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NCT Number: NCT07069777

Muscle Quality and Subcutaneous Adipose Tissue in the Rectus Femoris and Rectus Abdominis Muscles: Ultrasound Evaluation and Functional Correlation in Older Adults

The goal of this observational, cross-sectional study is to examine the relationship between body composition and muscle quality in women over the afe of 65. The main question it aims to answer is:

How are ultrasound-based measurements of muscle and fat tissue related to functional performance in older women?

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Key information

About this study

In this observational and cross-sectional study, researchers will use ultrasound imaging and physical performance tests to evaluate muscle thickness, subcutaneous fat thickness, abdominal circumference, handgrip strength, and functional performance. These measurements will help identify muscle and fat distribution profiles associated with higher functional risk in older adults.

This study aims to contribute to the understanding of sarcopenic obesity and muscle quality in aging, with the ultimate goal of improving preventive physiotherapy strategies and promoting healthy aging.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 65 years and living in the community.
  • Female sex.
  • Enrolled as a participant in PReGe program.

Exclusion criteria

  • Recent surgery (<6 months) involving the abdomen or lower extremities.
  • Presence of methal prostheses or implants in the thigh or abdoinal region.
  • Diagnosed neuromuscular disease (e.g., myopathies, advanced Parkinson's disease.)
  • Musculoskeletal disorders that impair basic mobility or prevent functional testing.
  • Acute illness or clinical decompensation at the time of assessment.
  • Unintentional weight loss > 5 kg within the past month (suggestive of cachexia risk).
  • Presence of active abdominal hernias or severe diastasis recti.

Treatment and study plan

Primary outcomes

  1. Ultrasound Assessment of the Rectus Femoris Muscle

    Time frame: At a single assessment visit

    The rectus femoris muscle was assessed using B-mode ultrasound imaging, following SARCUS group recommendations. Participants were positioned supine for 5 minutes prior to imaging to ensure fluid redistribution. A linear transducer (12 MHz) was used with neutral probe angle and minimal pressure. The anatomical landmark was the midpoint between the greater trochanter and the upper pole of the patella. Measurements included muscle thickness, pennation angle, fascicle length, echo intensity, cross-sectional area, and subcutaneous fat thickness. Images were taken in both transverse and longitudinal planes. Three measurements were taken per view to ensure accuracy.

  2. Ultrasound Assessment of the Rectus Abdominis Muscle

    Time frame: At a single assessment visit

    The rectus abdominis muscle was assessed using the same ultrasound equipment and imaging protocol as for the rectus femoris. The anatomical reference point was located 3 cm lateral to the umbilicus, as per SARCUS group guidance. Images were acquired in both transverse and longitudinal planes. Measurements included muscle thickness, echo intensity, anatomical cross-sectional area, and subcutaneous fat thickness. Three measurements were taken per view to ensure reliability.

Secondary outcomes

  1. Grip strength test

    Time frame: At a single assessment visit

    Accurate measurement of hand grip strength requires the use of a hand dynamometer (Jamar Plus) calibrated under well-defined (standardized) test conditions. Force values less than 16 Kg are considered positive.

  2. Chair stand test

    Time frame: At a single assessment visit

    It can be used as an indicator of the strength of the lower limb muscles. It measures the amount of time a patient needs to get up five times from a sitting position without using their arms. It will help us to affirm that the person has a probable sarcopenia. Times greater than 15 seconds are considered positive.

  3. Body Mass Index (BMI)

    Time frame: At a single assessment visit

    It is a measure used to assess a person's body weight in relation to their height. It is calculated by dividing a person's weight in kilograms by their height in meters squared (BMI = kg/m²).

  4. Short Physical Performance Battery (SPPB)

    Time frame: At a single assessment visit

    Test to assess physical performance and degree of frailty consisting of 3 subtests: gait speed, balance, and lower limb strength. The maximum score is 12 points and a score ≤ 8 points indicates poor physical performance.

  5. Gait speed

    Time frame: At a single assessment visit

    t is considered a fast, safe and very reliable test for sarcopenia, in a distance of 4 meters, values greater than 0.8 m/s are considered positive

  6. Timed Up and Go (TUG)

    Time frame: At a single assessment visit

    A predictive test for frailty and falls, where individuals are asked to get up from a standard chair, walk to a marker 3 m away, turn around, and sit down again. Times greater than 20 seconds are considered positive.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis Polo Ferrero, PhD

CONTACT

[email protected]

689919744

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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