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NCT Number: NCT07359495

Multicomponent Training and Muscle Quality in Older Women

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Salamanca

Salamanca, 37006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multicomponent training

Other

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.

Primary outcomes

  1. Echo intensity

    Time frame: Baseline and 32 weeks

    Echo intensity (gray scale analysis), using ImageJ software, proposed by the SARCUS consensus and Nutritional Ultrasound ®.

  2. 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.

  3. 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

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Body Fat Percentage

    Time frame: Baseline and 32 weeks

    Total body fat percentage measured through electrical bioimpedance (BIA) using the TANITA BC-418 device (%).

  7. 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.

  8. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis Polo Ferrero, PhD

CONTACT

[email protected]

689919744

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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