Physical Therapy Guidelines For Hospitalized Elderly

NCT ID: NCT03297567

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2019-02-28

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.

Detailed Description

Experimental Design: Patients located during the study period and who meet the eligibility criteria will be invited to participate and, after signing the informed consent form, will be evaluated for anthropometric and clinical characteristics. At this moment, 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. Patients from both groups will have an accelerometer placed on the wrist in the dominant limb, which should only be removed at hospital discharge. Besides the level of physical activity, patients will be evaluated for functionality, peripheral muscle strength, length of hospital stay, and incidence of complications during the hospitalization period. The researchers will contact the patients via telephone within 72 hours after hospital discharge in order to apply a questionnaire for identification of the main barriers to stay active during hospitalization.

Conditions

Physical Activity; Hospitalization; Aged; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

verbal guidance and booklet

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.

Group Type: EXPERIMENTAL

verbal guidance and a booklet

Intervention Type: 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

No Intervention

The control group will not receive any type of intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

verbal guidance and a booklet

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Adriana Claudia Lunardi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adriana Lunardi

Role: STUDY_DIRECTOR

Universidade Cidade de Sao Paulo

Locations

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 31521553 (View on PubMed)

Other Identifiers

970669320241192

Identifier Type: -

Identifier Source: org_study_id