Progressive Mobility Program and Technology to Improve the Level of Physical Activity and Functionality of ICU Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-11-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to verify if a protocol of early and progressive mobility which includes the use of technology is able to increase the level of physical activity and improve functionality and respiratory and muscular function of Intensive Care Unit patients compared with conventional Physical Therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06405529

Early Mobilization Physiotherapy Rehabilitation

NOT_YET_RECRUITING NA

Tolerance of Early Exercise in Intensive Care Unit

NCT02408250

Critical Illness

COMPLETED

Early Physical Therapy in Patients With Sepsis

NCT01787045

SEPTIC SHOCK SEPSIS SYNDROME Multiple Organ Dysfunction Syndrome

TERMINATED NA

Effectiveness of Therapeutic Exercise Combined With Respiratory Muscle Training in Patients With Subacute Stroke

NCT06949839

Stroke

NOT_YET_RECRUITING NA

Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile

NCT04228224

Stroke

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The evolution of treatment in the Intensive Care Unit (ICU) has increased the survival and morbidity post hospital. Functional disability in these patients has its main factor in the weakness and loss of muscle mass, which is the major complications reported by these patients. The most negative result in long-term post ICU is the impact on quality of life and functional decline due to muscle disorders and fitness. This is achieved by the period of inactivity and prolonged rest, leading to losses and changes in various body systems. Given these facts, interventions for greater mobility in bed and out of it are very important. Early mobility programs has proved beneficial, however, as in other types of rehabilitation, the exercises should be prescribed with its specific characteristics, including the intensity. However, little has been described in the researches abut the activity level in the ICU, and using a quantitative measure. The use of technology seems to facilitate the offering of this type of therapy, supplying the limitations. Therefore, there are little evidences about these topics and randomized controlled studies to investigate these factors.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Muscle Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Conventional Physical Therapy: motor physical therapy delivered by the intensive care unit physical therapists, according to his own criteria, without following any protocol. Respiratory therapy.

Group Type ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type OTHER

Control group will receive respiratory therapy according to the service routine and conventional physical therapy. Conventional physical therapy will be offered by the hospital physical therapists, according to their own criteria. Consists of passive, assisted and resisted mobilization, positioning in bed, transferring to bedside or chair, orthostatism and deambulation, however without a definition of a protocol. The physical therapist will be responsible for the choice of the techniques employed in each session. There will be no previous definition of the next sessions. No technology equipment will be used in this group, since they are not available in the routine care.

Respiratory therapy

Intervention Type OTHER

Respiratory therapy according to the service routine.

Protocol group

Early and progressive mobilization program: motor physical therapy delivered by a trained physical therapist according to the mobilization protocol, in which patient progress according to his performance. Respiratory therapy.

Group Type EXPERIMENTAL

Early and progressive mobilization program

Intervention Type OTHER

Protocol group will receive respiratory therapy according to the service routine and motor physical therapy according to the program of early and progressive mobilization. Patients will receive the program once daily during the intensive care unit stay, offered by a trained physical therapist, at the adequate level according to the level of consciousness and muscle strength. The program contains by techniques for muscle length and muscle strength maintenance or gain, aerobic exercises, exercises for gait rehabilitation and cognitive components. Patient will progress to the next level of the protocol completing the previous level. Technology equipment available: functional electrical stimulation device, dumbbells, cycle ergometer, fixed walker, ambulation assistive device and video game.

Respiratory therapy

Intervention Type OTHER

Respiratory therapy according to the service routine.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional Physical Therapy

Control group will receive respiratory therapy according to the service routine and conventional physical therapy. Conventional physical therapy will be offered by the hospital physical therapists, according to their own criteria. Consists of passive, assisted and resisted mobilization, positioning in bed, transferring to bedside or chair, orthostatism and deambulation, however without a definition of a protocol. The physical therapist will be responsible for the choice of the techniques employed in each session. There will be no previous definition of the next sessions. No technology equipment will be used in this group, since they are not available in the routine care.

Intervention Type OTHER

Early and progressive mobilization program

Protocol group will receive respiratory therapy according to the service routine and motor physical therapy according to the program of early and progressive mobilization. Patients will receive the program once daily during the intensive care unit stay, offered by a trained physical therapist, at the adequate level according to the level of consciousness and muscle strength. The program contains by techniques for muscle length and muscle strength maintenance or gain, aerobic exercises, exercises for gait rehabilitation and cognitive components. Patient will progress to the next level of the protocol completing the previous level. Technology equipment available: functional electrical stimulation device, dumbbells, cycle ergometer, fixed walker, ambulation assistive device and video game.

Intervention Type OTHER

Respiratory therapy

Respiratory therapy according to the service routine.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* admitted to the Emergency Intensive Care Unit of Clinical Hospital, Medical School, University os Sao Paulo
* inspired oxygen fraction ≤ 60%
* positive end expiratory pressure ≤ 10 points
* peripheral oxygen saturation ≥ 90%
* respiratory rate ≤ 35
* without cardiac arrhythmia or acute ischaemia
* heart rate \> 50 bpm and \< 140 bpm
* without high or raising dose of vasoactive drugs
* mean body pressure \> 60 mmHg and \< 120 mmHg
* without active bleeding
* without prescribed bedrest