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| Name | Class |
|---|---|
| Hospital de Clinicas de Porto Alegre | OTHER |
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The goal of this clinical trial is to determine whether a multicomponent physical exercise program improves functional and cognitive capacity in hospitalized older adults compared to the usual hospital care. The main questions it aims to answer are:
Researchers will compare a multicomponent physical exercise program (containing strength, balance, and walking exercises) to the usual care of the hospital to see if the program is better at maintaining or enhancing functional and cognitive outcomes
Participants will:
Aging is a natural and multifactorial process associated with various physiological and behavioral changes. Some of these changes can lead to increased physical inactivity, resulting in declines in functionality and increased vulnerability to diseases. During acute hospitalization, one of the several clinical consequences is excessive bedrest, even when walking is possible. Which leads to functional decline, defined as iatrogenic nosocomial disability. The literature already well describes that a multicomponent physical exercise program improves functional and cognitive capacity in frail, institutionalized, or hospitalized old people. However, a program based on this model has not yet been implemented during short-term hospitalization in Brazil. Therefore, this study aims to evaluate the effects of a multicomponent program on functional performance and cognitive function in elderly individuals with different conditions of frailty during acute hospitalization at the "Hospital de ClÃnicas de Porto Alegre". Functional performance will be assessed using the Short Physical Performance Battery, Timed Up and Go, 6-meter gait velocity, handgrip strength, and muscle power in 3-times-sit-to-stand. Cognitive performance will be evaluated through the Mini-Mental State Examination, Geriatric Depression Scale-15, and part "A" of the Trail Making Test. Affectiveness of the intervention will be measured using the Affectivity Scale. Participants will be randomized into two groups: multicomponent training based on VIVIFRAIL (MT) and control group. Participants in both groups will receive usual hospital treatments, including physiotherapy sessions in the morning. Participants in the MT group will perform the exercise program adjusted to their frailty and with progressive volume in the afternoon. On hospital discharge day, patients will be re-evaluated. Statistical analysis will be conducted using Generalized Estimating Equations, adopting group and time factors with two stratifications. Post-hoc LSD tests will be used to identify differences between groups. Analyses will be performed both per protocol, for individuals who complete the study, and by intention-to-treat, including those who do not complete the protocol. Results will be considered significant when p ≤ 0.05 and presented as percentage change and standard deviation with a 95% confidence interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent Training | Experimental | The subjects will perform multicomponent training sessions every day until hospital discharge day. It is composed of strength, power, balance, and walking exercises. The intervention is based on the VIVIFRAIL program, adapted for the participant's functional level. |
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| Control | No Intervention | Subjects will receive the usual care of the hospital |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicomponent physical exercise training | Other | The subjects will perform one session per day of multicomponent physical exercise training, consisting of strength, power, balance, and walking exercises. The program will have progressive intensity and volume, adapted to the frailty level of the patient. The frailty level will be screened by the Short Physical Performance Battery. Each session will consist of two strength exercises for the upper limbs and one to three for the lower limbs. Also, one exercise for balance, and walking. Participants will be instructed to perform the concentric phase of the movement as fast as possible, since a good quality of movement is maintained, and the eccentric phase in two seconds. An expert researcher will supervise the entire session. |
| Measure | Description | Time Frame |
|---|---|---|
| Short Physical Performance Battery | The Short Physical Performance Battery will assess three components: static balance by having the participant stand for 10 seconds in three different positions (feet together side-by-side, semi-tandem, and tandem); gait by a 4-meter walk; and leg strength by a five-times sit-to-stand test. It ranges from zero (absence of depressive symptoms) to fifteen points (maximum score of depressive symptoms). Performance is quantified by scoring. The score ranges from 0 (functional disability) to 12 points (robust). | Baseline and immediately after the intervention |
| Timed Up and Go | The Timed Up and Go test will assess dynamic balance by having the participant stand up from a chair, walk 3 meters, turn around, and return to the chair. | Baseline and immediately after the intervention |
| 6-meter walk test | Participants will be asked to walk a 6-meter course at their usual pace, and the time taken will be recorded. | Baseline and immediately after the intervention |
| Sit-To-Stand Muscle Power | A linear encoder will assess the muscle power in the sit-to-stand test. The values of the best repetition will be considered. | Baseline and immediately after the intervention |
| Hand Grip Strength | Assessed by Hand Grip Test with Hydraulic Dynamometer | Baseline and immediately after the intervention |
| Gait Symmetry | Gait symmetry will be assessed by an inertial sensor. It will be obtained from the autocorrelation function of the acceleration signal along the x-axis. Gait symmetry will be considered the difference between the prominence of the first peak and the second peak after the central peak. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence To Intervention | This will be collected by the number of sessions performed during hospitalization. | Immediately after the intervention |
| Affectivity with the intervention | Will be assessed by a scale (+5 = very good, -5 = very bad). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escola de Educação FÃsica Fisioterapia e Dança - UFRGS | Porto Alegre | Rio Grande do Sul | 90690-200 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27499307 | Background | Izquierdo M, Rodriguez-Manas L, Sinclair AJ. Editorial: What Is New in Exercise Regimes for Frail Older People - How Does the Erasmus Vivifrail Project Take Us Forward? J Nutr Health Aging. 2016;20(7):736-7. doi: 10.1007/s12603-016-0702-5. No abstract available. | |
| 26577625 | Background | Martinikorena I, Martinez-Ramirez A, Gomez M, Lecumberri P, Casas-Herrero A, Cadore EL, Millor N, Zambom-Ferraresi F, Idoate F, Izquierdo M. Gait Variability Related to Muscle Quality and Muscle Power Output in Frail Nonagenarian Older Adults. J Am Med Dir Assoc. 2016 Feb;17(2):162-7. doi: 10.1016/j.jamda.2015.09.015. Epub 2015 Nov 11. |
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After the end of study, a deidentified data set will be available upon request
After the end of the study, no end date for sharing IPD was set.
Researchers affiliated with recognized research institutions, with a research project approved by an ethics committee for the protection of human subjects, will have access to the following data: the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code. They can request access by emailing the principal investigator with all necessary information. After review, a data table will be sent.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Baseline and immediately after the intervention |
| Gait Regularity | Gait regularity will be assessed by an inertial sensor. It will be measured using the approximate entropy of the acceleration signal. | Baseline and immediately after the intervention |
| Gait Variability | Gait variability will be assessed by an inertial sensor. It will be estimated by calculating the coefficient of variation of the step time. | Baseline and immediately after the intervention |
| Mini Exam of Mental State | It is a screening tool used to assess cognitive function, with scoring based on a 30-point scale, where lower scores indicate greater cognitive impairment. It ranges from zero (cognitive impairment) to thirty points (good cognitive function). | Baseline and immediately after the intervention |
| Trial Making Test Part A | It is an assessment of cognitive functions. In Part A, participants connect numbered circles in sequential order. The time taken to complete the task is recorded, with longer times indicating potential cognitive impairment | Baseline and immediately after the intervention |
| Geriatric Depression Scale | It is a depressive symptoms scale, that consists of 15 questions with binary answers (yes/no) and is easy to understand. It ranges from zero (absence of depressive symptoms) to fifteen points (maximum score of depressive symptoms). | Baseline and immediately after the intervention |
| Immediately after the intervention |
| Length of Hospitalization | It will be collected through medical records | Immediately after the intervention |
| Hospital Readmission | Data will be collected through telephone calls with family members at 3, 6, and 12 months following hospital discharge | At 3, 6, and 12 months after the intervention |
| Number of falls | Data will be collected through telephone calls with family members at 3, 6, and 12 months following hospital discharge | At 3, 6, and 12 months after the intervention |
| Institutionalization post-hospitalization | Data will be collected through telephone calls with family members at 3, 6, and 12 months following hospital discharge | At 3, 6, and 12 months after the intervention |
| Mortality | Data will be collected through telephone calls with family members at 3, 6, and 12 months following hospital discharge | At 3, 6, and 12 months after the intervention |
| 26374430 | Background | Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Suarez N, Alonso-Renedo J, Contin KC, de Asteasu ML, Echeverria NF, Lazaro MG, Izquierdo M. Functional and cognitive impairment prevention through early physical activity for geriatric hospitalized patients: study protocol for a randomized controlled trial. BMC Geriatr. 2015 Sep 15;15:112. doi: 10.1186/s12877-015-0109-x. |
| 30419096 | Background | Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869. |