Multicomponent Training and Muscle Quality in Older Women

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: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Other: Multicomponent training

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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Echo intensity	Echo intensity (gray scale analysis), using ImageJ software, proposed by the SARCUS consensus and Nutritional Ultrasound ®.	Baseline and 32 weeks
Muscle thickness (mm)	Linear measurement of the distance between the superficial and deep aponeuroses of a target muscle belly.	Baseline and 32 weeks
Cross-sectional area	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	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

Outcome Measure	Measure Description	Time Frame
Handgrip strength (kg)	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)	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)	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)	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)	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	Total body fat percentage measured through electrical bioimpedance (BIA) using the TANITA BC-418 device (%).	Baseline and 32 weeks
Abdominal Circumference	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	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

Outcome Measure	Measure Description	Time Frame
Sociodemographic variables	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

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Physical Function; Sarcopenia; Healthy aging; Muscle Quality
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID 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