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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.
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Intervention group | Experimental | 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. |
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| Multicomponent Exercise Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal Muscle Vibration | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31870314 | Background | 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. | |
| 30312372 |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D060825 | Cognitive Dysfunction |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Multicomponent Exercise | 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. |
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| from enrollment to 12 weeks after treatment |
| 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. | from enrollment to 12 weeks after intervention |
| 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) | from enrollment to 12 weeks after intervention. |
| 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 | from enrollment to 12 weeks after intervention |
| 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. | from enrollment to 12 weeks after intervention. |
| 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. | from enrollment to 12 weeks after intervention. |
| Background |
| 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. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |