90 days postoperatively ]
    Retention rate will be expressed as the proportion 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.

  4. Compliance Rate [ Time Frame: Baseline to Day of Surgery ]
    Compliance rates will be expressed as the proportion of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.


Secondary Outcome Measures :
  1. Grip Strength [ Time Frame: Baseline, day of surgery, 90 days postoperatively ]
    Grip strength will be measured in pounds using a Jamar grip dynamometer

  2. pulmonary function [ Time Frame: Baseline, day of surgery, 90 days postoperatively ]
    Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures

  3. Serum Prealbumin [ Time Frame: Baseline, day of surgery, 90 days postoperatively ]
    Nutrition will be measured by serum prealbumin.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Other Outcome Measures:
  1. Postoperative Mortality [ Time Frame: 30 and 90 days postoperatively ]
    Postoperative mortality

  2. Postoperative Complications [ Time Frame: 30-days postoperatively ]
    Presence or absence of postoperative complications as defined by the VA Surgical Quality Improvement Program

  3. length of hospital stay [ Time Frame: 30 day postoperatively ]
    length of stay as defined by the VASQIP

  4. Health Related Quality of Life [ Time Frame: Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively ]
    Assessment of Quality of Life (AQoL-6D)

  5. Quality of Surgical Care [ Time Frame: Day of Surgery and 30-days postoperatively ]
    AHRQ Surgical Care Survey (SCS)

  6. Living Location_survey [ Time Frame: Baseline, day of surgery, 30-days post op, 90-days post op ]
    Living location (e.g., home and independent, home with assistance, assisted living, skilled nursing, nursing home, etc).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Daniel E. Hall, MD MDiv MHSc VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03040336     History of Changes
Other Study ID Numbers: PPO 16-335
HX-002345 ( Other Grant/Funding Number: VA ORD HSR&D )
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
surgery
prehabilitation
exercise therapy
nutrition support

Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Pathologic Processes