NCT07359495

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.

Trial Health

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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Sep 2026

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 15, 2025

Last Update Submit

January 13, 2026

Conditions

Keywords

Healthy agingMuscle QualityPhysical FunctionSarcopenia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (8)

  • Handgrip strength (kg)

    Baseline and 32 weeks

  • Short Physical Performance Battery (SPPB)

    Baseline and 32 weeks

  • Timed Up and Go (TUG)

    Baseline and 32 weeks

  • 5-time sit-to-stand (5STS)

    Baseline and 32 weeks

  • Body Mass Index (BMI)

    Baseline and 32 weeks

  • +3 more secondary outcomes

Other Outcomes (1)

  • Sociodemographic variables

    Baseline and 32 weeks

Study Arms (2)

Intervention Group (Multicomponent training)

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

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.

Intervention Group (Multicomponent training)

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37006, Spain

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Luis Polo Ferrero, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2025

First Posted

January 22, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 15, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations