Clinical trial NCT05317338: Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly
Official title: Effects of a Multicomponent Exercise Program on the Functional Performance and Cognitive Ability of Hospitalized Older People: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Old Age; Debility
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2022-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Changes in functional independence scores
timeFrame: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
measure: Changes in lower limbs functional capacity
timeFrame: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Secondary outcomes:
measure: Handgrip strength
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Maximum dynamic muscle strength of lower limbs
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Lower limb muscle power
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Walking ability
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Inflammatory markers
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Changes in cognitive state
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Changes in quality of life scores
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Mortality
timeFrame: Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
measure: Clinical condition
timeFrame: Pre and post intervention (after 7 days), 1, 3 and 12 months after hospital discharge.
measure: Muscle thickness
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Muscle quality
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Changes in executive function
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Level of agitation, sedation and delirium
timeFrame: Baseline and after the intervention period (after 7 days)
measure: Changes in the depressive symptoms scale
timeFrame: Baseline and after the intervention period (after 7 days)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Emílio H Moriguchi, PhD
role: PRINCIPAL_INVESTIGATOR
References: