NCT02889146

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

Using a Progressive Mobility Program and Technology to Increase the Level of Physical Activity and Its Benefits in Respiratory, Muscular System and Functionality of ICU Patients: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Critical Illness
• Muscle Weakness

Interventions

Type	Name	Description
OTHER	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.
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.
OTHER	Respiratory therapy	Respiratory therapy according to the service routine.

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-11-28
• Completion: 2018-11-28
• First posted: 2016-09-05
• Last updated: 2018-11-29

Locations

1 site across 1 country: Brazil