Muscle WeaknessNCT01769846
The Impact of Early Mobilization Protocol in Patients in the ICU
A study testing Early mobilization protocol in people with Muscle Weakness and Quality of Life, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
Advances in intensive care and mechanical ventilation (MV) in the past two decades have increased critically ill patient survival. However, some patients require prolonged MV (PMV) and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse effects of medications, and prolonged… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Weakness, Quality of Life, Weaning Acceleration
- What is being tested?
- Early mobilization protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Aug 2018
- 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
- Adults (18 years of age or greater)
- Patients in the first 24 hours of mechanical ventilation.
- Patients in the deep sedation will be evaluated by the Richmond Agitation-Sedation Scale (score -4).
- Hemodynamically stable.
Who cannot join
- Rapidly developing neuromuscular disease
- Evolution of brain death
- Cardiopulmonary arrest
- Elevated intracranial pressure
- Ruptured/leaking aortic aneurysm
- Acute MI before peak troponin has been reached
Show all 11Show fewer
- Absent lower limb
- Pregnancy
- Unstable fractures contributing to likely immobility
- Hospitalization prior to ICU admission >5 days
- Enrollment in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.
Advances in intensive care and mechanical ventilation (MV) in the past two decades have increased critically ill patient survival. However, some patients require prolonged MV (PMV) and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse effects of medications, and prolonged immobilization. Patients in the intensive care unit (ICU) are often confined to their beds, which results in inactivity, immobility, and severe osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol improves muscle thickness (MT) of the quadriceps femoris, peripheral muscle strength, perceived functional status, gait speed, quality of life, duration of mechanical ventilation, ICU length of stay of the critically ill patient.
The purpose of this study is to evaluate the effects of implementation an early mobilization protocol in critically ill patients in the Intensive Care Unit of the University Hospital of Santa Maria.
- Conditions
- Muscle Weakness, Quality of Life, Weaning Acceleration, ICU Length of Stay, Muscle Thickness of the Quadriceps Femoris
- Being tested
- Early mobilization protocol
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilization protocolOther
Patients in the treatment group additionally received a cycling exercise session 7 days a week, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH \& Co. KG, Betzenweiler, Germany). The device offers the possibility to conduct passive or active cycling at six levels of increasing resistance. The aim of each session was to have the patient cycle for 30 mins at an individually adjusted intensity level. Patients were placed in a comfortable position in between the supine and the semirecumbent position.
| Study group | Role | What they receive |
|---|---|---|
| Early Mobilization protocol | Experimental | Early Mobilization protocol: Patients in the treatment group additionally received a progressive cycling exercise session 7 days a week, until the last day of ICU stay, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH \& Co. KG, Betzenweiler, Germany). Cycling exercise will be realized during 30 consecutive minutes, initially in continuos and passive (classified patients with RASS - 4) exercise, at a fixed pedaling rate of 20 cycles/min and after in actively (classified patients with RASS 0), with an exercise intensity of 3-5 on the Borg rate of perceived exertion scale. Receives: Other: Early mobilization protocol |
| Control group | No intervention | Group will undergo usual mobilization per standard ICU care. Conventional physical and respiratory therapy were provided by the ICU physical therapists twice daily, for approximately 30 min, 7 days per week. The protocol included vibrocompression maneuvers; lung hyperinflation by the mechanical ventilator; and tracheal aspiration, when necessary; as well as passive and active-assisted motor exercises for arms and legs, depending on the clinical course of patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness (MT) of the quadriceps femoris.
MT of the quadriceps femoris will be assessed by ultrasonography (baseline and 14 day).
Measured: Change from baseline at 14 day of ICU admission, an average of 1 month.
Muscle thickness (MT) of the diaphragm.
MT of the diaphragm will be assessed by ultrasonography (baseline and 14 day).
Measured: Change from baseline at 14 day of ICU admission, an average of 1 month.
Secondary outcomes (12)
Rectus femoris cross-sectional area
Rectus femoris cross-sectional area will be assessed by ultrasonography (baseline and 14 day).
Measured: Change from baseline at 14 day of ICU admission, an average of 1 month.
Vastus intermedius, rectus femoris and diaphragm echo intensity.
Vastus intermedius, rectus femoris and diaphragm echo intensity will be assessed by ultrasonography (baseline and 14 day)
Measured: Change from baseline at 14 day of ICU admission, an average of 1 month.
Rectus femoris and vastus intermedius thickness.
Rectus femoris and vastus intermedius thickness will be assessed by ultrasonography (baseline and 14 day).
Measured: Change from baseline at 14 day of ICU admission, an average of 1 month.
Muscle strength
Muscle strength in arms and legs will be measured by the Medical Research Council (MRC) scale.
Measured: First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month.
Gait speed
Gait speed will be measured by the six-meter gait speed test (GST)
Measured: Study completion, an average of 2 months (hospital discharge)
Peripheral muscle strength of the lower limbs
Peripheral muscle strength of the lower limbs will be measured by 30 second chair stand test
Measured: Study completion, an average of 2 months (hospital discharge)
Quality of life following hospital discharge
Quality of life will be measured by a questionnaire 36-item Short Form Health Survey
Measured: Three months after hospital discharge SF36
Mortality
Measured: Patients will be followed until three months after hospital discharge
ICU length of stay
Measured: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks.
Weaning Acceleration
Measured: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks
Side effects of mobilization protocol
Haemodynamic response to mobilization. Response in systolic and diastolic blood pressure. Response in heart rate. Response in peripheral oxygen saturation.
Measured: During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks.
Length of hospital stay
Measured: Patients will be followed until hospital discharge, an expected 4 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startMar 2015
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabella Martins de Albuquerque, Universidade Federal de Santa Maria
- Investigators
- Isabella Albuquerque, DSc., Principal investigator, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769846
- Sponsor's protocol ID
- 07201712.8.0000.5346
- Status last verified
- Oct 2018
- First submitted
- 11 Jan 2013
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Machado ADS, Pires-Neto RC, Carvalho MTX, Soares JC, Cardoso DM, Albuquerque IM. Effects that passive cycling exercise have on muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients: a randomized clinical trial. J Bras Pneumol. 2017 Mar-Apr;43(2):134-139. doi: 10.1590/S1806-37562016000000170.
PubMed 28538781
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Mobilization Protocol in Patients in the ICU of the University Hospital of Santa Maria.
- ClinicalTrials.gov ID
- NCT01769846
- Acronym / sponsor ID
- 07201712.8.0000.5346
- Conditions
- Muscle Weakness, Quality of Life, Weaning Acceleration, ICU Length of Stay, Muscle Thickness of the Quadriceps Femoris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 17 Jan 2013 (estimated)
- 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.
Advances in intensive care and mechanical ventilation (MV) in the past two decades have increased critically ill patient survival. However, some patients require prolonged MV (PMV) and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse effects of medications, and prolonged immobilization. Patients in the intensive care unit (ICU) are often confined to their beds, which results in inactivity, immobility, and severe osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol improves muscle thickness (MT) of the quadriceps femoris, peripheral muscle strength, perceived functional status, gait speed, quality of life, duration of mechanical ventilation, ICU length of stay of the critically ill patient.
The purpose of this study is to evaluate the effects of implementation an early mobilization protocol in critically ill patients in the Intensive Care Unit of the University Hospital of Santa Maria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Mobilization protocol | Experimental | Other: Early mobilization protocolEarly Mobilization protocol: Patients in the treatment group additionally received a progressive cycling exercise session 7 days a week, until the last day of ICU stay, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH \& Co. KG, Betzenweiler, Germany). Cycling exercise will be realized during 30 consecutive minutes, initially in continuos and passive (classified patients with RASS - 4) exercise, at a fixed pedaling rate of 20 cycles/min and after in actively (classified patients with RASS 0), with an exercise intensity of 3-5 on the Borg rate of perceived exertion scale. |
| Control group | No intervention | –Group will undergo usual mobilization per standard ICU care. Conventional physical and respiratory therapy were provided by the ICU physical therapists twice daily, for approximately 30 min, 7 days per week. The protocol included vibrocompression maneuvers; lung hyperinflation by the mechanical ventilator; and tracheal aspiration, when necessary; as well as passive and active-assisted motor exercises for arms and legs, depending on the clinical course of patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (18 years of age or greater)
- Patients in the first 24 hours of mechanical ventilation.
- Patients in the deep sedation will be evaluated by the Richmond Agitation-Sedation Scale (score -4).
- Hemodynamically stable.
Key exclusion criteria (11 listed)
- Rapidly developing neuromuscular disease
- Evolution of brain death
- Cardiopulmonary arrest
- Elevated intracranial pressure
- Ruptured/leaking aortic aneurysm
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 |
|---|---|---|
| Early mobilization protocolPatients in the treatment group additionally received a cycling exercise session 7 days a week, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH \& Co. KG, Betzenweiler, Germany). The device offers the possibility to conduct passive or active cycling at six levels of increasing resistance. The aim of each session was to have the patient cycle for 30 mins at an individually adjusted intensity level. Patients were placed in a comfortable position in between the supine and the semirecumbent position. | Other | Early Mobilization protocol |
Primary outcome
Muscle thickness (MT) of the quadriceps femoris.
Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.
MT of the quadriceps femoris will be assessed by ultrasonography (baseline and 14 day).
Muscle thickness (MT) of the diaphragm.
Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.
MT of the diaphragm will be assessed by ultrasonography (baseline and 14 day).
12 secondary outcomes
Rectus femoris cross-sectional area
Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.
Vastus intermedius, rectus femoris and diaphragm echo intensity.
Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.
Rectus femoris and vastus intermedius thickness.
Time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.
Muscle strength
Time frame: First day of the patient was cooperative and responsive and at day 14 of ICU admission, an average of 1 month.
Gait speed
Time frame: Study completion, an average of 2 months (hospital discharge)
Peripheral muscle strength of the lower limbs
Time frame: Study completion, an average of 2 months (hospital discharge)
Quality of life following hospital discharge
Time frame: Three months after hospital discharge SF36
Mortality
Time frame: Patients will be followed until three months after hospital discharge
ICU length of stay
Time frame: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks.
Weaning Acceleration
Time frame: Patients will be followed until ICU discharge, an expected 2 days to 3 weeks
Side effects of mobilization protocol
Time frame: During and 30 minutes after mobilization therapy during ICU stay, approximately 1 to 2 weeks.
Length of hospital stay
Time frame: Patients will be followed until hospital discharge, an expected 4 to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 28538781Machado ADS, Pires-Neto RC, Carvalho MTX, Soares JC, Cardoso DM, Albuquerque IM. Effects that passive cycling exercise have on muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients: a randomized clinical trial. J Bras Pneumol. 2017 Mar-Apr;43(2):134-139. doi: 10.1590/S1806-37562016000000170.
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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.
Isabella Albuquerque, DSc. principal investigator
Universidade Federal de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization protocol in people with Muscle Weakness and Quality of Life, run by Universidade Federal de Santa Maria 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 11 Oct 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle thickness (MT) of the quadriceps femoris. (time frame: Change from baseline at 14 day of ICU admission, an average of 1 month.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769846, which also lists 1 linked publication.
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 11 Oct 2018.