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Clinical Trials/NCT05317338
NCT05317338
Unknown
Not Applicable

Effects of a Multicomponent Exercise Program on the Functional Performance and Cognitive Ability of Hospitalized Older People: A Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre1 site in 1 country60 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Old Age; Debility
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
60
Locations
1
Primary Endpoint
Changes in functional independence scores
Last Updated
4 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
December 1, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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:
  • 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Muscle thickness(Baseline and after the intervention period (after 7 days))
  • Inflammatory markers(Baseline and after the intervention period (after 7 days))
  • Muscle quality(Baseline and after the intervention period (after 7 days))
  • Maximum dynamic muscle strength of lower limbs(Baseline and after the intervention period (after 7 days))
  • Changes in quality of life scores(Baseline and after the intervention period (after 7 days))
  • Mortality(Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.)
  • Clinical condition(Pre and post intervention (after 7 days), 1, 3 and 12 months after hospital discharge.)
  • Walking ability(Baseline and after the intervention period (after 7 days))
  • Changes in the depressive symptoms scale(Baseline and after the intervention period (after 7 days))
  • Handgrip strength(Baseline and after the intervention period (after 7 days))
  • Lower limb muscle power(Baseline and after the intervention period (after 7 days))
  • Changes in cognitive state(Baseline and after the intervention period (after 7 days))
  • Level of agitation, sedation and delirium(Baseline and after the intervention period (after 7 days))
  • Changes in executive function(Baseline and after the intervention period (after 7 days))

Study Sites (1)

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