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临床试验/NCT03297567
NCT03297567已完成不适用

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

Universidade Cidade de Sao Paulo2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2017年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Level of physical activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: verbal guidance and a booklet (Behavioral)

No Intervention

No Intervention

The control group will not receive any type of intervention

结局指标

主要结局

Level of physical activity

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

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

次要结局

  • Incidence of complications(All patients will be followed for the duration of hospital stay, an expected average of 7 days)
  • Functionality(All patients will be followed for the duration of hospital stay, an expected average of 7 days)
  • Number of Physiotherapy sessions(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)
  • Barriers to stay active during hospitalization(72 hours after hospital discharge)

研究者

发起方
Universidade Cidade de Sao Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriana Claudia Lunardi

Principal Investigator

Universidade Cidade de Sao Paulo

研究点 (2)

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