Critical IllnessPREDICTABLENCT03413189
The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness
An observational study of Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 3 sites in Australia.
Trial summary
Survival following a critical illness continues to improve with ongoing developments in medical management, however evidence shows that this patient group is at a high risk of suffering long term disability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Review of medical records, Assessment of physical and cognitive function and Interview of patients, carers and/or family members
- How many people
- 40 participants
- Where
- 3 sitesAustralia
- Study dates
- 9 Mar 2018to 31 Dec 2023
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients who were mechanically ventilated > 24 hours in an intensive care unit who have survived to hospital discharge.
Who may be able to join
- ICU patients who have been invasively mechanically ventilated for over 24 hours
Who cannot join
- Patients aged less than 18 years old
- A proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition (e.g. Traumatic Brain Injury, Subarachnoid Haemorrhage, stroke or hypoxic brain injury after cardiac arrest)
- Second or subsequent admission to ICU during a single hospital admission
- Death is deemed imminent and inevitable
- Participants who do no not speak English
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Monash Medical Centre
Clayton, Victoria, 3168
Dandenong Hospital
Dandenong, Victoria, 3175
Australian and New Zealand Intensive Care Research Centre
Melbourne, Victoria, 3004
About this study
Official title: PREDICTABLE: The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness
Survival following a critical illness continues to improve with ongoing developments in medical management, however evidence shows that this patient group is at a high risk of suffering long term disability. The objectives are to determine if there is a link between the amount of exercise performed in intensive care on the presence of delirium, long term cognition and disability whilst ensuring that patient reported outcomes correlate with actual measured results, and to obtain information on recovery from patients and/or relatives to determine themes.
Read the detailed description
Survival from a critical illness is increasing, however the long term effect on patient's quality of life and the ability for patients to return to pre-illness function is unfavourable. Exercise in the ICU has been proven to be safe and effective, with decreases in length of stay and improvements in physical and psychosocial function seen in multiple studies. At present, the investigators are unsure on the most effective way to exercise this patient group in relation to duration, type, intensity and frequency.
The investigators aim to link the presence of delirium during an ICU admission, disability-free survival and quality of life obtained from telephone follow-up six months following ICU discharge with the amount of exercise performed during their ICU stay to determine a relationship. Additionally, in a small group of participants, the investigators will measure cognitive and physical function to ensure that the patient reported data accurately reflects their true functional level, while allowing patients and/or relatives, next of kin or carers to provide information regarding their recovery through an interview process.
The measure of physical function and disability (via the WHODAS and Euro Qol Group Health Survey (EQ5D)) obtained during telephone interview of the 500 patients enrolled in the PREDICT study will be correlated with the amount of exercise they performed whilst in Intensive Care obtained from the medical records. The presence of delirium will also be obtained from the medical records and linked with the amount of exercise performed to determine if a link is present. A sub-set of this population (40) will be invited at the 3-month follow up phone call of the PREDICT study to have a physiotherapist visit them to assess their cognitive and physical function and interview them and/or their relatives, next of kin or carer to determine themes of the recovery process following critical illness.
- Conditions
- Critical Illness
- Being tested
- Review of medical records, Assessment of physical and cognitive function, Interview of patients, carers and/or family members
- Keywords
- Exercise, Dosage, Function
- 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.
Review of medical recordsOther
Medical records of patients will be reviewed to establish the median and highest level of functional achieved in Intensive Care (intensity) and the percentage of exercise sessions performed (frequency)
Assessment of physical and cognitive functionOther
This will be performed in person through the Function Independence Measure (FIM), grip strength, functional reach, 6-minute walk test (6MWT) and Montreal Cognitive Assessment (MoCA-Blind).
Interview of patients, carers and/or family membersOther
Questions will be asked to participants regarding their recovery from Intensive Care to establish themes
| Study group | Role | What they receive |
|---|---|---|
| PREDICT participants | This cohort is obtained from the PREDICT study enrolment (approx. 500) and a review of their medical records will be conducted Receives: Other: Review of medical records | |
| PREDITCABLE participants | This is a nested cohort of patients recruited into PREDICT (approx. 40) that consent for a physiotherapist home visit to assess their physical and cognitive function and perform and interview to obtain themes regarding recovery Receives: Other: Review of medical records; Other: Assessment of physical and cognitive function; Other: Interview of patients, carers and/or family members |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measure the effect of exercise dosage in critical care on physical function
To correlate the amount of exercise performed in ICU on objectively measured physical function at 6 months following ICU admission (via 6MWT and FIM).
Measured: 6 months after ICU admission
The measure the effect of exercise dosage in critical care on cognitive function
To correlate the amount of exercise performed in ICU on cognitive function (via MoCA Blind)
Measured: Up to 6 months following ICU admission
Secondary outcomes (4)
To correlate patient reported functional outcomes EQ5D with objectively measured outcomes
Compare patient reported disability score (EQ-5D) with a gold standard functional outcome measure (6MWT and FIM)
Measured: 6 months after ICU admission
To correlate patient reported functional outcomes WHODAS with objectively measured outcomes
Compare patient reported disability score (WHODAS) with a gold standard functional outcome measure (6MWT and FIM).
Measured: 6 months after ICU admission
Identify themes regarding recovery from critical illness from patient interviews
Compare qualitative data from patients and relatives/carers/next of kin to identify themes regarding the recovery process.
Measured: 6 months after ICU admission
To correlate patient reported cognitive outcomes with in person measured cognitive outcomes
Compare patient reported MoCA Blind scores with those of the same test measured in person
Measured: 6 months after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start9 Mar 2018
- Primary completion30 Dec 2020
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Monash Health, Monash University
- Responsible party
- Sponsor
- Investigators
- Carol Hodgson, A/Prof, Principal investigator, Australian and New Zealand intensive Care Reserch Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413189
- Sponsor's protocol ID
- ANZICRC/PREDICTABLE/001
- Acronym
- PREDICTABLE
- Status last verified
- Sep 2023
- First submitted
- 12 Nov 2017
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
PubMed 18511703Angus DC, Musthafa AA, Clermont G, Griffin MF, Linde-Zwirble WT, Dremsizov TT, Pinsky MR. Quality-adjusted survival in the first year after the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 May;163(6):1389-94. doi: 10.1164/ajrccm.163.6.2005123.
PubMed 11371406Thomas HC, Scully LJ, Lever AM, Yap I, Pignatelli M. A review of the efficacy of adenine arabinoside and lymphoblastoid interferon in the Royal Free Hospital studies of hepatitis B virus carrier treatment: identification of factors influencing response rates. Infection. 1987;15 Suppl 1:S26-31. doi: 10.1007/BF01650108.
PubMed 2439462Barnato AE, Albert SM, Angus DC, Lave JR, Degenholtz HB. Disability among elderly survivors of mechanical ventilation. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1037-42. doi: 10.1164/rccm.201002-0301OC. Epub 2010 Nov 5.
PubMed 21057004Berney SC, Harrold M, Webb SA, Seppelt I, Patman S, Thomas PJ, Denehy L. Intensive care unit mobility practices in Australia and New Zealand: a point prevalence study. Crit Care Resusc. 2013 Dec;15(4):260-5.
PubMed 24289506Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.
PubMed 16763220Cuthbertson BH, Elders A, Hall S, Taylor J, MacLennan G, Mackirdy F, Mackenzie SJ; Scottish Critical Care Trials Group; Scottish Intensive Care Society Audit Group. Mortality and quality of life in the five years after severe sepsis. Crit Care. 2013 Apr 16;17(2):R70. doi: 10.1186/cc12616.
PubMed 23587132Cuthbertson BH, Roughton S, Jenkinson D, Maclennan G, Vale L. Quality of life in the five years after intensive care: a cohort study. Crit Care. 2010;14(1):R6. doi: 10.1186/cc8848. Epub 2010 Jan 20.
PubMed 20089197Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. doi: 10.1007/s00134-006-0217-3. Epub 2006 Jun 17.
PubMed 16783553Dowrick AS, Gabbe BJ, Williamson OD, Wolfe R, Cameron PA. A comparison of self-reported and independently observed disability in an orthopedic trauma population. J Trauma. 2006 Dec;61(6):1447-52. doi: 10.1097/01.ta.0000242219.02901.d9.
PubMed 17159689Gabbe BJ, Cameron PA. Importance of functional and quality of life outcomes in trauma. Surgeon. 2013 Apr;11(2):114. doi: 10.1016/j.surge.2012.11.002. Epub 2012 Nov 27. No abstract available.
PubMed 23200459Hashem MD, Nallagangula A, Nalamalapu S, Nunna K, Nausran U, Robinson KA, Dinglas VD, Needham DM, Eakin MN. Patient outcomes after critical illness: a systematic review of qualitative studies following hospital discharge. Crit Care. 2016 Oct 26;20(1):345. doi: 10.1186/s13054-016-1516-x.
PubMed 27782830Herridge MS, Batt J, Hopkins RO. The pathophysiology of long-term neuromuscular and cognitive outcomes following critical illness. Crit Care Clin. 2008 Jan;24(1):179-99, x. doi: 10.1016/j.ccc.2007.11.002.
PubMed 18241785Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
PubMed 21470008Hodgson CL, Berney S, Harrold M, Saxena M, Bellomo R. Clinical review: early patient mobilization in the ICU. Crit Care. 2013 Feb 28;17(1):207. doi: 10.1186/cc11820.
PubMed 23672747
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICTABLE: The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness
- ClinicalTrials.gov ID
- NCT03413189
- Acronym / sponsor ID
- PREDICTABLE / ANZICRC/PREDICTABLE/001
- Conditions
- Critical Illness
- Keywords
- Exercise, Dosage, Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Monash Health, Monash University
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Jan 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.
Survival following a critical illness continues to improve with ongoing developments in medical management, however evidence shows that this patient group is at a high risk of suffering long term disability. The objectives are to determine if there is a link between the amount of exercise performed in intensive care on the presence of delirium, long term cognition and disability whilst ensuring that patient reported outcomes correlate with actual measured results, and to obtain information on recovery from patients and/or relatives to determine themes.
Detailed description
Survival from a critical illness is increasing, however the long term effect on patient's quality of life and the ability for patients to return to pre-illness function is unfavourable. Exercise in the ICU has been proven to be safe and effective, with decreases in length of stay and improvements in physical and psychosocial function seen in multiple studies. At present, the investigators are unsure on the most effective way to exercise this patient group in relation to duration, type, intensity and frequency.
The investigators aim to link the presence of delirium during an ICU admission, disability-free survival and quality of life obtained from telephone follow-up six months following ICU discharge with the amount of exercise performed during their ICU stay to determine a relationship. Additionally, in a small group of participants, the investigators will measure cognitive and physical function to ensure that the patient reported data accurately reflects their true functional level, while allowing patients and/or relatives, next of kin or carers to provide information regarding their recovery through an interview process.
The measure of physical function and disability (via the WHODAS and Euro Qol Group Health Survey (EQ5D)) obtained during telephone interview of the 500 patients enrolled in the PREDICT study will be correlated with the amount of exercise they performed whilst in Intensive Care obtained from the medical records. The presence of delirium will also be obtained from the medical records and linked with the amount of exercise performed to determine if a link is present. A sub-set of this population (40) will be invited at the 3-month follow up phone call of the PREDICT study to have a physiotherapist visit them to assess their cognitive and physical function and interview them and/or their relatives, next of kin or carer to determine themes of the recovery process following critical illness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREDICT participants | – | Other: Review of medical recordsThis cohort is obtained from the PREDICT study enrolment (approx. 500) and a review of their medical records will be conducted |
| PREDITCABLE participants | – | Other: Review of medical records, Other: Assessment of physical and cognitive function, Other: Interview of patients, carers and/or family membersThis is a nested cohort of patients recruited into PREDICT (approx. 40) that consent for a physiotherapist home visit to assess their physical and cognitive function and perform and interview to obtain themes regarding recovery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients who were mechanically ventilated > 24 hours in an intensive care unit who have survived to hospital discharge.
Key inclusion criteria (1 listed)
- ICU patients who have been invasively mechanically ventilated for over 24 hours
Key exclusion criteria (5 listed)
- Patients aged less than 18 years old
- A proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition (e.g. Traumatic Brain Injury, Subarachnoid Haemorrhage, stroke or hypoxic brain injury after cardiac arrest)
- Second or subsequent admission to ICU during a single hospital admission
- Death is deemed imminent and inevitable
- Participants who do no not speak English
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 |
|---|---|---|
| Review of medical recordsMedical records of patients will be reviewed to establish the median and highest level of functional achieved in Intensive Care (intensity) and the percentage of exercise sessions performed (frequency) | Other | PREDICT participants, PREDITCABLE participants |
| Assessment of physical and cognitive functionThis will be performed in person through the Function Independence Measure (FIM), grip strength, functional reach, 6-minute walk test (6MWT) and Montreal Cognitive Assessment (MoCA-Blind). | Other | PREDITCABLE participants |
| Interview of patients, carers and/or family membersQuestions will be asked to participants regarding their recovery from Intensive Care to establish themes | Other | PREDITCABLE participants |
Primary outcome
The measure the effect of exercise dosage in critical care on physical function
Time frame: 6 months after ICU admission
To correlate the amount of exercise performed in ICU on objectively measured physical function at 6 months following ICU admission (via 6MWT and FIM).
The measure the effect of exercise dosage in critical care on cognitive function
Time frame: Up to 6 months following ICU admission
To correlate the amount of exercise performed in ICU on cognitive function (via MoCA Blind)
4 secondary outcomes
To correlate patient reported functional outcomes EQ5D with objectively measured outcomes
Time frame: 6 months after ICU admission
To correlate patient reported functional outcomes WHODAS with objectively measured outcomes
Time frame: 6 months after ICU admission
Identify themes regarding recovery from critical illness from patient interviews
Time frame: 6 months after ICU admission
To correlate patient reported cognitive outcomes with in person measured cognitive outcomes
Time frame: 6 months after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Background: PubMed 18511703Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.
- Background: PubMed 11371406Angus DC, Musthafa AA, Clermont G, Griffin MF, Linde-Zwirble WT, Dremsizov TT, Pinsky MR. Quality-adjusted survival in the first year after the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2001 May;163(6):1389-94. doi: 10.1164/ajrccm.163.6.2005123.
- Background: PubMed 2439462Thomas HC, Scully LJ, Lever AM, Yap I, Pignatelli M. A review of the efficacy of adenine arabinoside and lymphoblastoid interferon in the Royal Free Hospital studies of hepatitis B virus carrier treatment: identification of factors influencing response rates. Infection. 1987;15 Suppl 1:S26-31. doi: 10.1007/BF01650108.
- Background: PubMed 21057004Barnato AE, Albert SM, Angus DC, Lave JR, Degenholtz HB. Disability among elderly survivors of mechanical ventilation. Am J Respir Crit Care Med. 2011 Apr 15;183(8):1037-42. doi: 10.1164/rccm.201002-0301OC. Epub 2010 Nov 5.
- Background: PubMed 24289506Berney SC, Harrold M, Webb SA, Seppelt I, Patman S, Thomas PJ, Denehy L. Intensive care unit mobility practices in Australia and New Zealand: a point prevalence study. Crit Care Resusc. 2013 Dec;15(4):260-5.
- Background: PubMed 16763220Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.
- Background: PubMed 23587132Cuthbertson BH, Elders A, Hall S, Taylor J, MacLennan G, Mackirdy F, Mackenzie SJ; Scottish Critical Care Trials Group; Scottish Intensive Care Society Audit Group. Mortality and quality of life in the five years after severe sepsis. Crit Care. 2013 Apr 16;17(2):R70. doi: 10.1186/cc12616.
- Background: PubMed 20089197Cuthbertson BH, Roughton S, Jenkinson D, Maclennan G, Vale L. Quality of life in the five years after intensive care: a cohort study. Crit Care. 2010;14(1):R6. doi: 10.1186/cc8848. Epub 2010 Jan 20.
- Background: PubMed 16783553Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. doi: 10.1007/s00134-006-0217-3. Epub 2006 Jun 17.
- Background: PubMed 17159689Dowrick AS, Gabbe BJ, Williamson OD, Wolfe R, Cameron PA. A comparison of self-reported and independently observed disability in an orthopedic trauma population. J Trauma. 2006 Dec;61(6):1447-52. doi: 10.1097/01.ta.0000242219.02901.d9.
- Background: PubMed 23200459Gabbe BJ, Cameron PA. Importance of functional and quality of life outcomes in trauma. Surgeon. 2013 Apr;11(2):114. doi: 10.1016/j.surge.2012.11.002. Epub 2012 Nov 27. No abstract available.
- Background: PubMed 27782830Hashem MD, Nallagangula A, Nalamalapu S, Nunna K, Nausran U, Robinson KA, Dinglas VD, Needham DM, Eakin MN. Patient outcomes after critical illness: a systematic review of qualitative studies following hospital discharge. Crit Care. 2016 Oct 26;20(1):345. doi: 10.1186/s13054-016-1516-x.
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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.
Carol Hodgson, A/Prof principal investigator
Australian and New Zealand intensive Care Reserch Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Australian and New Zealand Intensive Care Research Centre at 3 sites in Australia.
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 1 inclusion and 5 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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?
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?
The measure the effect of exercise dosage in critical care on physical function (time frame: 6 months after ICU admission). 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 NCT03413189, which also lists 40 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 15 Sep 2023; AzTrials last refreshed its copy on 29 Oct 2026.