search
Back to results

Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly

Primary Purpose

Old Age; Debility

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Group-based exercise training during hospitalization
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Old Age; Debility

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

Participants randomized to the control group will receive only the usual hospital care and rehabilitation, without performing multicomponent exercises.

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

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

Full Information

First Posted
December 8, 2021
Last Updated
March 30, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
search

1. Study Identification

Unique Protocol Identification Number
NCT05317338
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Debility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants randomized to the control group will receive only the usual hospital care and rehabilitation, without performing multicomponent exercises.
Intervention Type
Behavioral
Intervention Name(s)
Group-based exercise training during hospitalization
Intervention Description
Multicomponent exercises for 5-7 days with acutely hospitalized older.
Primary Outcome Measure Information:
Title
Changes in functional independence scores
Description
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).
Time Frame
Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Title
Changes in lower limbs functional capacity
Description
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
Time Frame
Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
Assessed using a handgrip dynamometer
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Maximum dynamic muscle strength of lower limbs
Description
Maximum strength assessed through the one repetition maximum test in the leg press and knee extension exercises.
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Lower limb muscle power
Description
Muscle power will be assessed in leg press and knee extension exercises, with intensities of 30% and 60% using an encoder device.
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Walking ability
Description
6 meter walking ability
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Inflammatory markers
Description
The following markers will be collected: C-reactive protein, leptin, tumor necrosis factor, interleukin, interferon, insulin like growth factor, transforming growth factor
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Changes in cognitive state
Description
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.
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Changes in quality of life scores
Description
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.
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Mortality
Description
Days alive since admission to hospital
Time Frame
Pre and post intervention (after 7 days), 1 and 3 months after hospital discharge.
Title
Clinical condition
Description
Information will be collected about clinical conditions (number of days of hospitalization and readmission).
Time Frame
Pre and post intervention (after 7 days), 1, 3 and 12 months after hospital discharge.
Title
Muscle thickness
Description
The quadriceps muscle thickness will be evaluated by ultrasonography
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Muscle quality
Description
The muscle quality of the quadriceps will be evaluated through echo intensity using an ultrasound device
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Changes in executive function
Description
To assess executive function, the Trail Making Test will be performed
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Level of agitation, sedation and delirium
Description
The Confusion Assessment Method will be used
Time Frame
Baseline and after the intervention period (after 7 days)
Title
Changes in the depressive symptoms scale
Description
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.
Time Frame
Baseline and after the intervention period (after 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana L Teodoro, M.Sc
Phone
+55 51 985923129
Email
julopesteodoro@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emílio H Moriguchi, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana L Teodoro, MSc
Phone
+55 51 985923129
Email
julopesteodoro@hotmail.com
First Name & Middle Initial & Last Name & Degree
Emílio H Moriguchi, PhD
First Name & Middle Initial & Last Name & Degree
Eduardo L Cadore, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly

We'll reach out to this number within 24 hrs