Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly

NCT ID: NCT05317338

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-12-01

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.

Conditions

Old Age; Debility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Group-based exercise training during hospitalization

Intervention Type: BEHAVIORAL

Multicomponent exercises for 5-7 days with acutely hospitalized older.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group-based exercise training during hospitalization

Multicomponent exercises for 5-7 days with acutely hospitalized older.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Rio Grande do Sul

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emílio H Moriguchi, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Central Contacts

Juliana L Teodoro, M.Sc

Role: CONTACT

julopesteodoro@hotmail.com

+55 51 985923129

Facility Contacts

Juliana L Teodoro, MSc

Role: primary

julopesteodoro@hotmail.com

+55 51 985923129

Other Identifiers

2019-0119

Identifier Type: -

Identifier Source: org_study_id