Clinical trial NCT06682598: Multicomponent Training on Functional and Cognitive Performance of Hospitalized Older People
Official title: Effects of a Multicomponent Training Based on the VIVIFRAIL Program on Functional Performance and Cognitive Function in Acutely Hospitalized Older People
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Functional Disability
Dynapenia
Cognitive Decline
Keywords: Hospitalization
Frail Older Adults
Physical Exercise
Functional Capacity
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
name: UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

* Does a multicomponent physical exercise program improve functional and cognitive capacity?
* Is there a difference between a multicomponent physical exercise program and usual care regarding functional and cognitive outcomes after an acute hospitalization?

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:

* Participate in multicomponent physical exercise program or receive usual care. The multicomponent group will complete the program daily for the entire hospitalization period;
* Perform functional and cognitive tests at the beginning and end of hospitalization;
* Be contacted by researchers 3, 6, and 12 months after hospital discharge.

Detailed description: 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 Clínicas 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.

Eligibility criteria: Inclusion Criteria:

* Aged 70 years or older;
* Capable of ambulating independently or with assistance;
* Pre-hospitalization Barthel Index ≥ 60;
* Does not have a terminal illness;
* Able to participate in the testing procedures and the multicomponent training program, as determined by the physician;
* Capable of providing informed consent for participation in the study.

Exclusion Criteria:

* Duration of hospitalization \< 3 days;
* Lack of willingness to complete the phases of the project;
* Complications related to disease progression or intervention.

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: Baseline and immediately after the intervention
measure: Timed Up and Go
timeFrame: Baseline and immediately after the intervention
measure: 6-meter walk test
timeFrame: Baseline and immediately after the intervention
measure: Sit-To-Stand Muscle Power
timeFrame: Baseline and immediately after the intervention
measure: Hand Grip Strength
timeFrame: Baseline and immediately after the intervention
measure: Gait Symmetry
timeFrame: Baseline and immediately after the intervention
measure: Gait Regularity
timeFrame: Baseline and immediately after the intervention
measure: Gait Variability
timeFrame: Baseline and immediately after the intervention
measure: Mini Exam of Mental State
timeFrame: Baseline and immediately after the intervention
measure: Trial Making Test Part A
timeFrame: Baseline and immediately after the intervention
measure: Geriatric Depression Scale
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Adherence To Intervention
timeFrame: Immediately after the intervention
measure: Affectivity with the intervention
timeFrame: Immediately after the intervention
measure: Length of Hospitalization
timeFrame: Immediately after the intervention
measure: Hospital Readmission
timeFrame: At 3, 6, and 12 months after the intervention
measure: Number of falls
timeFrame: At 3, 6, and 12 months after the intervention
measure: Institutionalization post-hospitalization
timeFrame: At 3, 6, and 12 months after the intervention
measure: Mortality
timeFrame: At 3, 6, and 12 months after the intervention
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Escola de Educação Física Fisioterapia e Dança - UFRGS
state: RS
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.