Multicomponent Exercises in Functional Performance and Cognitive Ability of Hospitalized Elderly

NCT05317338 | Unknown

• 1 other identifier: 2019-0119
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Old Age; Debility

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Handgrip strength

  Baseline and after the intervention period (after 7 days)

• Maximum dynamic muscle strength of lower limbs

  Baseline and after the intervention period (after 7 days)

• Lower limb muscle power

  Baseline and after the intervention period (after 7 days)

• Walking ability

  Baseline and after the intervention period (after 7 days)

• Inflammatory markers

  Baseline and after the intervention period (after 7 days)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Group-based exercise training during hospitalization BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Federal University of Rio Grande do Sul: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emílio H Moriguchi, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana L Teodoro, M.Sc

CONTACT

+55 51 985923129; julopesteodoro@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: April 7, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)