Multicomponent Training and Muscle Quality in Older Women

January 13, 2026 updated by: Luis Polo Ferrero, University of Salamanca

Effect of a Multicomponent Exercise Program on Muscle Quality Assessed by Ultrasound, Body Composition, and Functionality in Older Women: A Randomized Controlled Trial Protocol

This study aims to evlauate the effect os a 32-week multicomponent training (MT) program on muscle architecture and muscle quality (assessed by ultrasound) in womer over 60 years. The study will also analyze concurrent changes in muscle strength, physical performance, and body composition. The hypothesis is that the training will induce positive architectural adaptations, such as reduced echogenicity and increased thickness in the rectus femoris and rectus abdominis muscles, correlating with improved functional independence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Population aging emphasizes the need for "healthy aging", where muscle quality (MQ) is a vital metric. However, there is a lack of robust longitudinal protocols integrating ultrasound-assessed MQ with functional performance in older women. This randomized controlled trial involves community-dwelling women aged 60+ from the Geriatric Revitalization Program in Salamanca. Participants will be randomized (1:1) into an experimental group (multicomponent training) or a control group. The intervention is a 32-week supervised program (3 sessions/week, 50 min/session) combining aerobic, strength, balance, and coordination exercises. Primary outcomes focus on muscle architecture (echo intensity and thickness) in the rectus femoris and rectus abdominis muscles. Secondary outcomes include functional capacity (SPPB, TUG, 5-time sit-to-stand), handgrip strength, and body composition.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Luis Polo Ferrero, PhD
  • Phone Number: 689919744
  • Email: pfluis@usal.es

Study Locations

  • Spain
    • Salamanca
      • Salamanca, Salamanca, Spain, 37006
        • University of Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a woman over 60 years of age, residing in the community, and enrolled in the GPR

Exclusion Criteria:

  • Having neuromuscular diseases, recent abdominal surgery, metal implants incompatible with measurements, unstable cardiovascular diseases, or previous participation in another exercise program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group (Multicomponent training)
Participants in this group will follow the multi-component exercise programme. The load progression will be based on individual perceived exertion. At the beginning of the intervention, participants will be taught how to interpret the modified Borg scale. At the end of each week, each person's perception of exertion will be recorded in relation to the three sessions completed. The aim will be to maintain a constant level of between 5 and 7 on the scale, which corresponds to 'hard' and 'very hard'. If the perceived exertion is greater than 7, it will be reduced, and conversely, if it is less than 5, the intensity will be increased.
Other: Multicomponent training
The exercise battery includes lower body work (squats, deadlifts, front and sagittal plane lunges, hip abduction/extension, and plantar flexion) and upper body work (wall flexion-extensions, shoulder raises, and elbow flexion-extensions). In addition to the strength exercises mentioned above, balance exercises such as walking in tandem, standing on one leg, side steps, and weight transfer will also be performed. Aerobic capacity will be worked on by walking at a moderate intensity, and flexibility will be improved through stretching the main muscle groups.
No Intervention: Control Group
Participants in this group will maintain their usual diet and physical activity, without changing their habits during the intervention period. They will not participate in other physical exercise programs, nor will they engage in frequent and systematic physical exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Echo intensity
Time Frame: Baseline and 32 weeks
Echo intensity (gray scale analysis), using ImageJ software, proposed by the SARCUS consensus and Nutritional Ultrasound ®.
Baseline and 32 weeks
Muscle thickness (mm)
Time Frame: Baseline and 32 weeks
Linear measurement of the distance between the superficial and deep aponeuroses of a target muscle belly.
Baseline and 32 weeks
Cross-sectional area
Time Frame: Baseline and 32 weeks
The total area of the muscle (measured in cm^2) in a plane perpendicular to its longitudinal axis
Baseline and 32 weeks
Subcutaneous adipose tissue thickness
Time Frame: Baseline and 32 weeks
Measurement of the distance between the dermis and the superficial muscle fascia. This variable quantifies the thickness of the fat layer located directly beneath the skin.
Baseline and 32 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Handgrip strength (kg)
Time Frame: Baseline and 32 weeks
Handgrip strength will be assessed using dynamometry due to its association with various outcomes of aging, being a key component in sarcopenia and frailty. Measurements will be taken using the Hydraulic Jamar device with the subject standing and the elbow flexed at 90º.
Baseline and 32 weeks
Short Physical Performance Battery (SPPB)
Time Frame: Baseline and 32 weeks
The Short Physical Performance Battery (SPPB) will be used, a quick and objective three-part physical function test with excellent test-retest reliability, predictive validity, and clinical applicability, mainly used for fall risk stratification.
Baseline and 32 weeks
Timed Up and Go (TUG)
Time Frame: Baseline and 32 weeks
The Timed Up and Go (TUG) test will be used as it is a valid tool for detecting balance deficits, which are associated with an increased risk of falls in older adults.
Baseline and 32 weeks
5-time sit-to-stand (5STS)
Time Frame: Baseline and 32 weeks
The 5-time sit-to-stand (5STS) test will be used, a functional test serves to assess lower limb strength.
Baseline and 32 weeks
Body Mass Index (BMI)
Time Frame: Baseline and 32 weeks
alculated as weight in kilograms divided by the square of height in meters (kg/m²). It is used to assess changes in body mass relative to height.
Baseline and 32 weeks
Body Fat Percentage
Time Frame: Baseline and 32 weeks
Total body fat percentage measured through electrical bioimpedance (BIA) using the TANITA BC-418 device (%).
Baseline and 32 weeks
Abdominal Circumference
Time Frame: Baseline and 32 weeks
Measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest using a flexible tape measure.
Baseline and 32 weeks
Waist-to-Hip Ratio
Time Frame: Baseline and 32 weeks.
Calculated by dividing the waist circumference by the hip circumference. Used as an indicator of abdominal fat distribution.
Baseline and 32 weeks.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sociodemographic variables
Time Frame: Baseline and 32 weeks
Personal data, medical history, presence of comorbidities, use of medications will be collected in a personal interview, and finally, blood pressure will be taken.
Baseline and 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USalamancaMTUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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