Targeting Sarcopenia and Frailty: Multicomponent Exercise With Focal Muscle Vibration

NCT ID: NCT07049809

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-02
• Study Completion Date: 2025-10-31

Brief 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, 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.

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).

Conditions

Sarcopenia; Frailty at Older Adults; Cognitive Impairment; Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Combination Intervention group

2-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.

Group Type: EXPERIMENTAL

Focal Muscle Vibration

Intervention Type: COMBINATION_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 Exercise

Intervention Type: OTHER

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.

Multicomponent Exercise Group

3-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.

Group Type: ACTIVE_COMPARATOR

Multicomponent Exercise

Intervention Type: OTHER

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.

Interventions

Focal Muscle Vibration

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

Intervention Type: COMBINATION_PRODUCT

Multicomponent Exercise

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Sergi Rodriguez Rodriguez

Physiotherapist. Professor at the department of Medicine.

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 31870314 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30312372 (View on PubMed)

Other Identifiers

01-24-175-116

Identifier Type: -

Identifier Source: org_study_id