Critical IllnessETMNCT00999011
Dose of Early Therapeutic Mobility: Does Type or Frequency Matter?
A study testing once daily mobility activity and twice daily mobility activity in people with Critical Illness, run by Case Western Reserve University at 1 site in United States.
Trial summary
This study will examine the effects of once and twice daily activity performed with patients who are breathing with the aid of a machine in an intensive care unit. Activity can occur in bed. Activity can include transfer to a chair and even walking once the patient's condition allows safe, out-of-bed activity. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- once daily mobility activity and twice daily mobility activity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Mar 2013
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who require invasive mechanical ventilation for more than 24 continuous hours in the surgical (SICU) or medical ICU (MICU)
- a P:F ratio > 100
- FiO2 < 60% and PEEP less than 10 cmH20 at baseline
- resting vital signs of HR 50-110, mean arterial pressure (MAP) 60-110 mmHg, peripheral oxygenation saturation (SpO2) greater than 88%. Exclusion Criteria:
- There are no exclusions based on gender or minority status.
- Patients will be excluded if they have pre-existing or current neurological, muscular or orthopedic disorders that require inactivity or immobilization during acute care or experience paresis/paralysis that will not improve. Examples of exclusionary conditions include end-stage muscular dystrophy, myasthenia gravis, new quadriplegia, coma, increased intracranial pressure, unrepaired hip fracture and multiple lower extremity fractures.
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- Patients for high risk of death will also be excluded, using criteria established by Norton et al.: ICU admission following a hospital stay of >9 days in the past 12 months; age >80 in the presence of 2 or more life-threatening illnesses (e.g., end-stage renal disease, severe heart failure (HF); diagnosis of an active stage IV malignancy; status post cardiac arrest; and diagnosis of intracerebral hemorrhage requiring mechanical ventilation.[99].
- Subjects over 400 pounds can be excluded from mobilization based on the judgment of the bedside nurse or project manager; if the risk for staff or patient harm from moving a patient with excessive weight is considered likely, mobilization will not occur.
- Criteria for exclusion include inability to stand or walk for at least 10 minutes prior to admission; inability to shift weight in bed or assist with turning, inability of staff to access bariatric equipment such as an overhead trapeze, chair, or walker.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frances Payne Bolton School of Nursing Case Western Reserve University
Cleveland, Ohio, 44106
About this study
This study will examine the effects of once and twice daily activity performed with patients who are breathing with the aid of a machine in an intensive care unit. Activity can occur in bed. Activity can include transfer to a chair and even walking once the patient's condition allows safe, out-of-bed activity. The investigators hypothesize that early, progressive activity will reduce inflammatory molecules in the blood, promote muscle and physical health and help patients to recover more quickly from critical illness.
Read the detailed description
Early therapeutic mobility (ETM) activity has been recommended to facilitate recovery and improve outcomes for the survivors of critical illness who experience prolonged mechanical ventilation. The effective dose (i.e., type, frequency and duration) of ETM activity is not known and there are limited reports about the application and effects of ETM in mechanically ventilated intensive care unit (ICU) patients. Three inflammatory biomarkers, interleukin (IL)-6, IL-10 and C-reactive protein, are potentially altered by a single episode of ETM activity. Systemic markers of physical health (i.e., vital signs, delirium, muscle strength, ventilator associated pneumonia, and duration of mechanical ventilation) may also be positively influenced by ETM. The primary aim of this interdisciplinary study is to compare the immediate effects of frequency--single and twice daily episodes--of ETM activity and the effects of type--low and moderate intensity--of ETM activity on molecular biomarkers of inflammation and systemic markers of physical health in mechanically ventilated adults. This is an experimental design, using repeated measures; subjects will be randomized to receive either one or two episodes of ETM activity daily during week days while in the ICU. Type of activity will be determined by patient condition. The research questions are:
- a. What are the differences between the frequency (once versus twice daily) of ETM activities on inflammatory biomarkers: interleukin (IL)-6, IL-10 and C-reactive protein (CRP)? 1.b. What are the differences between the type (low or moderate) of ETM activities on inflammatory biomarkers: IL-6, IL-10 and CRP?
- a. What are the differences between frequency of ETM activities on systemic markers of physical health: vital signs, delirium, muscle strength, ventilator-associated pneumonia and duration of mechanical ventilation? 2.b. What are the differences between type of ETM activities on systemic markers of physical health: vital signs, delirium, muscle strength, ventilator-associated pneumonia and duration of mechanical ventilation?
Data will be collected for a maximum of 3 contiguous days in ICU patients who are mechanically ventilated for >48 hours, then weekly to examine short-term patient responses to ETM activities in this preliminary study. Daily episodes of activity will be provided by a study interventionist. Repeated measures MANCOVA and ANCOVA will be used to answer the research questions. This collaborative study evaluates a biobehavioral methodology within an interdisciplinary team consistent with the biobehavioral methods to improve outcome research (PA-07-008) and the mission of the National Institute of Nursing Research to improve treatments and health based on evidence.
- Conditions
- Critical Illness
- Being tested
- once daily mobility activity, twice daily mobility activity
- Keywords
- critical care, inflammatory biomarkers, cytokines, mechanical ventilation, activity, mobility therapy, More than 48 hours of mechanical ventilation
- Medical subject headings
- Critical Illness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
once daily mobility activityProcedure or surgery
in bed and out-of-bed activity including range of motion, chair sitting, sitting at edge of bed without weightbearing, standing, walking.
twice daily mobility activityProcedure or surgery
as with once daily. Goal is to progress intensity and duration of activity over time as patient condition improves for both arms
| Study group | Role | What they receive |
|---|---|---|
| One 20 minute period of activity daily | Active comparator | passive and/or active range of motion, chair sitting, sitting at edge of bed, standing and walking Receives: Procedure: once daily mobility activity |
| Two periods of 20 minute activity daily | Active comparator | passive and/or active range of motion, chair sitting, sitting at edge of bed, standing and walking Receives: Procedure: twice daily mobility activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in molecular biomarkers of inflammation day 1 of intervention
IL-6, IL-10, C-reactive protein.
Measured: 1 day
Change in molecular biomarkers of inflammation day 2 of intervention if patient still in ICU
IL-6, IL-10, C-reactive protein.
Measured: 1 day
Change in molecular biomarkers of inflammation day 3 of intervention if patient still in ICU
IL-6, IL-10, C-reactive protein.
Measured: 1 day
Vital Signs included RR, HR, and SBP. Change in Respiratory Rate day 1 of intervention.
Change is Respiratory rate (RR),measured in breaths per minute, during the intervention and comparing to baseline (rest) only.
Measured: Baseline = time during rest immediately preceding the intervention. Intervention = 30 min of activity
Change in Respiratory Rate day 2 of intervention if patient still in ICU. Heart Rate and Systolic Blood Pressure. Each vital sign is measured separately and not aggregated.
Breaths per minute as recorded on the bedside monitor Change defined as the difference between RR at rest and highest RR during the intervention.
Measured: Baseline RR = time during rest immediately preceding the intervention. Intervention RR = 30 min activity
Change in Respiratory Rate day3 of intervention if patient still in ICU.
Breaths per minute as recorded on the bedside monitor Change defined as the difference between RR at rest and RR duriing activity.
Measured: Baseline RR = time during rest immediately preceding the intervention. Intervention RR= during 30 min of activity
Vital Signs. Change in Heart Rate day 1 of intervention
Change in Heart rate (HR), measured in beats per minute, during the intervention only comparing to baseline. The bedside ICU monitor was used.
Measured: ring rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.
Change in Heart Rate day 2 of intervention if patient still in ICU
Change in Heart rate (HR), measured in beats per minute, during the intervention only comparing to baseline. The bedside ICU monitor was used.
Measured: Once daily or twice daily for up to 3 days of intervention. Baseline = time during rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.
Change in Heart Rate day 3 if patient still in ICU
Change in Heart rate (HR), measured in beats per minute, during the intervention only comparing to baseline. The bedside ICU monitor was used.
Measured: Once daily or twice daily for up to 3 days of intervention. Baseline = time during rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.
Vital Signs , Change in Systolic Blood Pressure day 1
Change in SBP, measured inmmHg, during the intervention only comparing to baseline. The bedside ICU monitor was used. The highest and lowest values were recorded for analysis. The largest change from baseline rest were used in analysis (Rest - Highest value obtained during intervention. This was done 3 times (once daily for up to 3 days) if randomized to once daily interventions or up to 6 times if randomized to twice daily intervention over 3 days.
Measured: Once daily or twice daily for up to 3 days of intervention. Baseline = time during rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.
Vital Signs. Change in Systolic Blood Pressure day 2 of intervention if patient still in ICU
Change in Systolic blood pressure (SBP), measured in millimeters of mercury (mmHg) during the intervention comparing to baseline. The bedisde ICU monitor was used if an arterial indwelling line was present. An automatic BP cuff (dynometer) was used at the start and every 5 minutes if an indwelling line was used. The highest and lowest values were recorded during the intervention.
Measured: Once daily or twice daily for up to 3 days on intervention. Baseline = time during rest immediately preceding the intervention Outcome = highest and lowest values during the mobility intervention.
Change in Systolic Blood Pressure Day 3 of intervention if patient still in ICU
Change in Systolic blood pressure (SBP), measured in millimeters of mercury (mmHg) during the intervention comparing to baseline. The bedisde ICU monitor was used if an arterial indwelling line was present. An automatic BP cuff (dynometer) was used at the start and every 5 minutes if an indwelling line was used. The highest and lowest values were recorded during the intervention.
Measured: Once daily or twice daily for up to 3 days on intervention. Baseline = time during rest immediately preceding the intervention Outcome = highest and lowest values during the mobility intervention.
The total number of days of Mechanical Ventilation while in the ICU
. This is a one-time value. This is the total number of days the patient received invasive mechanical ventilation as documented in the record.
Measured: Measured one time, at the discharge from the ICU
Muscle strength day 1
This was measured with hand grip using a dynometer and reported as dynes or kg of force.
Measured: Measured once after the intervention on day 1. Collected as many as 3 times if the patient received 3 days of intervention
Muscle strength day 2
This was measured with hand grip using a dynometer and reported as dynes or kg of force.
Measured: Measured once after the intervention. Collected as many as 3 times if the patient received 3 days of intervention
Muscle strength day 3
This was measured with hand grip using a dynometer and reported as dynes or kg of force.
Measured: Measured once after the intervention. Collected as many as 3 times if the patient received 3 days of intervention
Change in muscle strength
This was defined as the difference in dynes from Day 1 to Day 3, if the patient was in the ICU for 3 days, or the change from Day 1 to 2 if in the ICU for only 2 days
Measured: Collected once after the interention on days 1, 2, 3. The maximum potential change was defined as Day 1-Day 3 but Day 1 -Day was used for patients who were discharged from the ICU on Day 2 and had no data for Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionMar 2013
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 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), MetroHealth Medical Center
- Responsible party
- Principal investigator, Chris Winkelman, Case Western Reserve University
- Investigators
- Chris Winkelman, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999011
- Sponsor's protocol ID
- NR10781-01A1
- Other IDs
- 1R21NR010781-01A1
- Acronym
- ETM
- Status last verified
- Mar 2022
- First submitted
- 20 Oct 2009
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Winkelman C, Sattar A, Momotaz H, Johnson KD, Morris P, Rowbottom JR, Thornton JD, Feeney S, Levine A. Dose of Early Therapeutic Mobility: Does Frequency or Intensity Matter? Biol Res Nurs. 2018 Oct;20(5):522-530. doi: 10.1177/1099800418780492. Epub 2018 Jun 14.
PubMed 29902939
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose of Early Therapeutic Mobility: Does Type or Frequency Matter?
- ClinicalTrials.gov ID
- NCT00999011
- Acronym / sponsor ID
- ETM / NR10781-01A1
- Conditions
- Critical Illness
- Keywords
- critical care, inflammatory biomarkers, cytokines, mechanical ventilation, activity, mobility therapy, More than 48 hours of mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), MetroHealth Medical Center
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Oct 2009 (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.
This study will examine the effects of once and twice daily activity performed with patients who are breathing with the aid of a machine in an intensive care unit. Activity can occur in bed. Activity can include transfer to a chair and even walking once the patient's condition allows safe, out-of-bed activity. The investigators hypothesize that early, progressive activity will reduce inflammatory molecules in the blood, promote muscle and physical health and help patients to recover more quickly from critical illness.
Detailed description
Early therapeutic mobility (ETM) activity has been recommended to facilitate recovery and improve outcomes for the survivors of critical illness who experience prolonged mechanical ventilation. The effective dose (i.e., type, frequency and duration) of ETM activity is not known and there are limited reports about the application and effects of ETM in mechanically ventilated intensive care unit (ICU) patients. Three inflammatory biomarkers, interleukin (IL)-6, IL-10 and C-reactive protein, are potentially altered by a single episode of ETM activity. Systemic markers of physical health (i.e., vital signs, delirium, muscle strength, ventilator associated pneumonia, and duration of mechanical ventilation) may also be positively influenced by ETM. The primary aim of this interdisciplinary study is to compare the immediate effects of frequency--single and twice daily episodes--of ETM activity and the effects of type--low and moderate intensity--of ETM activity on molecular biomarkers of inflammation and systemic markers of physical health in mechanically ventilated adults. This is an experimental design, using repeated measures; subjects will be randomized to receive either one or two episodes of ETM activity daily during week days while in the ICU. Type of activity will be determined by patient condition. The research questions are:
- a. What are the differences between the frequency (once versus twice daily) of ETM activities on inflammatory biomarkers: interleukin (IL)-6, IL-10 and C-reactive protein (CRP)? 1.b. What are the differences between the type (low or moderate) of ETM activities on inflammatory biomarkers: IL-6, IL-10 and CRP?
- a. What are the differences between frequency of ETM activities on systemic markers of physical health: vital signs, delirium, muscle strength, ventilator-associated pneumonia and duration of mechanical ventilation? 2.b. What are the differences between type of ETM activities on systemic markers of physical health: vital signs, delirium, muscle strength, ventilator-associated pneumonia and duration of mechanical ventilation?
Data will be collected for a maximum of 3 contiguous days in ICU patients who are mechanically ventilated for >48 hours, then weekly to examine short-term patient responses to ETM activities in this preliminary study. Daily episodes of activity will be provided by a study interventionist. Repeated measures MANCOVA and ANCOVA will be used to answer the research questions. This collaborative study evaluates a biobehavioral methodology within an interdisciplinary team consistent with the biobehavioral methods to improve outcome research (PA-07-008) and the mission of the National Institute of Nursing Research to improve treatments and health based on evidence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One 20 minute period of activity daily | Active comparator | Procedure: once daily mobility activitypassive and/or active range of motion, chair sitting, sitting at edge of bed, standing and walking |
| Two periods of 20 minute activity daily | Active comparator | Procedure: twice daily mobility activitypassive and/or active range of motion, chair sitting, sitting at edge of bed, standing and walking |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients who require invasive mechanical ventilation for more than 24 continuous hours in the surgical (SICU) or medical ICU (MICU)
- a P:F ratio > 100
- FiO2 < 60% and PEEP less than 10 cmH20 at baseline
- resting vital signs of HR 50-110, mean arterial pressure (MAP) 60-110 mmHg, peripheral oxygenation saturation (SpO2) greater than 88%. Exclusion Criteria:
- There are no exclusions based on gender or minority status.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| once daily mobility activityin bed and out-of-bed activity including range of motion, chair sitting, sitting at edge of bed without weightbearing, standing, walking. | Procedure or surgery | One 20 minute period of activity daily |
| twice daily mobility activityas with once daily. Goal is to progress intensity and duration of activity over time as patient condition improves for both arms | Procedure or surgery | Two periods of 20 minute activity daily |
Primary outcome
Change in molecular biomarkers of inflammation day 1 of intervention
Time frame: 1 day
IL-6, IL-10, C-reactive protein.
Change in molecular biomarkers of inflammation day 2 of intervention if patient still in ICU
Time frame: 1 day
IL-6, IL-10, C-reactive protein.
Change in molecular biomarkers of inflammation day 3 of intervention if patient still in ICU
Time frame: 1 day
IL-6, IL-10, C-reactive protein.
Vital Signs included RR, HR, and SBP. Change in Respiratory Rate day 1 of intervention.
Time frame: Baseline = time during rest immediately preceding the intervention. Intervention = 30 min of activity
Change is Respiratory rate (RR),measured in breaths per minute, during the intervention and comparing to baseline (rest) only.
Change in Respiratory Rate day 2 of intervention if patient still in ICU. Heart Rate and Systolic Blood Pressure. Each vital sign is measured separately and not aggregated.
Time frame: Baseline RR = time during rest immediately preceding the intervention. Intervention RR = 30 min activity
Breaths per minute as recorded on the bedside monitor Change defined as the difference between RR at rest and highest RR during the intervention.
Change in Respiratory Rate day3 of intervention if patient still in ICU.
Time frame: Baseline RR = time during rest immediately preceding the intervention. Intervention RR= during 30 min of activity
Breaths per minute as recorded on the bedside monitor Change defined as the difference between RR at rest and RR duriing activity.
Vital Signs. Change in Heart Rate day 1 of intervention
Time frame: ring rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.
Change in Heart rate (HR), measured in beats per minute, during the intervention only comparing to baseline. The bedside ICU monitor was used.
Change in Heart Rate day 2 of intervention if patient still in ICU
Time frame: Once daily or twice daily for up to 3 days of intervention. Baseline = time during rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.
Change in Heart rate (HR), measured in beats per minute, during the intervention only comparing to baseline. The bedside ICU monitor was used.
Change in Heart Rate day 3 if patient still in ICU
Time frame: Once daily or twice daily for up to 3 days of intervention. Baseline = time during rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.
Change in Heart rate (HR), measured in beats per minute, during the intervention only comparing to baseline. The bedside ICU monitor was used.
Vital Signs , Change in Systolic Blood Pressure day 1
Time frame: Once daily or twice daily for up to 3 days of intervention. Baseline = time during rest immediately preceding the intervention. Outcome = highest and lowest values during the mobility intervention.
Change in SBP, measured inmmHg, during the intervention only comparing to baseline. The bedside ICU monitor was used. The highest and lowest values were recorded for analysis. The largest change from baseline rest were used in analysis (Rest - Highest value obtained during intervention. This was done 3 times (once daily for up to 3 days) if randomized to once daily interventions or up to 6 times if randomized to twice daily intervention over 3 days.
Vital Signs. Change in Systolic Blood Pressure day 2 of intervention if patient still in ICU
Time frame: Once daily or twice daily for up to 3 days on intervention. Baseline = time during rest immediately preceding the intervention Outcome = highest and lowest values during the mobility intervention.
Change in Systolic blood pressure (SBP), measured in millimeters of mercury (mmHg) during the intervention comparing to baseline. The bedisde ICU monitor was used if an arterial indwelling line was present. An automatic BP cuff (dynometer) was used at the start and every 5 minutes if an indwelling line was used. The highest and lowest values were recorded during the intervention.
Change in Systolic Blood Pressure Day 3 of intervention if patient still in ICU
Time frame: Once daily or twice daily for up to 3 days on intervention. Baseline = time during rest immediately preceding the intervention Outcome = highest and lowest values during the mobility intervention.
Change in Systolic blood pressure (SBP), measured in millimeters of mercury (mmHg) during the intervention comparing to baseline. The bedisde ICU monitor was used if an arterial indwelling line was present. An automatic BP cuff (dynometer) was used at the start and every 5 minutes if an indwelling line was used. The highest and lowest values were recorded during the intervention.
The total number of days of Mechanical Ventilation while in the ICU
Time frame: Measured one time, at the discharge from the ICU
. This is a one-time value. This is the total number of days the patient received invasive mechanical ventilation as documented in the record.
Muscle strength day 1
Time frame: Measured once after the intervention on day 1. Collected as many as 3 times if the patient received 3 days of intervention
This was measured with hand grip using a dynometer and reported as dynes or kg of force.
Muscle strength day 2
Time frame: Measured once after the intervention. Collected as many as 3 times if the patient received 3 days of intervention
This was measured with hand grip using a dynometer and reported as dynes or kg of force.
Muscle strength day 3
Time frame: Measured once after the intervention. Collected as many as 3 times if the patient received 3 days of intervention
This was measured with hand grip using a dynometer and reported as dynes or kg of force.
Change in muscle strength
Time frame: Collected once after the interention on days 1, 2, 3. The maximum potential change was defined as Day 1-Day 3 but Day 1 -Day was used for patients who were discharged from the ICU on Day 2 and had no data for Day 3
This was defined as the difference in dynes from Day 1 to Day 3, if the patient was in the ICU for 3 days, or the change from Day 1 to 2 if in the ICU for only 2 days
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 31 Mar 2022.
- Derived from this study: PubMed 29902939Winkelman C, Sattar A, Momotaz H, Johnson KD, Morris P, Rowbottom JR, Thornton JD, Feeney S, Levine A. Dose of Early Therapeutic Mobility: Does Frequency or Intensity Matter? Biol Res Nurs. 2018 Oct;20(5):522-530. doi: 10.1177/1099800418780492. Epub 2018 Jun 14.
- Individual participant dataSharing planned: No
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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.
Chris Winkelman, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing once daily mobility activity and twice daily mobility activity in people with Critical Illness, run by Case Western Reserve University at 1 site in United States.
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 9 inclusion and 0 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 31 Mar 2022. 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 United States. 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?
Change in molecular biomarkers of inflammation day 1 of intervention (time frame: 1 day). The study lists 17 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 NCT00999011, 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 31 Mar 2022.