Critical IllnessNCT02889146
Progressive Mobility Program and Technology to Improve the Level of Physical Activity and Functionality of ICU Patients
A study testing Conventional Physical Therapy, Early and progressive mobilization program and Respiratory therapy in people with Critical Illness and Muscle Weakness, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Muscle Weakness
- What is being tested?
- Conventional Physical Therapy, Early and progressive mobilization program and Respiratory therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2017to 28 Nov 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
- 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
Show all 11Show fewer
- 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
Who cannot join
- transference from other hospital
- diagnosis of neurological disorders
- intensive care unit stay < 4 days
- contraindication to mobilization
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo
São Paulo, São Paulo, 05360-000
About this study
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
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.
Read the 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.
- Conditions
- Critical Illness, Muscle Weakness
- Being tested
- Conventional Physical Therapy, Early and progressive mobilization program, Respiratory therapy
- Keywords
- Intensive Care Units, Physical Therapy Specialty, Critical illness, Muscle weakness, Bed rest
- Medical subject headings
- Critical Illness, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Physical TherapyOther
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 programOther
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 therapyOther
Respiratory therapy according to the service routine.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Other: Conventional Physical Therapy; Other: Respiratory therapy |
| Protocol group | Experimental | 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. Receives: Other: Early and progressive mobilization program; Other: Respiratory therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status
Ability to perform daily living activities assessed by Barthel Index
Measured: At the time of discharge from the ICU, at least 4 days after admission.
Secondary outcomes (11)
Level of physical activity during the whole intensive care unit stay
Level of physical activity measured by an accelerometer
Measured: At the time of discharge from the ICU, at least 4 days after admission.
Pulmonary function
Pulmonary function assessed by a spirometer
Measured: 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
Measured: At the time of discharge from the ICU, at least 4 days after admission.
Peripheral muscle strength
Muscle strength assessed by hand grip dynamometer
Measured: 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
Measured: At the time of discharge from the ICU, at least 4 days after admission.
Muscle function and mobility
Test by Time up and Go
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: approximately 40 minutes after therapy, immediately after the end of the protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start1 Feb 2017
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Carolina Fu, PhD, Principal investigator, Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889146
- Sponsor's protocol ID
- deborass
- Status last verified
- Nov 2018
- First submitted
- 3 Mar 2016
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31967219Schujmann 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.
PubMed 29747662
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02889146
- Acronym / sponsor ID
- deborass
- Conditions
- Critical Illness, Muscle Weakness
- Keywords
- Intensive Care Units, Physical Therapy Specialty, Critical illness, Muscle weakness, Bed rest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 5 Sep 2016 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Conventional Physical Therapy, Other: Respiratory therapyConventional Physical Therapy: motor physical therapy delivered by the intensive care unit physical therapists, according to his own criteria, without following any protocol. Respiratory therapy. |
| Protocol group | Experimental | Other: Early and progressive mobilization program, Other: Respiratory therapyEarly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- transference from other hospital
- diagnosis of neurological disorders
- intensive care unit stay < 4 days
- contraindication to mobilization
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 |
|---|---|---|
| Conventional Physical TherapyControl 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 | Control group |
| Early and progressive mobilization programProtocol 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. | Other | Protocol group |
| Respiratory therapyRespiratory therapy according to the service routine. | Other | Control group, Protocol group |
Primary outcome
Functional status
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Ability to perform daily living activities assessed by Barthel Index
11 secondary outcomes
Level of physical activity during the whole intensive care unit stay
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Pulmonary function
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Maximum inspiratory pressure
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Peripheral muscle strength
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Electromyography muscle activity
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Muscle function and mobility
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Intensive care unit length of stay
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
Correlation between physiological variables and the level of physical activity
Time frame: At the time of discharge from the ICU, at least 4 days after admission.
ICU mobility Scale
Time frame: Through study completion, an average of 2 weeks
Long term follow up
Time frame: After three months and one year of discharge
Level of activity by Perceived Exertion
Time frame: approximately 40 minutes after therapy, immediately after the end of the protocol
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 29 Nov 2018.
- Derived from this study: PubMed 31967219Gomes 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.
- Derived from this study: PubMed 29747662Schujmann 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.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Illness
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
Respiratory Insufficiency, Wounds and Injuries
Not yet recruitingObservational study
Dynamic Inflammatory Changes and Nutritional Risk Scores in ICU Patients Aged 65 Years and Older
Critical Illness, Geriatric Patient
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.
Carolina Fu, PhD principal investigator
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy - Medical School of University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physical Therapy, Early and progressive mobilization program and Respiratory therapy in people with Critical Illness and Muscle Weakness, run by University of Sao Paulo General Hospital 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 11 inclusion and 4 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 29 Nov 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?
Functional status (time frame: At the time of discharge from the ICU, at least 4 days after admission.). 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 NCT02889146, which also lists 2 linked publications.
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 29 Nov 2018.