Clinical trial NCT02889146: Progressive Mobility Program and Technology to Improve the Level of Physical Activity and Functionality of ICU Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Muscle Weakness
Keywords: Intensive Care Units
Physical Therapy Specialty
Critical illness
Muscle weakness
Bed rest
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-09-05
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Exclusion Criteria:

* transference from other hospital
* diagnosis of neurological disorders
* intensive care unit stay \< 4 days
* contraindication to mobilization

Primary outcomes:
measure: Functional status
timeFrame: At the time of discharge from the ICU, at least 4 days after admission.
Secondary outcomes:
measure: Level of physical activity during the whole intensive care unit stay
timeFrame: At the time of discharge from the ICU, at least 4 days after admission.
measure: Pulmonary function
timeFrame: At the time of discharge from the ICU, at least 4 days after admission.
measure: Maximum inspiratory pressure
timeFrame: At the time of discharge from the ICU, at least 4 days after admission.
measure: Peripheral muscle strength
timeFrame: At the time of discharge from the ICU, at least 4 days after admission.
measure: Electromyography muscle activity
timeFrame: At the time of discharge from the ICU, at least 4 days after admission.
measure: Muscle function and mobility
timeFrame: At the time of discharge from the ICU, at least 4 days after admission.
measure: Intensive care unit length of stay
timeFrame: At the time of discharge from the ICU, at least 4 days after admission.
measure: Correlation between physiological variables and the level of physical activity
timeFrame: At the time of discharge from the ICU, at least 4 days after admission.
measure: ICU mobility Scale
timeFrame: Through study completion, an average of 2 weeks
measure: Long term follow up
timeFrame: After three months and one year of discharge
measure: Level of activity by Perceived Exertion
timeFrame: approximately 40 minutes after therapy, immediately after the end of the protocol
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo
state: SP
Study officials:
affiliation: Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo
name: Carolina Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomes TT, Schujmann DS, Fu C. Rehabilitation through virtual reality: physical activity of patients admitted to the intensive care unit. Rev Bras Ter Intensiva. 2019 Oct-Dec;31(4):456-463. doi: 10.5935/0103-507X.20190078.
citation: Schujmann DS, Lunardi AC, Fu C. Progressive mobility program and technology to increase the level of physical activity and its benefits in respiratory, muscular system, and functionality of ICU patients: study protocol for a randomized controlled trial. Trials. 2018 May 10;19(1):274. doi: 10.1186/s13063-018-2641-4.