Frailty and Muscle Strength Tests in Older Adults Undergoing Major Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

The goal of this observational study is to learn if simple tests for frailty and muscle strength can help predict which older adults (age 65 and older) are at higher risk for problems after major abdominal surgery.

The main questions it aims to answer are:

* Do measures of frailty and muscle strength, taken before surgery, predict complications after surgery? * Can these tests be easily done during a routine pre-surgical visit?

Participants will:

* Complete brief tests measuring muscle strength, breathing strength, physical function, nutrition status, body composition, and memory during a regular pre-surgical clinic appointment. * Allow researchers to review their medical records 30 and 90 days after surgery to identify any complications or health problems.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Participants will be older adults (age 65 or older) undergoing planned major abdominal surgeries at the University of North Carolina (UNC) Medical Center. Patients will typically be recruited from the UNC Preoperative Anesthesia Clinic, where standard preoperative assessments are performed.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Frailty assessment, nutrition assessment, cognition assessment, muscle strength testing

    Diagnostic test

    Participants will undergo a structured frailty and muscle-strength assessment battery performed during their routine preoperative evaluation. These assessments serve as the primary exposure measures of interest and include: Clinical Frailty Scale (CFS) evaluation (functional frailty assessment) Respiratory muscle strength assessment (Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) using a MicroRPM handheld respiratory pressure meter) Hand-grip strength measurement (using Jamar dynamometer) Physical performance evaluation (Timed Up-and-Go (TUG) test) Skeletal muscle mass estimation (Bioelectrical impedance analysis, InBody 120) Muscle thickness measurement (Rectus femoris muscle thickness using portable ultrasound) Cognitive function screening (Mini-Cog test) Nutritional risk screening (Perioperative Nutrition Screen \[PONS\]) No additional interventions beyond these observational assessments will be conducted.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Feasibility of Frailty Assessment Integration

Percentage of participants successfully completing the entire frailty assessment battery within a 20-minute target during routine preoperative visits.

Time frame
At the time of the preoperative assessment
2

Predictive Capability of Frailty Measures for Postoperative Complications

Association between preoperative frailty measures (Clinical Frailty Scale, muscle strength tests, respiratory pressure tests, physical function, cognitive screening, nutritional status, and ultrasound-based muscle thickness) and occurrence of postoperative complications at 30 and 90 days.

Time frame
30 and 90 days postoperatively

Secondary outcomes

Other outcomes

Sponsors and contacts

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