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
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
January 22, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
Study Completion
Last participant's last visit for all outcomes
June 15, 2027
January 22, 2026
January 1, 2026
9 months
December 15, 2025
January 13, 2026
Conditions
Keywords
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)
EXPERIMENTALParticipants 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.
Control Group
NO INTERVENTIONParticipants 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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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