Physical Therapy Guidelines For Hospitalized Elderly

NCT03297567 | Completed DMC

• 1 other identifier: 970669320241192
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The level of physical activity decreases progressively with age. Elderly subjects who are physically active have lower rates of morbidity and mortality when compared to those inactive. Hospitalization leads to long periods of bed rest and physical inactivity, with consequent muscle atrophy, generalized weakness, and decreased independence and functionality. Therefore, preventing inactivity, loss of muscle strength and the worsening of functional performance during hospitalization may be a way to avoid loss of independence. And while movement has been increasingly promoted as an important part of the recovery of hospitalized patients, many of them still spend much of the time bedridden while in hospital. Objectives: To evaluate the impact of a guiding program on the importance of remaining active during hospitalization in relation to the level of physical activity, functionality and muscular strength of elderly patients and to identify the main barriers that impede them to perform physical activities in the hospital environment. Methods: Randomized and controlled trial which will include elderly patients admitted to the Respiratory Diseases and Medical Clinic wards of the Institute of Medical Assistance to State Public Servants, in São Paulo. The intervention group will receive verbal guidelines and one booklet on the deleterious effects of hospitalization and the importance of staying active during hospitalization. All patients will be evaluated through accelerometry to identify the level of physical activity during hospitalization. Functionality will be evaluated through the DEMMI scale, muscular strength through handgrip and the main barriers to stay active during hospitalization by applying a questionnaire. The days of hospitalization and the clinical complications presented by the patients during the stay in the hospital will be noted. The difference of the outcomes of the level of physical activity and functionality before and after the intervention will be compared between the control and the intervention group through a t-test. The length of hospital stay will be analyzed by the Kaplan-Meier test and the incidence of complications by the chi-square test.

Conditions

Physical Activity; Hospitalization; Aged; Exercise

Keywords

Elderly; Hospitalization; Immobilization; Exercise; Accelerometry

Outcome Measures

Primary Outcomes (1)

• Level of physical activity

  This variable will be evaluated by means of accelerometry using the an ActiGraph accelerometer (Actigraph Inc, USA) placed on the wrist of the patient's dominant limb in the first 48 h of admission. The calibration will be performed 24 hours a day, during the entire period of hospitalization, and will be removed only at the moment of hospital discharge. The equipment is waterproof, so there is no need to remove it for bath or personal hygiene, and its battery lasts up to 20 days of consecutive collection. The Actigraph GT3X records the number of steps, the time in different body positions, the intensity of movements and predicts the metabolic rate

  All patients will be followed for the duration of hospital stay, an expected average of 7 days

Secondary Outcomes (6)

• Functionality

  All patients will be followed for the duration of hospital stay, an expected average of 7 days

• Peripheral Muscular Strength

  All patients will be followed for the duration of hospital stay, an expected average of 7 days

• Length of hospital stay

  All patients will be followed for the duration of hospital stay, an expected average of 7 days

• Incidence of complications

  All patients will be followed for the duration of hospital stay, an expected average of 7 days

• Barriers to stay active during hospitalization

  72 hours after hospital discharge

Study Arms (2)

verbal guidance and booklet

EXPERIMENTAL

verbal guidance and a booklet on the importance and benefits of movement during hospital stay, as well as what the patients should do to increase the level of physical activity.

Behavioral: verbal guidance and a booklet

No Intervention

NO INTERVENTION

The control group will not receive any type of intervention

Interventions

verbal guidance and a booklet BEHAVIORAL

Patients allocated to the intervention group will receive verbal instruction from the researchers on the importance and benefits of movement during hospital stay, as well as what they should do to increase the level of physical activity. These patients will receive the same guidelines through a playable, easy-to-understand and inexpensive booklet developed by the researchers themselves in PowerPoint 2016 (Microsoft) in order to remedy any doubt or forgetfulness during the hospitalization period

verbal guidance and booklet

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted in the last 48 hours to the Respiratory Diseases and Medical Clinic wards
• Patients should not present restrictions to leave the bed
• Patients should not present need for professional help or accompanying person for locomotion
• Patients should not present local restriction for the placement of accelerometers (skin infections, amputation or fracture in the dominant limb)
• Patients should not present contact or respiratory isolation
• Patients should not present difficulty in understanding the guidelines or evaluations

You may not qualify if:

• Patients requiring hospital transfer
• Patients in need of surgical intervention
• Patients who not use the accelerometer during the proposed evaluation period

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, 04039-901, Brazil

Location

Related Publications (1)

• Moreno NA, de Aquino BG, Garcia IF, Tavares LS, Costa LF, Giacomassi IWS, Lunardi AC. Physiotherapist advice to older inpatients about the importance of staying physically active during hospitalisation reduces sedentary time, increases daily steps and preserves mobility: a randomised trial. J Physiother. 2019 Oct;65(4):208-214. doi: 10.1016/j.jphys.2019.08.006. Epub 2019 Sep 11.

  PMID: 31521553 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Adriana Lunardi

  Universidade Cidade de Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigations of the level of physical activity, functional outcome, peripheral muscle strength and clinical complications will be performed by a blind investigator. Data analysis will be performed by a blind investigator in the control and intervention groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The patients will be randomized into two groups: intervention and control. The intervention group will receive verbal guidance and a booklet developed by the authors on the deleterious effects of hospitalization and the importance of staying active during hospital admission on the day they are included in the study. The control group will not receive any type of intervention, nor even verbal guidance.

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 29, 2017
• Study Start: September 30, 2017
• Primary Completion: September 30, 2018
• Study Completion: February 28, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)