NCT07069777

Brief 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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 17, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

July 7, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

ultrasoundobesitysarcopeniamuscle qualityactive aging

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At a single assessment visit

Secondary Outcomes (6)

  • Grip strength test

    At a single assessment visit

  • Chair stand test

    At a single assessment visit

  • Body Mass Index (BMI)

    At a single assessment visit

  • Short Physical Performance Battery (SPPB)

    At a single assessment visit

  • Gait speed

    At a single assessment visit

  • +1 more secondary outcomes

Study Arms (4)

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.

Eligibility Criteria

Age65 Years+
Sexfemale
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

SarcopeniaObesity

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Central Study Contacts

Luis Polo Ferrero, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy at the University of Salamanca

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 17, 2025

Study Start

September 1, 2025

Primary Completion

October 15, 2025

Study Completion

November 1, 2025

Last Updated

July 17, 2025

Record last verified: 2025-05

Locations