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SarcopeniaNCT07049809

Targeting Sarcopenia and Frailty: Multicomponent Exercise With Focal Muscle Vibration

A study testing Focal Muscle Vibration and Multicomponent Exercise in people with Sarcopenia and Frailty at Older Adults, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to evaluate the efficacy of multicomponent exercises (aerobic exercises, strength exercises, and balance exercises), individualized with the application of a focal muscle vibration machine at the lower extremities, on parameters of sarcopenia (a muscle disease) in health-related physical fitness… Read more about this study

Who is it for?
Ages 75 years and olderHealthy volunteers can take part
What is being tested?
Focal Muscle Vibration and Multicomponent Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSpain
Study dates
2 Jul 2025to 15 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • people over 75 years of age,
  • score ≥18 on the Mini-Mental State Exam (MMSE)
  • score on the Clinical Frailty Scale between 1-6
  • be institutionalized
  • ability to sit unassisted on a chair or in a wheelchair

Who cannot join

  • progressive degenerative diseases
  • uncontrolled symptomatic cardiovascular or respiratory disease
  • current cancer under treatment
  • severe audiovisual impairment

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universitat Internacional de Catalunya

    Barcelona

Other trials in Spain

About this study

Official title: Targeting Sarcopenia and Frailty: Multicomponent Exercise With Focal Muscle Vibration to Reduce Sarcopenia, Frailty Levels, and Cognitive Impairment in Institutionalized Older Adults

This study aimed to evaluate the efficacy of multicomponent exercises (aerobic exercises, strength exercises, and balance exercises), individualized with the application of a focal muscle vibration machine at the lower extremities, on parameters of sarcopenia (a muscle disease) in health-related physical fitness, physical performance, frailty levels, and cognitive function, falls, and hospitalizations in older adults.

Focal muscle vibration is a type of therapeutic technique used with the application of six capsules placed on the lower extremities, three on each bed, each of which generates a tolerable vibration depending on the stimulation of the muscles. It is neither painful nor counterproductive to the muscles in the lower extremities.

Multicomponent exercises refer to the application of exercises through three different modalities: aerobic exercises, strength exercises, and balance exercises. We alternate these three types of exercises to achieve millions of health benefits. The multi-component program will be individualized based on each individual's abilities to avoid risks and achieve maximum benefits.

Read the detailed description

This study presents the hypothesis that it will allow researchers to significantly improve health parameters in very fragile people, which may have positive impacts at both the individual and community levels. The incorporation of focal vibration as part of a multicomponent approach to exercise is innovative and opens new lines of research in the field of rehabilitation and developmental health. Currently, I understand that there is a growing need to address the healthy development and fragility of the large adult population, given the increasing proportion in today's society and the reptes associated with the loss of functional abilities, which studies can allow other scientists to see the benefits of the program in different areas. health parameters after 3 months of intervention.

The participation in the study will include:

  • Authorizing the investigators to access your medical history. This will allow the investigators to collect information about the clinical data of the participants.
  • Authorizing the investigators to share coded clinical information with other research teams. Theparticipant authorize access to information related to hospitalizations and drugs consumed.
  • Allow the collection of data both at the beginning and after the intervention after 3 months by the external research team. Different data will be collected in a single day both at the beginning and at the end of the intervention, with an approximate duration of 35/40 minutes per person. The data that will be collected will give the researchers information about functional status, muscle strength and power and cognitive level. In addition. the levels of sarcopenia in dominant leg will be evaluated with ultrasound. The ultrasound assessment is a painless test through which an attempt will be made to see the amount of muscle and fat present at the level of the dominant lower extremity. In addition, at the beginning and end of the intervention a blood test will be performed by CST personnel. This analysis will be used to evaluate different blood markers of the participants and see how they respond to the different intervention programs.
  • Randomization to one of the 2 study groups: a focal vibration group with multicomponent exercise, an exercise only group.

Prior to the start of the intervention program, and after this 3-month period, a series of functional tests, tests, muscle ultrasound and a blood analysis will be performed. These tests are tests that are normally used in clinics or hospitals as functional or force assessments in the geriatric population. Once the initial evaluation and data analysis has been carried out, a group will subsequently be randomly assigned to one of the 3 groups that is proposed by the study. If still assigned to group 1) combined exercise with focal vibration, repeat for 3 months, 3 days per week and 30 minutes per day, multicomponent exercises (strength, aerobic exercise and balance) combined with focal muscular vibration. In case it continued to be assigned to group 2) multicomponent exercise, repeat for 3 months, 3 days per week and 30 minutes a day, multicomponent exercises (strength, aerobic exercise and balance).

Being tested
Focal Muscle Vibration, Multicomponent Exercise
Keywords
sarcopenia, frailty, older adults, cognition, focal vibration, multicomponent exercise
Medical subject headings
Sarcopenia, Cognitive Dysfunction, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Focal Muscle VibrationCombination product

    The focal vibration machine will be used. The device has 6 muted transducers that generate power between 30-300 Hz, but for this study we will use between 100-150 Hz for 30 minutes.

    The application of the 6 transducers or heads is at the level of the lower extremities, since those muscle groups present the most clinical correlation with functional parameters such as gait and balance. 3 transducers will be placed on one leg (vastus medialis, vastus lateralis and rector anterior) and the other 3 transducers on the other leg, on the same muscles. To speed up the intervention program and cover more participants, 4 focal vibration machines will be used. Each participant wil use 1 machine and 6 transducers, so during the 30 minutes that the intervention lasted, the groups will be of 4 participants with t

  • Multicomponent ExerciseOther

    The program consists of a multi-component approach, integrating aerobics, resistance, and balance training. The weekly schedule include three intervention days: one day focused on aerobic exercise, one day dedicated to resistance training and one day centered on balance training. The combined program is individualized based on the intrinsic capabilities of each individual.

Study groups in NCT07049809
Study groupRoleWhat they receive
Combination Intervention groupExperimental2-month intervention. 3 days/week. 30 minutes/day. Will receive a multicomponent program based on aerobic training, resistance training and balance training, combined with focal muscle vibration. Of the 3 days of weekly intervention, 1 day will be aerobic exercise combined with focal muscle vibration, 1 day resistance exercise with focal muscle vibration and 1 day of balance exercise with focal muscle vibration. The combined program will be individualized based in the intrinsic capabilities of each individual.
Receives: Combination Product: Focal Muscle Vibration; Other: Multicomponent Exercise
Multicomponent Exercise GroupActive comparator3-month intervention. 3 days/week. 30 minutes/day. Will receive a multicomponent program based on aerobic training, resistance training and balance training. The combined program will be individualized based in the intrinsic capabilities of each individual.
Receives: Other: Multicomponent Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short Physical Performance Battery

    Short Physical Performance Battery (SPPB) is a standardized test that evaluates Balance, Gait speed and Lower limb strength (via chair stands). Has a total puntuaction of 12 points: 0-3: Severe physical limitation, 4-6: Moderate limitation, 7-9: Mild limitation, 10-12: Good physical function. The SPPB (Short Physical Performance Battery) is closely related to sarcopenia because it assesses physical function, which is one of the key diagnostic criteria for sarcopenia.

    Measured: From enrollment to the end of treatment at 12 weeks

Secondary outcomes (6)
  1. Demographic and anthropometric assessments

    Age, height, and weight will be provided by the residence physiotherapist with the data they previously had with the clinical histories. BMI will be calculated using the formula BMI = kg/m2. We will use the WHO recommendations for adult population to obtain the categories of "individuals with obesity and without obesity": a) BMI < 30: without obesity and b) BMI ≥ 30: with obesity. The length of time each participant has been institutionalized in the residence will also be taken into account.

    Measured: from enrollment to 12 weeks after treatment

  2. Handgrip

    Handgrip strength will be assessed with the Jamar hand dynamometer (Sammons Preston, Inc., Bolingbrook, IL, USA) in kilograms. Participants will be seated with their elbows flexed at 90° and performing a maximal handgrip strength for three seconds three times with each hand. The mean of the three attempts on each arm will be used in the analysis. This procedure has been shown to have excellent reliability (ICC = 0.85-0.98). Cutoffs are a low handgrip strength of less than 27 kg for men and less than 16 kg for women.

    Measured: from enrollment to 12 weeks after intervention

  3. SARC-F

    SARC-F is a simple, fast screening questionnaire used to identify people at risk of sarcopenia. The SARC-F scale includes 5 components: strength, walking assistance, getting up from a chair, climbing stairs, and falls. Scores range from 0 to 10, with 0 to 2 points for each component. A SARC-F score ≥ 4 suggests a high risk of sarcopenia and signals the need for further assessment (e.g., grip strength, SPPB, muscle mass)

    Measured: from enrollment to 12 weeks after intervention.

  4. Clinical Frailty Scale

    The Clinical frailty scale (CFS) evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). Frailty will be assessed using this scale at the beginning before the intervention and after 6 months, at the end of the program. CFS degrees 1-4 denote non-frailty (declining degrees of robustness), whereas degrees ≥5 indicate frailty

    Measured: from enrollment to 12 weeks after intervention

  5. Muscle ultrasound

    Muscle thickness and cross-sectional area of the rectus femoris, quadriceps and vastus lateralis will be assessed before the intervention and after 3 months . VScan pocket-sized ultrasound with dual probe (GE Healthcare, United States) will be used. The linear probe provides a 2.9 cm aperture and works across a frequency range of 3.4 to 8.0 MHz. For rectus femoris imaging, the depth of imaging will be adjusted until the femur is visualized, and the rectus femoris could be seen superior to vastus intermedius. The probe will be placed perpendicular to the long axis of the femoral shaft. For vastus lateralis visualization, the probe will be placed parallel to the long axis of the femoral shaft, and the depth of imaging will be adjusted until the deep aponeurosis of the vastus lateralis, and the vastus intermedius inferior to it, could be visualized. A large amount of water-based gel will be used, and minimal pressure will be placed on the probe to prevent compression of muscle.

    Measured: from enrollment to 12 weeks after intervention.

  6. Mini Mental State Exam

    The MMSE evaluates several cognitive domains, including orientation, registration, attention and calculation, short-term memory (recall), language, and visuospatial abilities. During the assessment, individuals are asked to perform tasks such as identifying the current date and location, repeating and later recalling a set of words, performing basic arithmetic (e.g., serial sevens), naming objects, following written and verbal commands, writing a sentence, and copying a geometric figure.

    The total MMSE score ranges from 0 to 30 points. Higher scores indicate better cognitive function.

    Measured: from enrollment to 12 weeks after intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start2 Jul 2025
  3. Primary completion26 Sep 2025
  4. Study completion15 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07049809
Sponsor's protocol ID
01-24-175-116
Status last verified
Jul 2025
First submitted
25 Jun 2025
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cordes T, Bischoff LL, Schoene D, Schott N, Voelcker-Rehage C, Meixner C, Appelles LM, Bebenek M, Berwinkel A, Hildebrand C, Jollenbeck T, Johnen B, Kemmler W, Klotzbier T, Korbus H, Rudisch J, Vogt L, Weigelt M, Wittelsberger R, Zwingmann K, Wollesen B. A multicomponent exercise intervention to improve physical functioning, cognition and psychosocial well-being in elderly nursing home residents: a study protocol of a randomized controlled trial in the PROCARE (prevention and occupational health in long-term care) project. BMC Geriatr. 2019 Dec 23;19(1):369. doi: 10.1186/s12877-019-1386-6.

    PubMed 31870314
  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

    PubMed 30312372

Questions about this trial

What is this clinical trial studying?

A study testing Focal Muscle Vibration and Multicomponent Exercise in people with Sarcopenia and Frailty at Older Adults, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Physical Performance Battery (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07049809, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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