NCT06518369

Brief Summary

The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. A group of 10 patients will take part in a prehabilitation program. These patients will be compared to 20 patients who received standard of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2025

Completed
Last Updated

June 8, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

July 10, 2024

Last Update Submit

June 4, 2025

Conditions

Keywords

Frailty

Outcome Measures

Primary Outcomes (2)

  • Postoperative hospital length of stay

    Number of days in hospital from date of surgery to date of discharge

    From date of hospitalization until date of hospital discharge, up to 30 days

  • Discharge disposition

    Binary measure of either home or rehabilitation facility

    From date of hospitalization until date of hospital discharge, up to 30 days

Secondary Outcomes (2)

  • Adverse outcomes after surgery

    30 days after surgery

  • Hospital readmission rates

    30 days after surgery

Study Arms (2)

Non-intervention or standard of care group

20 Patients who received standard of care

Prehabilitation Group

10 patients who take part in a prehabilitation program for 4-6 weeks before surgery

Other: Prehabilitation

Interventions

Prehabilitation program for 4-6 weeks before surgery will include: * Review of the frailty risk analysis calculator score obtained in the frailty study (#2212-74) * Review of lab results including complete blood count, creatinine, albumin, and prealbumin * Review of chronic conditions. * An office visit or telehealth visit to review instructions on instructions on nutrition, exercise, smoking cessation, and optimization of chronic disease. * Drinking surgery immunonutrition drinks twice daily for 5 days before surgery. * Educational information and video instruction * Weekly phone calls to motivate, ensure adherence, and assess progress. * Measurements of hand grip strength and body weight

Prehabilitation Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects over age 60 who require elective major abdominal surgery

You may qualify if:

  • Subjects over age 60 who require elective major abdominal surgery

You may not qualify if:

  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nancy Georgetson, AGNP-C

    Robert Packer Hospital Sayre PA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 24, 2024

Study Start

June 18, 2024

Primary Completion

October 16, 2024

Study Completion

June 4, 2025

Last Updated

June 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations