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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Muscle Weakness
• Intervention / Treatment: Other: Conventional Physical Therapy; Other: Respiratory therapy; Other: Early and progressive mobilization program

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05360-000
      • Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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: Respiratory therapy; Respiratory therapy according to the service routine.
Experimental: 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.	Other: Respiratory therapy; Respiratory therapy according to the service routine.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Pulmonary function	Pulmonary function assessed by a spirometer	At the time of discharge from the ICU, at least 4 days after admission.
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.
Peripheral muscle strength	Muscle strength assessed by hand grip dynamometer	At the time of discharge from the ICU, at least 4 days after admission.
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.
Muscle function and mobility	Test by Time up and Go	At the time of discharge from the ICU, at least 4 days after admission.
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.
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.
ICU mobility Scale	Measure of mobility milestones in critically ill patients.	Through study completion, an average of 2 weeks
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
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Carolina Fu, PhD, Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Critical illness; Physical Therapy Specialty; Intensive Care Units; Muscle weakness; Bed rest
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Critical Illness; Paresis
• Other Study ID Numbers: deborass

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No