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

Primary Purpose

Critical Illness, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Conventional Physical Therapy
Early and progressive mobilization program
Respiratory therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Intensive Care Units, Physical Therapy Specialty, Critical illness, Muscle weakness, Bed rest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Protocol group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Functional status
Ability to perform daily living activities assessed by Barthel Index

Secondary Outcome Measures

Level of physical activity during the whole intensive care unit stay
Level of physical activity measured by an accelerometer
Pulmonary function
Pulmonary function assessed by a spirometer
Maximum inspiratory pressure
Maximum inspiratory pressure measured by an specific equipment
Peripheral muscle strength
Muscle strength assessed by hand grip dynamometer
Electromyography muscle activity
Quadriceps femoris electric activity assessed by surface electromyography
Muscle function and mobility
Test by Time up and Go
Intensive care unit length of stay
Count of the number of days spent at the intensive care unit
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
ICU mobility Scale
Measure of mobility milestones in critically ill patients.
Long term follow up
Longer-term follow-up for functional status by Barthel Index 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

Full Information

First Posted
March 3, 2016
Last Updated
November 28, 2018
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02889146
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Muscle Weakness
Keywords
Intensive Care Units, Physical Therapy Specialty, Critical illness, Muscle weakness, Bed rest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Protocol group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
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
Intervention Name(s)
Early and progressive mobilization program
Intervention Description
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
Intervention Name(s)
Respiratory therapy
Intervention Description
Respiratory therapy according to the service routine.
Primary Outcome Measure Information:
Title
Functional status
Description
Ability to perform daily living activities assessed by Barthel Index
Time Frame
At the time of discharge from the ICU, at least 4 days after admission.
Secondary Outcome Measure Information:
Title
Level of physical activity during the whole intensive care unit stay
Description
Level of physical activity measured by an accelerometer
Time Frame
At the time of discharge from the ICU, at least 4 days after admission.
Title
Pulmonary function
Description
Pulmonary function assessed by a spirometer
Time Frame
At the time of discharge from the ICU, at least 4 days after admission.
Title
Maximum inspiratory pressure
Description
Maximum inspiratory pressure measured by an specific equipment
Time Frame
At the time of discharge from the ICU, at least 4 days after admission.
Title
Peripheral muscle strength
Description
Muscle strength assessed by hand grip dynamometer
Time Frame
At the time of discharge from the ICU, at least 4 days after admission.
Title
Electromyography muscle activity
Description
Quadriceps femoris electric activity assessed by surface electromyography
Time Frame
At the time of discharge from the ICU, at least 4 days after admission.
Title
Muscle function and mobility
Description
Test by Time up and Go
Time Frame
At the time of discharge from the ICU, at least 4 days after admission.
Title
Intensive care unit length of stay
Description
Count of the number of days spent at the intensive care unit
Time Frame
At the time of discharge from the ICU, at least 4 days after admission.
Title
Correlation between physiological variables and the level of physical activity
Description
Correlation between the physiological variables collected during the study and the level of physical activity measured by the accelerometer
Time Frame
At the time of discharge from the ICU, at least 4 days after admission.
Title
ICU mobility Scale
Description
Measure of mobility milestones in critically ill patients.
Time Frame
Through study completion, an average of 2 weeks
Title
Long term follow up
Description
Longer-term follow-up for functional status by Barthel Index after three months and one year of discharge
Time Frame
After three months and one year of discharge
Title
Level of activity by Perceived Exertion
Description
Level of exercise by Perceived Exertion by Borg Rating of Perceived Exertion Scale
Time Frame
approximately 40 minutes after therapy, immediately after the end of the protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Fu, PhD
Organizational Affiliation
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05360-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31967219
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.
Results Reference
derived
PubMed Identifier
29747662
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.
Results Reference
derived

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

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