Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05317338
• Other study ID #: 2019-0119
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Juliana L Teodoro, M.Sc
• Phone: +55 51 985923129
• Email: julopesteodoro[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Frailty
• Old Age; Debility

Intervention

Behavioral:
• Group-based exercise training during hospitalization
Multicomponent exercises for 5-7 days with acutely hospitalized older.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

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)