Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Old Age; Debility
• Intervention / Treatment: Behavioral: Group-based exercise training during hospitalization

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliana L Teodoro, M.Sc; Phone Number: +55 51 985923129; Email: julopesteodoro@hotmail.com

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital de Clínicas de Porto Alegre
      • Contact: Juliana L Teodoro, MSc; Phone Number: +55 51 985923129; Email: julopesteodoro@hotmail.com
      • Principal Investigator: Emílio H Moriguchi, PhD
      • Sub-Investigator: Eduardo L Cadore, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Behavioral: Group-based exercise training during hospitalization; Multicomponent exercises for 5-7 days with acutely hospitalized older.
No Intervention: Control group; Participants randomized to the control group will receive only the usual hospital care and rehabilitation, without performing multicomponent exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Handgrip strength	Assessed using a handgrip dynamometer	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.	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.	Baseline and after the intervention period (after 7 days)
Walking ability	6 meter walking ability	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	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.	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.	Baseline and after the intervention period (after 7 days)
Mortality	Days alive since admission to hospital	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).	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	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	Baseline and after the intervention period (after 7 days)
Changes in executive function	To assess executive function, the Trail Making Test will be performed	Baseline and after the intervention period (after 7 days)
Level of agitation, sedation and delirium	The Confusion Assessment Method will be used	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.	Baseline and after the intervention period (after 7 days)

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Federal University of Rio Grande do Sul
• Investigators: Principal Investigator: Emílio H Moriguchi, PhD, Hospital de Clínicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2019-0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No