Critically IllNCT03596853
Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients
A study testing Progressive mobilization in people with Critically Ill, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
Immobilization and bed rest of patients in intensive care units (ICU) increases their risk for muscle dysfunction and prolonged mechanical ventilation, leading to physical deconditioning and loss of functionality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill
- What is being tested?
- Progressive mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being able to roll in the bed and bridge.
- Barthel score of at least 70 weeks before admission to the ICU
- Ability to interact with the researcher
Who cannot join
- Mortality rate in excess of 50% according to Acute Physiology and Chronic Health Disease Classification System II (APACHEII)
- Present intracranial pressure increase
- Cardiorespiratory arrest,
- Has unstable fractures that hamper progression in levels of mobilization,
- Severe lower limb injury or amputation
- Neuromuscular disease
- Underwent radiotherapy and / or chemotherapy in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Addition of a Protocol of Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients: Randomized Controlled Trial
Immobilization and bed rest of patients in intensive care units (ICU) increases their risk for muscle dysfunction and prolonged mechanical ventilation, leading to physical deconditioning and loss of functionality. Active mobilization is a therapeutic strategy that typically involves exercises in which the patient uses his or her own strength and muscular control, is a feasible, safe, and low-cost intervention to improve muscle dysfunction and disability in patients at the ICU. Despite scientific advances, the current description and prescriptions of exercises at the ICU remain incomplete with respect to the control and the description of the variables of training load (volume and intensity), programming, and progression.
Read the detailed description
This prospective double-blind (patient and evaluator). This study will be conducted in accordance with Consolidated Standards of Reporting Trials recommendations. The trial will be performed at the University Hospital Professor Edgard Santos in Salvador, Bahia, Brazil. This study was approved by the institutional hospital ethics committee (approval reference number 2.371.933). Before enrollment, written informed consent will be obtained from participants or their legal guardians.
- Conditions
- Critically Ill
- Being tested
- Progressive mobilization, Usual Care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive mobilizationOther
Will be applied once a day, 5x/ week, performed into 4 levels: N1 (bridge and rolling for both sides); N2 (transfer training from lying down to sitting on both sides); N3 (sit and stand up from a chair); N4 (running training). According to their functional level, patients will perform, once a day, 8 sets of each movement, alternating 20 seconds of execution with 10 seconds of rest. Patients will be stimulated constantly to perform the movements with the highest possible speed.
If the patient performs adequately within of your level functional level, can will progress in level, if can not progress, there will be an increase in training volume within the level itself. Adequate performance within the functional level means that the patient is able to complete more than eight sets of exercise and does not present increased sensation of pain, present sensation of perceived exertion within the safety limit of the protocol (Borg ≤ 6).
Usual CareOther
This group will receive standard usual, which will be monitored, but not protocolised.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Mobilization | Experimental | These patients will receive standard rehabilitation delivered by non-study physiotherapist. In addition, the patients will undergo a protocol of progressive mobilization with individualized dose control and training load stratified according to functional levels and performance. Receives: Other: Progressive mobilization |
| Control: Usual care | Sham comparator | These patients will receive standard rehabilitation delivered by non-study physiotherapist. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ICU stay in days
Time in days, from baseline to discharge from ICU
Measured: at 28 days or discharge from ICU whichever occurs earlier
Secondary outcomes (12)
Muscle mass
Ultrasound measurement (quadriceps, biceps brachii, and diaphragm - cross-sectional area on B-mode ultrasound
Measured: Change from baseline at 28th day
Change in muscle strength
Muscle Strength measured by hand held dynamometer
Measured: Baseline and after 3 and at 7 day intervals up to 28th day or discharge from ICU
Physical activity: total activity
accelerometry measurement of the total activity
Measured: At 28 days or discharge from hospital
Activity and participation
Measurement characteristics of World Health Organisation Disability Assessment Schedule II
Measured: Change from baseline up to 1 year post discharge
Mortality
Mortality
Measured: At 28 days or discharge from hospital and at 12 months
Functional Status
Functional Status Measured Using Functional Status Score for the Intensive Care Unit (involves five functional tasks (rolling, supine to sit transfer, sit to stand transfer, sitting on the edge of bed and walking). Each task is evaluated using an 8-point ordinal scale ranging from 0 (not able to perform at all) to 7 (complete independence)
Measured: Change from baseline up to 28th day or discharge from hospital
Surgical Optimal Mobilisation Score (SOMS) level
Surgical Optimal Mobilisation Score (SOMS) level algorithm for goal-directed mobility ranges from '0-No mobility' to '4-Ambulation'. The intermediate steps are '1-Passive Range of Motion,' '2-Sitting,' and '3-Standing.'
Measured: Change from baseline up to 28th day or discharge from hospital
Mobility
Timed up-and-go score
Measured: Change from baseline up to 28th day or discharge from hospital
Health-Related Quality of Life: SF-36
Health-Related Quality of Life will be measured by a questionnaire 36-item Short Form Health Survey. The SF-36 is a widely used generic instrument for evaluating HRQoL, consisting of eight subscales evaluating specific health status domains and two summary scales, a Physical Component Summary and a Mental Component Summary. Scores on the SF-36 range from 0 to 100, with higher scores indicating better health status.
Measured: At 28 days or discharge from hospital and at 12 months
Days with mechanical ventilation
Number of uninterrupted days in use of mechanical ventilation
Measured: From 3 to 28 days
Length of hospital stay in days
Time in days, from baseline to discharge from hospital
Measured: Up to 1 month post hospital discharge
Muscle thickness
Ultrasound measurement (quadriceps, biceps brachii, and diaphragm on B-mode ultrasound measured in mm
Measured: Change from baseline at 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Jun 2019 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansueto Gomes Neto, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596853
- Sponsor's protocol ID
- FUBahia Mobilization ICU
- Status last verified
- Apr 2019
- First submitted
- 21 Jun 2018
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Addition of a Protocol of Progressive Mobilization With Dose Control and Training Load in in Critically Ill Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03596853
- Acronym / sponsor ID
- FUBahia Mobilization ICU
- Conditions
- Critically Ill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immobilization and bed rest of patients in intensive care units (ICU) increases their risk for muscle dysfunction and prolonged mechanical ventilation, leading to physical deconditioning and loss of functionality. Active mobilization is a therapeutic strategy that typically involves exercises in which the patient uses his or her own strength and muscular control, is a feasible, safe, and low-cost intervention to improve muscle dysfunction and disability in patients at the ICU. Despite scientific advances, the current description and prescriptions of exercises at the ICU remain incomplete with respect to the control and the description of the variables of training load (volume and intensity), programming, and progression.
Detailed description
This prospective double-blind (patient and evaluator). This study will be conducted in accordance with Consolidated Standards of Reporting Trials recommendations. The trial will be performed at the University Hospital Professor Edgard Santos in Salvador, Bahia, Brazil. This study was approved by the institutional hospital ethics committee (approval reference number 2.371.933). Before enrollment, written informed consent will be obtained from participants or their legal guardians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Mobilization | Experimental | Other: Progressive mobilizationThese patients will receive standard rehabilitation delivered by non-study physiotherapist. In addition, the patients will undergo a protocol of progressive mobilization with individualized dose control and training load stratified according to functional levels and performance. |
| Control: Usual care | Sham comparator | Other: Usual CareThese patients will receive standard rehabilitation delivered by non-study physiotherapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being able to roll in the bed and bridge.
- Barthel score of at least 70 weeks before admission to the ICU
- Ability to interact with the researcher
Key exclusion criteria (7 listed)
- Mortality rate in excess of 50% according to Acute Physiology and Chronic Health Disease Classification System II (APACHEII)
- Present intracranial pressure increase
- Cardiorespiratory arrest,
- Has unstable fractures that hamper progression in levels of mobilization,
- Severe lower limb injury or amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive mobilizationWill be applied once a day, 5x/ week, performed into 4 levels: N1 (bridge and rolling for both sides); N2 (transfer training from lying down to sitting on both sides); N3 (sit and stand up from a chair); N4 (running training). According to their functional level, patients will perform, once a day, 8 sets of each movement, alternating 20 seconds of execution with 10 seconds of rest. Patients will be stimulated constantly to perform the movements with the highest possible speed. If the patient performs adequately within of your level functional level, can will progress in level, if can not progress, there will be an increase in training volume within the level itself. Adequate performance within the functional level means that the patient is able to complete more than eight sets of exercise and does not present increased sensation of pain, present sensation of perceived exertion within the safety limit of the protocol (Borg ≤ 6). | Other | Experimental: Mobilization |
| Usual CareThis group will receive standard usual, which will be monitored, but not protocolised. | Other | Control: Usual care |
Primary outcome
Length of ICU stay in days
Time frame: at 28 days or discharge from ICU whichever occurs earlier
Time in days, from baseline to discharge from ICU
12 secondary outcomes
Muscle mass
Time frame: Change from baseline at 28th day
Change in muscle strength
Time frame: Baseline and after 3 and at 7 day intervals up to 28th day or discharge from ICU
Physical activity: total activity
Time frame: At 28 days or discharge from hospital
Activity and participation
Time frame: Change from baseline up to 1 year post discharge
Mortality
Time frame: At 28 days or discharge from hospital and at 12 months
Functional Status
Time frame: Change from baseline up to 28th day or discharge from hospital
Surgical Optimal Mobilisation Score (SOMS) level
Time frame: Change from baseline up to 28th day or discharge from hospital
Mobility
Time frame: Change from baseline up to 28th day or discharge from hospital
Health-Related Quality of Life: SF-36
Time frame: At 28 days or discharge from hospital and at 12 months
Days with mechanical ventilation
Time frame: From 3 to 28 days
Length of hospital stay in days
Time frame: Up to 1 month post hospital discharge
Muscle thickness
Time frame: Change from baseline at 28th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive mobilization in people with Critically Ill, run by Federal University of Bahia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of ICU stay in days (time frame: at 28 days or discharge from ICU whichever occurs earlier). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019; AzTrials last refreshed its copy on 29 Oct 2026.