UltrasoundNCT07069777
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 of Ultrasound and Sarcopenia, run by University of Salamanca at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Ultrasound, Sarcopenia, Obesity
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 1 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Older adult
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
Who may be able to join
- Aged ≥ 65 years and living in the community.
- Female sex.
- Enrolled as a participant in PReGe program.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
University of Salamanca
Salamanca, Salamanca, 37007
Roberto Méndez Sánchez, PhD, +34 696503947, ro_mendez@usal.es
About this study
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.
- Conditions
- Ultrasound, Sarcopenia, Obesity
- Keywords
- ultrasound, obesity, sarcopenia, muscle quality, active aging
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At a single assessment visit
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.
Measured: At a single assessment visit
Secondary outcomes (6)
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.
Measured: At a single assessment visit
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.
Measured: At a single assessment visit
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).
Measured: At a single assessment visit
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.
Measured: At a single assessment visit
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
Measured: At a single assessment visit
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.
Measured: At a single assessment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Polo Ferrero, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069777
- Sponsor's protocol ID
- USalamancaOSRFRA
- Status last verified
- May 2025
- First submitted
- 7 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Quality and Subcutaneous Adipose Tissue in the Rectus Femoris and Rectus Abdominis Muscles: Ultrasound Evaluation and Functional Correlation in Older Adults
- ClinicalTrials.gov ID
- NCT07069777
- Acronym / sponsor ID
- USalamancaOSRFRA
- Conditions
- Ultrasound, Sarcopenia, Obesity
- Keywords
- ultrasound, obesity, sarcopenia, muscle quality, active aging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Age groups
- Older adult
- 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
Key inclusion criteria (3 listed)
- Aged ≥ 65 years and living in the community.
- Female sex.
- Enrolled as a participant in PReGe program.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
6 secondary outcomes
Grip strength test
Time frame: At a single assessment visit
Chair stand test
Time frame: At a single assessment visit
Body Mass Index (BMI)
Time frame: At a single assessment visit
Short Physical Performance Battery (SPPB)
Time frame: At a single assessment visit
Gait speed
Time frame: At a single assessment visit
Timed Up and Go (TUG)
Time frame: At a single assessment visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Sarcopenia, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Polo Ferrero, PhD (689919744, pfluis@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Assessment of the Rectus Femoris Muscle (time frame: At a single assessment visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.