Multicomponent Training on Functional and Cognitive Performance of Hospitalized Older People

NCT06682598 | Enrolling By Invitation DMC

• 1 other identifier: uRioGrandeHCPA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Disability; Dynapenia; Cognitive Decline

Keywords

Hospitalization; Frail Older Adults; Physical Exercise; Functional Capacity

Outcome Measures

Primary Outcomes (11)

• 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.

  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

Secondary Outcomes (7)

• Adherence To Intervention

  Immediately after the intervention

• Affectivity with the intervention

  Immediately after the intervention

• Length of Hospitalization

  Immediately after the intervention

• Hospital Readmission

  At 3, 6, and 12 months after the intervention

• Number of falls

  At 3, 6, and 12 months after the intervention

Study Arms (2)

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.

Other: Multicomponent physical exercise training

Control

NO INTERVENTION

Subjects will receive the usual care of the hospital

Interventions

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.

Multicomponent Training

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Hospital de Clinicas de Porto Alegre: collaborator
• UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS): collaborator

Study Sites (1)

Escola de Educação Física Fisioterapia e Dança - UFRGS

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

Related Publications (4)

• 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.

  PMID: 27499307 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.

  PMID: 26577625 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.

  PMID: 26374430 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.

  PMID: 30419096 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 12, 2024
• Study Start: January 28, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the end of the study, no end date for sharing IPD was set.
• Access Criteria: 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.

Locations

BR (1)