Piloting Prehabilitation Before Abdominal Surgery

NCT03040336 | Completed Results

• 2 other identifiers: PPO 16-335HX-002345
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

surgery; prehabilitation; exercise therapy; nutrition support

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

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

  Baseline

• 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

• 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

• 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 Outcomes (7)

• Grip Strength

  Baseline, day of surgery, 90 days postoperatively

• Pulmonary Function

  Baseline, day of surgery, 90 days postoperatively

• Serum Prealbumin

  Baseline, day of surgery, 90 days postoperatively

• Gait Speed

  Baseline, day of surgery, 90 days postoperatively

• Short Physical Performance Battery (SPPB)

  Baseline, day of surgery, 90 days postoperatively

Other Outcomes (3)

• Postoperative Mortality

  30 and 90 days postoperatively

• Health Related Quality of Life

  Baseline, day of surgery, 90-days postoperatively

• Quality of Surgical Care

  Day of Surgery and 30-days postoperatively

Study Arms (2)

Prehabilitation

EXPERIMENTAL

Standard of care + Prehabilitation

Behavioral: Prehabilitation

Standard of Care

NO INTERVENTION

Standard of Care

Interventions

Prehabilitation BEHAVIORAL

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

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Daniel E Hall
• Organization: Pittsburgh VA Healthcare System, CHERP

daniel.hall2@va.gov

4123602016

Study Officials

• Daniel E. Hall, MD MDiv MHSc

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: February 2, 2017
• Study Start: February 1, 2017
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: March 10, 2020
• Results First Posted: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)