Old Age; DebilityNCT05317338
Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly
A study testing Group-based exercise training during hospitalization in people with Old Age; Debility, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Older patients spend most of their time in situations of muscle disuse during acute hospitalization. Physical inactivity is a key factor for the development of adverse events caused by hospitalization, known as iatrogenic nosocomial disability. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Old Age; Debility
- What is being tested?
- Group-based exercise training during hospitalization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2022to 1 Dec 2023
- 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
- Age 70 years and older;
- Able to tolerate exercise;
- Barthel Index ≥60;
- Be able to walk alone or with the aid of a cane, crutch or walkers;
- Be able to communicate and inform consent to participate in the research.
Who cannot join
- Length of stay <5 days;
- Inability to participate in the testing procedures and/or the multi-component training program, as determined by the physician;
- Present one or more factors:
- Terminal illness;
- Myocardial infarction in the last 3 months;
- Unstable cardiovascular disease;
- Any type of fracture in the last 3 months, which makes it impossible to carry out the movements;
- Severe dementia.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Juliana L Teodoro, MSc, +55 51 985923129, julopesteodoro@hotmail.com
Emílio H Moriguchi, PhD
About this study
Official title: Effects of a Multicomponent Exercise Program on the Functional Performance and Cognitive Ability of Hospitalized Older People: A Randomized Clinical Trial
Older patients spend most of their time in situations of muscle disuse during acute hospitalization. Physical inactivity is a key factor for the development of adverse events caused by hospitalization, known as iatrogenic nosocomial disability. Adopting a multicomponent training program during acute hospitalization can be an efficient strategy to reduce adverse effects and promote improvements in older health. This study is a randomized clinical trial with acutely hospitalized older individuals. Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. The control group will receive only the usual care and rehabilitation.
Read the detailed description
This study is a randomized controlled trial with acutely hospitalized older individuals. The first aim is to evaluate the effects of a multicomponent training intervention on functionality, cognitive ability and inflammatory profile in older patients during acute hospitalization.
The population studied will be older patients (≥ 70 years), admitted to the Internal Medicine sector of the Hospital de Clinicas de Porto Alegre. The number of older people obtained through sample calculation is 30 individuals per group, totaling 60 participants in the study.
Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. Exercises aimed at the lower and upper limbs will be performed, such as sitting and standing up from a chair, leg press, bilateral knee extension and bench press with elastic tape. Balance and gait exercises will also be performed. The training session will be considered complete if patients are able to perform 90% or more of the scheduled exercises, the frequency and possible adverse events will be documented in daily records. The control group will not receive multicomponent physical training, only the usual care provided by the hospital. Both groups will be evaluated before and after 5-7 days of intervention.
- Conditions
- Old Age; Debility
- Being tested
- Group-based exercise training during hospitalization
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based exercise training during hospitalizationBehavioural
Multicomponent exercises for 5-7 days with acutely hospitalized older.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants randomized to this group will be enrolled to a multicomponent training for 5-7 consecutive days and will continue to receive usual hospital care. The training program consists of strength, balance and gait exercises performed within the hospital. Receives: Behavioral: Group-based exercise training during hospitalization |
| Control group | No intervention | Participants randomized to the control group will receive only the usual hospital care and rehabilitation, without performing multicomponent exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional independence scores
By using the Barthel Index. This tool indicates an individual's ability to perform basic activities of daily living. Scores range from 0 (severe functional dependence) to 100 (functional independence).
Measured: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Changes in lower limbs functional capacity
By using the Short Physical Performance Battery (SPPB) the mobility of the lower limbs will be evaluated through static balance tests while standing, walking speed and muscle strength
Measured: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Secondary outcomes (14)
Handgrip strength
Assessed using a handgrip dynamometer
Measured: Baseline and after the intervention period (after 7 days)
Maximum dynamic muscle strength of lower limbs
Maximum strength assessed through the one repetition maximum test in the leg press and knee extension exercises.
Measured: Baseline and after the intervention period (after 7 days)
Lower limb muscle power
Muscle power will be assessed in leg press and knee extension exercises, with intensities of 30% and 60% using an encoder device.
Measured: Baseline and after the intervention period (after 7 days)
Walking ability
6 meter walking ability
Measured: Baseline and after the intervention period (after 7 days)
Inflammatory markers
The following markers will be collected: C-reactive protein, leptin, tumor necrosis factor, interleukin, interferon, insulin like growth factor, transforming growth factor
Measured: Baseline and after the intervention period (after 7 days)
Changes in cognitive state
The Mini Mental State Assessment instrument will be used. Questionnaire with a scale of 0 to 30 points, with 0 being the worst and 30 the best.
Measured: Baseline and after the intervention period (after 7 days)
Changes in quality of life scores
Quality of life will be assessed using the EuroQol-5 Dimension questionnaire. Questionnaire that encompasses 5 health domains (mobility, personal care, usual activities, pain/discomfort and anxiety/depression) whose variation from 0 to 100 corresponds, respectively, to the worst and best health status.
Measured: Baseline and after the intervention period (after 7 days)
Mortality
Days alive since admission to hospital
Measured: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Clinical condition
Information will be collected about clinical conditions (number of days of hospitalization and readmission).
Measured: Pre and post intervention (after 7 days), 1, 3 and 12 months after hospital discharge.
Muscle thickness
The quadriceps muscle thickness will be evaluated by ultrasonography
Measured: Baseline and after the intervention period (after 7 days)
Muscle quality
The muscle quality of the quadriceps will be evaluated through echo intensity using an ultrasound device
Measured: Baseline and after the intervention period (after 7 days)
Changes in executive function
To assess executive function, the Trail Making Test will be performed
Measured: Baseline and after the intervention period (after 7 days)
Level of agitation, sedation and delirium
The Confusion Assessment Method will be used
Measured: Baseline and after the intervention period (after 7 days)
Changes in the depressive symptoms scale
The Geriatric Depression Symptoms (GDS) tool will be used. Score from 0 to 15, if greater than 5, the patient is suspected of having depression.
Measured: Baseline and after the intervention period (after 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Emílio H Moriguchi, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317338
- Sponsor's protocol ID
- 2019-0119
- Status last verified
- Mar 2022
- First submitted
- 8 Dec 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multicomponent Exercise Program on the Functional Performance and Cognitive Ability of Hospitalized Older People: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05317338
- Acronym / sponsor ID
- 2019-0119
- Conditions
- Old Age; Debility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 Apr 2022 (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.
Older patients spend most of their time in situations of muscle disuse during acute hospitalization. Physical inactivity is a key factor for the development of adverse events caused by hospitalization, known as iatrogenic nosocomial disability. Adopting a multicomponent training program during acute hospitalization can be an efficient strategy to reduce adverse effects and promote improvements in older health. This study is a randomized clinical trial with acutely hospitalized older individuals. Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. The control group will receive only the usual care and rehabilitation.
Detailed description
This study is a randomized controlled trial with acutely hospitalized older individuals. The first aim is to evaluate the effects of a multicomponent training intervention on functionality, cognitive ability and inflammatory profile in older patients during acute hospitalization.
The population studied will be older patients (≥ 70 years), admitted to the Internal Medicine sector of the Hospital de Clinicas de Porto Alegre. The number of older people obtained through sample calculation is 30 individuals per group, totaling 60 participants in the study.
Patients will be randomized into intervention and control groups. The intervention group will perform multicomponent training for 5-7 consecutive days, and will continue to receive usual hospital care. Exercises aimed at the lower and upper limbs will be performed, such as sitting and standing up from a chair, leg press, bilateral knee extension and bench press with elastic tape. Balance and gait exercises will also be performed. The training session will be considered complete if patients are able to perform 90% or more of the scheduled exercises, the frequency and possible adverse events will be documented in daily records. The control group will not receive multicomponent physical training, only the usual care provided by the hospital. Both groups will be evaluated before and after 5-7 days of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Group-based exercise training during hospitalizationParticipants randomized to this group will be enrolled to a multicomponent training for 5-7 consecutive days and will continue to receive usual hospital care. The training program consists of strength, balance and gait exercises performed within the hospital. |
| Control group | No intervention | –Participants randomized to the control group will receive only the usual hospital care and rehabilitation, without performing multicomponent exercises. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 70 years and older;
- Able to tolerate exercise;
- Barthel Index ≥60;
- Be able to walk alone or with the aid of a cane, crutch or walkers;
- Be able to communicate and inform consent to participate in the research.
Key exclusion criteria (8 listed)
- Length of stay <5 days;
- Inability to participate in the testing procedures and/or the multi-component training program, as determined by the physician;
- Present one or more factors:
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 |
|---|---|---|
| Group-based exercise training during hospitalizationMulticomponent exercises for 5-7 days with acutely hospitalized older. | Behavioural | Intervention group |
Primary outcome
Changes in functional independence scores
Time frame: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
By using the Barthel Index. This tool indicates an individual's ability to perform basic activities of daily living. Scores range from 0 (severe functional dependence) to 100 (functional independence).
Changes in lower limbs functional capacity
Time frame: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
By using the Short Physical Performance Battery (SPPB) the mobility of the lower limbs will be evaluated through static balance tests while standing, walking speed and muscle strength
14 secondary outcomes
Handgrip strength
Time frame: Baseline and after the intervention period (after 7 days)
Maximum dynamic muscle strength of lower limbs
Time frame: Baseline and after the intervention period (after 7 days)
Lower limb muscle power
Time frame: Baseline and after the intervention period (after 7 days)
Walking ability
Time frame: Baseline and after the intervention period (after 7 days)
Inflammatory markers
Time frame: Baseline and after the intervention period (after 7 days)
Changes in cognitive state
Time frame: Baseline and after the intervention period (after 7 days)
Changes in quality of life scores
Time frame: Baseline and after the intervention period (after 7 days)
Mortality
Time frame: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Clinical condition
Time frame: Pre and post intervention (after 7 days), 1, 3 and 12 months after hospital discharge.
Muscle thickness
Time frame: Baseline and after the intervention period (after 7 days)
Muscle quality
Time frame: Baseline and after the intervention period (after 7 days)
Changes in executive function
Time frame: Baseline and after the intervention period (after 7 days)
Level of agitation, sedation and delirium
Time frame: Baseline and after the intervention period (after 7 days)
Changes in the depressive symptoms scale
Time frame: Baseline and after the intervention period (after 7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Emílio H Moriguchi, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based exercise training during hospitalization in people with Old Age; Debility, run by Hospital de Clinicas de Porto Alegre 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana L Teodoro, M.Sc (+55 51 985923129, julopesteodoro@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in functional independence scores (time frame: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2022.