Physical Therapy Guidelines For Hospitalized Elderly

Physical Activity Clinical Trial

Official title:

Control Group, Randomized, Blind Assessment of Physical Therapy Guidelines For Hospitalized Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297567
• Other study ID #: 970669320241192
• Status: Completed
• Phase: N/A
• Start date: September 30, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: October 2019
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 28, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Exercise
• Hospitalization
• Physical Activity

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Brazil	Instituto de Assistência Médica ao Servidor Público Estadual	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functionality	The evaluation of functionality will be done by applying the Morton Mobility Index (DEMMI). The DEMMI is a validated scale for elderly individuals during hospitalization and evaluates 15 activities divided into 5 groups: activities in bed, in the chair, static balance, ambulation and dynamic balance. The examiner's evaluation consists in punctuating the performance of the elderly in each of the motor conditions with scores varying from 0.1 to 2 points, resulting in a maximum score of 19 points. A conversion table allows the transformation of the raw score into a specific scale score, called DEMMI scores, ranging from 0 to 100 points, with higher scores indicating a higher level of mobility. The DEMMI scale consists of a paper sheet to be filled with a ballpoint pen, with printed articles on one side and the instruction protocol on the other, which makes it easy to use in clinical practice.	All patients will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Peripheral Muscular Strength	This will be evaluated after inclusion of the patient in the study and at the time of hospital discharge by a handgrip dynamometer (Smedley, Sahean, Belgium). The examiner will position the patient sitting and reclining comfortably in a chair with his feet flat on the floor. The dominant upper limb of the patient should maintain a 90-degree flexion without support and forearm in a neutral position. The unexamined upper limb will be resting, with the hand resting on the thigh. The patient will be asked to perform the manual grip movement. This movement will be repeated three times, with one-minute rest between attempts. The average of the three attempts will be adopted, which will be analyzed in its absolute value and in the reference value previously described for the Brazilian population.	All patients will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Length of hospital stay	It will be counted from admission to the ward until discharge	All patients will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Incidence of complications	These will be checked until the day of discharge through the records of a doctor who will be blind to the group to which the patient belongs. Clinical complications, specifically the appearance of a new health condition during hospitalization will be reported.	All patients will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Barriers to stay active during hospitalization	These will be evaluated within 72 hours after hospital discharge. A questionnaire developed by the researchers themselves and evaluated by specialists (physical therapists who work in the hospital area with more than five years of experience) will be applied via telephone contact. The questionnaire is composed of 16 dichotomous questions with "yes" or "no" answers. The questions concern the presented symptoms and the patient, the knowledge about the importance of the physical activity and the hospital. After the creation of the questionnaire, this was subjected to an evaluation of pertinence and understanding of the questions by 30 physical therapists who work in the hospital area and have at least 5 years of experience. All suggested modifications were accepted and the questionnaire will be applied to the patients.	72 hours after hospital discharge
Secondary	Number of Physiotherapy sessions	The number of physiotherapy sessions received by the patient during the hospitalization period will be counted through the physiotherapeutic evolutions.	All patients will be followed for the duration of hospital stay, an expected average of 7 days