Functional DisabilityNCT06682598

Multicomponent Training on Functional and Cognitive Performance of Hospitalized Older People

A study testing Multicomponent physical exercise training in people with Functional Disability and Dynapenia, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: Functional Disability, Dynapenia, Cognitive Decline
What is being tested?: Multicomponent physical exercise training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteBrazil
Study dates: 28 Jan 2024to 1 Jun 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Escola de Educação Física Fisioterapia e Dança - UFRGS
Porto Alegre, Rio Grande do Sul, 90690-200

Other trials in Brazil

About this study

Official title: Effects of a Multicomponent Training Based on the VIVIFRAIL Program on Functional Performance and Cognitive Function in Acutely Hospitalized Older People

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.

Read the 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.

Conditions: Functional Disability, Dynapenia, Cognitive Decline
Being tested: Multicomponent physical exercise training
Keywords: Hospitalization, Frail Older Adults, Physical Exercise, Functional Capacity
Medical subject headings: Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multicomponent physical exercise trainingOther
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.

Study groups in NCT06682598
Study group	Role	What they receive
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. Receives: Other: Multicomponent physical exercise training
Control	No intervention	Subjects will receive the usual care of the hospital

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and immediately after the intervention
Hand Grip Strength
Assessed by Hand Grip Test with Hydraulic Dynamometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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).
Measured: Baseline and immediately after the intervention

Secondary outcomes (7)

Adherence To Intervention
This will be collected by the number of sessions performed during hospitalization.
Measured: Immediately after the intervention
Affectivity with the intervention
Will be assessed by a scale (+5 = very good, -5 = very bad).
Measured: Immediately after the intervention
Length of Hospitalization
It will be collected through medical records
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 3, 6, and 12 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 20241 Jun 2025

First posted12 Nov 2024
Study start28 Jan 2024
Primary completion1 Jun 2025
Study completion1 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Functional DisabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06682598
Sponsor's protocol ID: uRioGrandeHCPA
Status last verified: Jun 2026
First submitted: 28 Oct 2024
Last updated: 3 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After the end of study, a deidentified data set will be available upon request

Publications

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.
PubMed 27499307
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.
PubMed 26577625
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.
PubMed 26374430
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.
PubMed 30419096
Bandeira-Guimaraes M, Blanco-Rambo E, Izquierdo M, Rubin N, Calandrini AB, Barreto PS, de Mello RGB, Bottaro M, Moriguchi EH, Pietta-Dias C, Saez de Asteasu ML, Cadore EL. Preservation of functional capacity and lower-limb mechanical power during acute hospitalisation: effects of a low-cost multicomponent exercise programme in older adults-a randomised controlled trial. Age Ageing. 2026 Aug 3;55(10):afag301. doi: 10.1093/ageing/afag301.
PubMed 42891965

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Multicomponent Training Based on the VIVIFRAIL Program on Functional Performance and Cognitive Function in Acutely Hospitalized Older People
ClinicalTrials.gov ID: NCT06682598
Acronym / sponsor ID: uRioGrandeHCPA
Conditions: Functional Disability, Dynapenia, Cognitive Decline
Keywords: Hospitalization, Frail Older Adults, Physical Exercise, Functional Capacity
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Federal University of Rio Grande do SulUniversity, hospital or other
Collaborators: Hospital de Clinicas de Porto Alegre
Study start: 28 Jan 2024 (actual)
Primary completion: 1 Jun 2025 (actual)
Study completion: 1 Jun 2025 (actual)
First posted: 12 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Multicomponent Training	Experimental	Other: Multicomponent physical exercise trainingThe 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.
Control	No intervention	–Subjects will receive the usual care of the hospital

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multicomponent physical exercise trainingThe 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.	Other	Multicomponent Training

Primary outcome

Short Physical Performance Battery
Time frame: Baseline and immediately after the intervention
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).
Timed Up and Go
Time frame: Baseline and immediately after the intervention
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.
6-meter walk test
Time frame: Baseline and immediately after the intervention
Participants will be asked to walk a 6-meter course at their usual pace, and the time taken will be recorded.
Sit-To-Stand Muscle Power
Time frame: Baseline and immediately after the intervention
A linear encoder will assess the muscle power in the sit-to-stand test. The values of the best repetition will be considered.
Hand Grip Strength
Time frame: Baseline and immediately after the intervention
Assessed by Hand Grip Test with Hydraulic Dynamometer
Gait Symmetry
Time frame: Baseline and immediately after the intervention
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.
Gait Regularity
Time frame: Baseline and immediately after the intervention
Gait regularity will be assessed by an inertial sensor. It will be measured using the approximate entropy of the acceleration signal.
Gait Variability
Time frame: Baseline and immediately after the intervention
Gait variability will be assessed by an inertial sensor. It will be estimated by calculating the coefficient of variation of the step time.
Mini Exam of Mental State
Time frame: Baseline and immediately after the intervention
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).
Trial Making Test Part A
Time frame: Baseline and immediately after the intervention
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
Geriatric Depression Scale
Time frame: Baseline and immediately after the intervention
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).

7 secondary outcomes

Adherence To Intervention
Time frame: Immediately after the intervention
Affectivity with the intervention
Time frame: Immediately after the intervention
Length of Hospitalization
Time frame: Immediately after the intervention
Hospital Readmission
Time frame: At 3, 6, and 12 months after the intervention
Number of falls
Time frame: At 3, 6, and 12 months after the intervention
Institutionalization post-hospitalization
Time frame: At 3, 6, and 12 months after the intervention
Mortality
Time frame: At 3, 6, and 12 months after the intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
Background: PubMed 27499307Izquierdo 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.
Background: PubMed 26577625Martinikorena 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.
Background: PubMed 26374430Martinez-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.
Background: PubMed 30419096Martinez-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.
Derived from this study: PubMed 42891965Bandeira-Guimaraes M, Blanco-Rambo E, Izquierdo M, Rubin N, Calandrini AB, Barreto PS, de Mello RGB, Bottaro M, Moriguchi EH, Pietta-Dias C, Saez de Asteasu ML, Cadore EL. Preservation of functional capacity and lower-limb mechanical power during acute hospitalisation: effects of a low-cost multicomponent exercise programme in older adults-a randomised controlled trial. Age Ageing. 2026 Aug 3;55(10):afag301. doi: 10.1093/ageing/afag301.
Individual participant dataSharing planned: Yes. After the end of study, a deidentified data set will be available upon request

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent physical exercise training in people with Functional Disability and Dynapenia, run by Federal University of Rio Grande do Sul at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Physical Performance Battery (time frame: Baseline and immediately after the intervention). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06682598, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.