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Not yet recruitingNCT07069777Updated Jul 17, 2025

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

An observational study in Ultrasound, Sarcopenia and Obesity, sponsored by University of Salamanca. Not yet recruiting at 1 site in Spain. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.

Sponsored by University of Salamanca · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
65 Years and older
Sex
Female
01

Study summary

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?

Read the detailed description

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.

02

Conditions studied

  • Ultrasound
  • Sarcopenia
  • Obesity

Keywords

  • ultrasound
  • obesity
  • sarcopenia
  • muscle quality
  • active aging
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 419 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

University of Salamanca is the lead sponsor of 110 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Community-dwelling women aged 65 years and older participating in the PReGe (research on active aging with preventive physiotherapy) project. The population is generally independent in activities of daily living and not institutionalized

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Obesity with low strenght

    BMI \>30 and/or waist circumference of 88 cm or more and grip strength \<16 kg.

  • Obesity with normal strength

    BMI \>30 and/or waist circumference of 88 cm or more and grip strength \>16 kg.

  • Non-obesity with normal strength.

    BMI \<30 and/or waist circumference less than 88 cm and grip strength \>16 kg.

  • Non-obesity with low strength.

    BMI \<30 and/or waist circumference less than 88 cm and grip strength \<16 kg.

06

What researchers measure

Primary outcomes

  1. Ultrasound Assessment of the Rectus Femoris Muscle

    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.

    Time frame: At a single assessment visit

  2. Ultrasound Assessment of the Rectus Abdominis Muscle

    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.

    Time frame: At a single assessment visit

Secondary outcomes

  1. Grip strength test

    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.

    Time frame: At a single assessment visit

  2. Chair stand test

    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.

    Time frame: At a single assessment visit

  3. Body Mass Index (BMI)

    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).

    Time frame: At a single assessment visit

  4. Short Physical Performance Battery (SPPB)

    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.

    Time frame: At a single assessment visit

  5. Gait speed

    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

    Time frame: At a single assessment visit

  6. Timed Up and Go (TUG)

    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.

    Time frame: At a single assessment visit

07

Study locations

1 site
  • University of Salamanca
    Salamanca, Salamanca 37007, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07069777
Lead sponsor
University of Salamanca
Responsible party
Luis Polo Ferrero (Associate Professor of Physical Therapy at the University of Salamanca, University of Salamanca) — Principal investigator
First posted
Jul 17, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Oct 15, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Jul 17, 2025

Study contacts

Luis Polo Ferrero, PhD
Contact
pfluis@usal.es
689919744
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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