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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05317338
Other study ID # 2019-0119
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date December 1, 2023

Study information

Verified date March 2022
Source Hospital de Clinicas de Porto Alegre
Contact Juliana L Teodoro, M.Sc
Phone +55 51 985923129
Email julopesteodoro@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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: 1. Terminal illness; 2. Myocardial infarction in the last 3 months; 3. Unstable cardiovascular disease; 4. Any type of fracture in the last 3 months, which makes it impossible to carry out the movements; 5. Severe dementia.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group-based exercise training during hospitalization
Multicomponent exercises for 5-7 days with acutely hospitalized older.

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (2)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Primary 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 Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Secondary Handgrip strength Assessed using a handgrip dynamometer Baseline and after the intervention period (after 7 days)
Secondary Maximum dynamic muscle strength of lower limbs Maximum strength assessed through the one repetition maximum test in the leg press and knee extension exercises. Baseline and after the intervention period (after 7 days)
Secondary 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. Baseline and after the intervention period (after 7 days)
Secondary Walking ability 6 meter walking ability Baseline and after the intervention period (after 7 days)
Secondary Inflammatory markers The following markers will be collected: C-reactive protein, leptin, tumor necrosis factor, interleukin, interferon, insulin like growth factor, transforming growth factor Baseline and after the intervention period (after 7 days)
Secondary 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. Baseline and after the intervention period (after 7 days)
Secondary 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. Baseline and after the intervention period (after 7 days)
Secondary Mortality Days alive since admission to hospital Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Secondary Clinical condition Information will be collected about clinical conditions (number of days of hospitalization and readmission). Pre and post intervention (after 7 days), 1, 3 and 12 months after hospital discharge.
Secondary Muscle thickness The quadriceps muscle thickness will be evaluated by ultrasonography Baseline and after the intervention period (after 7 days)
Secondary Muscle quality The muscle quality of the quadriceps will be evaluated through echo intensity using an ultrasound device Baseline and after the intervention period (after 7 days)
Secondary Changes in executive function To assess executive function, the Trail Making Test will be performed Baseline and after the intervention period (after 7 days)
Secondary Level of agitation, sedation and delirium The Confusion Assessment Method will be used Baseline and after the intervention period (after 7 days)
Secondary 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. Baseline and after the intervention period (after 7 days)
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