Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-06 @ 7:44 PM
Study NCT ID:
NCT03297567
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2017-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physical Therapy Guidelines For Hospitalized Elderly
Sponsor:
Universidade Cidade de Sao Paulo
Organization:
Study Overview
Official Title:
Control Group, Randomized, Blind Assessment of Physical Therapy Guidelines For Hospitalized Elderly
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: