Frailty and muscle-strength testing for older adults having major abdominal surgery
Feasibility and Correlation of Functional Muscle Strength Tests and Objective Frailty Measures With Clinical Frailty Scale in Patients Undergoing Major Surgery
We will test whether brief frailty and muscle-strength tests done before surgery can help predict which people aged 65 and older are more likely to have problems after major abdominal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06988176 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls patients 65 years and older who are scheduled for elective major abdominal operations and performs a brief preoperative testing battery during a routine clinic visit. Tests include the Clinical Frailty Scale, hand-grip strength, timed up-and-go, respiratory pressure (MIP/MEP), bioimpedance-based skeletal muscle index, rectus femoris ultrasound, Mini-Cog, and a nutrition screen, taking about 20 minutes total. Trained research staff perform all measurements, and researchers review participant medical records at 30 and 90 days after surgery to identify complications and other outcomes. The goal is to determine whether these brief, objective measures can be feasibly incorporated into preoperative workflows and whether they predict postoperative complications.
Who should consider this trial
Good fit: People aged 65 or older who are scheduled for planned (non-emergency) major abdominal surgery and who can walk independently and complete brief physical and cognitive tests are ideal candidates.
Not a fit: Patients having emergency surgery, those unable to walk independently, or those with significant cognitive impairment preventing completion of the tests would not be eligible and are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify older patients at higher risk for postoperative problems so they can tailor perioperative care and plan interventions to reduce complications.
How similar studies have performed: Previous observational work has shown that individual measures such as grip strength, gait speed, and frailty scales often predict postoperative complications, though combining a brief multimodal battery into routine preoperative visits is less widely established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants may be eligible for this study if they meet the following conditions: * Age 65 years or older. * Scheduled for elective (planned, non-emergency) major abdominal surgery, including colorectal, hepatobiliary, gynecologic, or urologic procedures. * Able to attend a routine preoperative evaluation visit. * Able and willing to complete brief assessments for muscle strength, walking, breathing strength, memory, and nutrition. Exclusion Criteria: Participants will not be eligible for the study if they have any of the following conditions: * Surgery is an emergency procedure. * Unable to walk independently (for example, dependent on a wheelchair or bed-bound). * Significant cognitive impairment that prevents understanding or completing study tests.
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Monika Nanda, MBBS, MPH, FASA — University of North Carolina, Chapel Hill
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.