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

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889146
• Other study ID #: deborass
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: November 28, 2018

Study information

• Verified date: November 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Muscle Weakness
• Paresis

Intervention

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.
• 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.
• Respiratory therapy
Respiratory therapy according to the service routine.

Locations

Country	Name	City	State
Brazil	Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional status	Ability to perform daily living activities assessed by Barthel Index	At the time of discharge from the ICU, at least 4 days after admission.
Secondary	Level of physical activity during the whole intensive care unit stay	Level of physical activity measured by an accelerometer	At the time of discharge from the ICU, at least 4 days after admission.
Secondary	Pulmonary function	Pulmonary function assessed by a spirometer	At the time of discharge from the ICU, at least 4 days after admission.
Secondary	Maximum inspiratory pressure	Maximum inspiratory pressure measured by an specific equipment	At the time of discharge from the ICU, at least 4 days after admission.
Secondary	Peripheral muscle strength	Muscle strength assessed by hand grip dynamometer	At the time of discharge from the ICU, at least 4 days after admission.
Secondary	Electromyography muscle activity	Quadriceps femoris electric activity assessed by surface electromyography	At the time of discharge from the ICU, at least 4 days after admission.
Secondary	Muscle function and mobility	Test by Time up and Go	At the time of discharge from the ICU, at least 4 days after admission.
Secondary	Intensive care unit length of stay	Count of the number of days spent at the intensive care unit	At the time of discharge from the ICU, at least 4 days after admission.
Secondary	Correlation between physiological variables and the level of physical activity	Correlation between the physiological variables collected during the study and the level of physical activity measured by the accelerometer	At the time of discharge from the ICU, at least 4 days after admission.
Secondary	ICU mobility Scale	Measure of mobility milestones in critically ill patients.	Through study completion, an average of 2 weeks
Secondary	Long term follow up	Longer-term follow-up for functional status by Barthel Index after three months and one year of discharge	After three months and one year of discharge
Secondary	Level of activity by Perceived Exertion	Level of exercise by Perceived Exertion by Borg Rating of Perceived Exertion Scale	approximately 40 minutes after therapy, immediately after the end of the protocol