Old Age; Debility Clinical Trial
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.
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | Federal University of Rio Grande do Sul |
Brazil,
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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