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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07359495
Enrollment
40
Registered
2026-01-22
Start date
2026-09-01
Completion date
2027-06-15
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

Healthy aging, Muscle Quality, Physical Function, Sarcopenia

Brief summary

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.

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.

Interventions

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.

Sponsors

University of Salamanca
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Echo intensityBaseline and 32 weeksEcho intensity (gray scale analysis), using ImageJ software, proposed by the SARCUS consensus and Nutritional Ultrasound ®.
Muscle thickness (mm)Baseline and 32 weeksLinear measurement of the distance between the superficial and deep aponeuroses of a target muscle belly.
Cross-sectional areaBaseline and 32 weeksThe total area of the muscle (measured in cm\^2) in a plane perpendicular to its longitudinal axis
Subcutaneous adipose tissue thicknessBaseline and 32 weeksMeasurement 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

MeasureTime frameDescription
Handgrip strength (kg)Baseline and 32 weeksHandgrip 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.
Short Physical Performance Battery (SPPB)Baseline and 32 weeksThe 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.
Timed Up and Go (TUG)Baseline and 32 weeksThe 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.
5-time sit-to-stand (5STS)Baseline and 32 weeksThe 5-time sit-to-stand (5STS) test will be used, a functional test serves to assess lower limb strength.
Body Mass Index (BMI)Baseline and 32 weeksalculated 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.
Body Fat PercentageBaseline and 32 weeksTotal body fat percentage measured through electrical bioimpedance (BIA) using the TANITA BC-418 device (%).
Abdominal CircumferenceBaseline and 32 weeksMeasured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest using a flexible tape measure.
Waist-to-Hip RatioBaseline and 32 weeks.Calculated by dividing the waist circumference by the hip circumference. Used as an indicator of abdominal fat distribution.

Countries

Spain

Contacts

CONTACTLuis Polo Ferrero, PhD
pfluis@usal.es689919744

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026