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Early Mobilization clinical trials

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NCT ID: NCT06405529 Not yet recruiting - Rehabilitation Clinical Trials

Rehabilitation of Patients From the ICU to the Post-hospital Phase

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Introduction: Advances in knowledge have contributed to the increase in the number of patients who survive prolonged hospitalization in an Intensive Care Unit (ICU), and, among them, critically ill patients who develop acute respiratory failure and need for mechanical ventilation. These individuals have their mobility restricted to bed, and may suffer from pulmonary and systemic complications, such as ICU-Acquired Muscle Weakness, which increases the chances of resulting in reduced functional capacity or death. Early mobilization in the ICU has demonstrated benefits, but still with a low level of evidence. However, the type and intensity of exercise still need to be better defined, and previous protocols did not offer continuous monitoring from the ICU to the ward and subsequent outpatient rehabilitation for these patients, which is considered a limitation in some studies. Objective: To investigate the effects of an early and intensive hospital mobilization and post-hospital rehabilitation program on indicators of functionality, inflammation, cost-effectiveness, and mortality in critically ill patients undergoing invasive mechanical ventilation. Methods: This is a Blind Randomized Controlled Clinical Trial that will be conducted in the ICUs of the Hospital das Clinicas and the Emergency Unit of the Faculty of Medicine of Ribeirao Preto of the University of São Paulo. Patients of both sexes over 21 years of age who have been under invasive mechanical ventilation for at least 24 hours will be recruited. Patients will be randomized into the Intervention Group (IG), with 30 to 60 minutes of exercise per day, and the Control Group (CG), with 10 minutes of exercise per day, both with the same protocol and based on the ICU Mobility Scale - IMS, with continuity in the ward. After hospital discharge, participants will be allocated to the Guidance Group (GIor and GCor) and the Outpatient Rehabilitation Group (GIreab and GCreab), with functional exercise capacity as the main outcome, assessed by the six-minute walk test (6MWT). Volunteers will be monitored one, three, and six months after hospital discharge. The sample calculation was based on the results of the 6MWT , with a power of 80% for the assessments carried out at the proposing institution (n=206), and with a power of 90% for the multicenter project (n=275), considering a sample loss of 30%. The following will be evaluated: clinical parameters, severity indexes, functionality, lung function and mechanics, functional exercise capacity, mortality, inflammatory markers, energy expenditure, activities of daily living, quality of life, muscle assessment, adherence, barriers and facilitators and cost-effectiveness.

NCT ID: NCT06389240 Active, not recruiting - Early Mobilization Clinical Trials

Early Weight Bearing in Unicondylar Tibial Plateau Fractures

Start date: December 21, 2022
Phase:
Study type: Observational

The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care). It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome

NCT ID: NCT06344468 Completed - Critical Care Clinical Trials

The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

The goal of this is randomized controlled study to examine the effect of early mobilization on sleep, physiological parameters, and length of stay in the intensive care unit (ICU). The hypothesis are: Hypothesis I: Early mobilization positively affects the sleep quality of patients. Hypothesis II: Early mobilization positively affects the physiological parameters of patients (respiratory rate, heart rate, blood pressure, body temperature, pain). Hypothesis III: Early mobilization shortens the length of stay of patients in the intensive care unit (ICU). Early mobilization will begin in the experimental group after sedation is discontinued within the first 12 hours and its effects disappear. In early mobilization, in the evaluation of in-bed mobilization, physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Surgical wounds and dressing areas, if any, are protected, drains are identified, care is taken not to remove equipment such as urinary catheters or nasogastric tubes, when the patient is seated on the edge of the bed with the help of a nurse, when he/she is stood up next to the bed with the support of the nurse, when he/she is made to sit in a chair next to the bed and when he/she is in a chair. While sitting, 1st minute, 5th minute, 10th minute respiratory rate, sPO2, heart rate, blood pressure, body temperature values and pain levels will be recorded and these data will be evaluated on their own. During mobilization, if the patient develops chest pain, arrhythmia, hypertension (systolic pressure>160 mmHg), or hypotension (systolic pressure<90 mmHg), tachypnea, or hypoxia, a break will be taken and the physician will be consulted. The same procedures will be repeated during the mobilization of the patient in the first 24-36 hours and the necessary records will be made by the researcher. Control Group: After admission to the Cardiovascular Surgery ICU, the type, purpose and implementation process of the study will be explained to the patients, and a routine/standard postoperative mobilization procedure will be applied to the patients in the control group. Accordingly, patients will be mobilized in the first 24 hours after surgery, and in the evaluation of in-bed mobilization, their physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Again, arterial blood gas monitoring of the patients in the control group will be performed at maximum 4-hour intervals, and respiratory parameters will be frequently evaluated and recorded.

NCT ID: NCT06065696 Completed - Anesthesia Clinical Trials

Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery

Start date: February 1, 2023
Phase:
Study type: Observational

Early mobilization is an important factor in increasing postoperative colorectal surgeries outcome. There are four components held by anesthesiologist in Enhanced Recovery After Surgery protocol for colorectal surgery in our hospital: post operative nausea and vomiting (PONV) prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management. Although early mobilization affected by postoperative pain, vomiting and nausea, and fluid balance management, nonetheless, there is no clear evidence of how much each of these components will affect early mobilization.

NCT ID: NCT05953649 Not yet recruiting - Clinical trials for Mechanical Ventilation

Effect of Early Extracorporeal Diaphragm Pacing Combined With Tilt Table in Ventilated Patients.

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to test the effect of 1week of extracorporeal diaphragm pacing (EDP) combined either with or without tilt table verticalization (TTV) on diaphragm function in patients with mechanical ventilation compared to conventional physiotherapy (CPT).

NCT ID: NCT05830682 Completed - Pain Clinical Trials

Effect of Using Walking Aid on Mobility

Start date: January 29, 2019
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effect of using walking aid during out-of-bed mobilization of patients who underwent open coronary artery bypass graft surgery on levels of pain and mobility. The main hypotheses are: 1. The pain level of patients using walking aid is lower than that of those who do not. 2. The mobility level of patients using walking aid is higher than that of those who do not. Participants will be asked to walk with using a walking aid during the first three mobilizations in the intensive care unit on the first postoperative day.

NCT ID: NCT05591950 Recruiting - Critical Illness Clinical Trials

Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)

TAVIMS
Start date: January 24, 2023
Phase:
Study type: Observational

Intensive care unit acquired weakness (ICUAW) is a common issue in critically ill patients. Early mobilization can reduce the occurrence of ICUAW. This requires a standardized procedure based on validated scales. One such scale is Carol Hodgson's ICU Mobility Scale (IMS). The subject of the study is the translation of the IMS into German and the validation of its reliability and predictive power with regard to various clinical outcomes. Furthermore we want to investigate the communication about the mobilisation status of ICU-patients between the different medical disciplines that are involved in patient care.

NCT ID: NCT04750265 Completed - Covid19 Clinical Trials

Robotic Assisted Early Mobilization in Ventilated ICU Patients With COVID-19

Start date: March 29, 2021
Phase: N/A
Study type: Interventional

Feasibility trial investigating the potential higher frequency of robotic assisted early mobilization in intubated COVID19 patients on the ICU.

NCT ID: NCT04648488 Not yet recruiting - Elbow Fracture Clinical Trials

Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The purpose with the study is to evalute if early mobilsation after surgery in patients vid elbow frakture-dislocation may lead to better armfunction and reduce common complications as stiffnes in the elbow. After surgery patients will be randomised to either early mobilisation (exercise treatment 3 Days after surgery) or ordinary treatment (plaster and exercise treatment 3 weeks after surgery).

NCT ID: NCT04593602 Withdrawn - Older Adults Clinical Trials

Early Mobilization in Older Adults With Acute Cardiovascular Disease

EM-HEART
Start date: April 1, 2023
Phase: Phase 3
Study type: Interventional

The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic early mobilization (EM) program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization.