Frailty and Muscle Strength Tests in Older Adults Undergoing Major Surgery

NCT06988176 | Recruiting

• 1 other identifier: 25-0481
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Muscle Strength; Post Operative Complications; Nutrition Assessment; Risk Assessment; Elderly (People Aged 65 or More); Hand Strength; Frailty; Sarcopenia in Elderly

Keywords

Frailty; sarcopenia; elective abdominal surgery; Muscle strength; Hand Strength; Inspiratory muscle strength; Post operative complications; Risk Assessment; Nutrition Assessment; Elderly patients; Cognitive Function; Physical functional performance

Outcome Measures

Primary Outcomes (2)

• Feasibility of Frailty Assessment Integration

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

  At the time of the preoperative assessment

• 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.

  30 and 90 days postoperatively

Interventions

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Frailty; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Monika Nanda, MBBS, MPH, FASA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: June 19, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication.
• Access Criteria: Data requests should include a clear scientific rationale and intended use. Requests will be reviewed by the principal investigator and the research team for approval. Approved researchers must sign a data-sharing agreement committing to protect participant confidentiality and use data solely for approved scientific purposes. Data will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Locations

US (1)