Critical IllnessNCT02408250
Tolerance of Early Exercise in Intensive Care Unit
An observational study of Critical Illness, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Exercise program
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to 31 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critical care unit patients
Who may be able to join
- Men and women
- Over 18 years old
- Hospitalized in intensive care unit
- Patients whose clinical condition allows initiating an early exercise program from critical care physician inclusion
Who cannot join
- Less than 18 years old or disabled adult
- Head or spinal severe trauma
- Severe trauma of the lower limbs or pelvis
- Musculoskeletal and neurological conditions which do not permit to realise the exercise program
- Patient for whom the reason for hospitalization does not justify early physical therapy
Trial locations and contacts
1 site in 1 country.
About this study
Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.
Read the detailed description
Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.
- Conditions
- Critical Illness
- Being tested
- Exercise program
- Keywords
- algorithm, critical illness, early exercise, feasibility, intensive care unit, physical therapy
- 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.
Exercise programProcedure or surgery
Exercise program in intensive care unit established from a decisional algorithm and applied to the critical care unit patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Score difference on a discomfort visual analogic scale between before and after program completion
Measured: at day 1
Secondary outcomes (4)
Functional capacity (PFIT: Physical Function ICU Test score)
Measured: at day 1
length of stay on intensive care unit
Measured: at day 1
mortality in ICU
Measured: at day 1
Unit of discharge (specialty of the unit)
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408250
- Sponsor's protocol ID
- CHU-0226
- Status last verified
- Feb 2019
- First submitted
- 16 Mar 2015
- Last updated
- 20 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Early Exercise in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02408250
- Acronym / sponsor ID
- CHU-0226
- Conditions
- Critical Illness
- Keywords
- algorithm, critical illness, early exercise, feasibility, intensive care unit, physical therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 3 Apr 2015 (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.
Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.
Detailed description
Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critical care unit patients
Key inclusion criteria (4 listed)
- Men and women
- Over 18 years old
- Hospitalized in intensive care unit
- Patients whose clinical condition allows initiating an early exercise program from critical care physician inclusion
Key exclusion criteria (5 listed)
- Less than 18 years old or disabled adult
- Head or spinal severe trauma
- Severe trauma of the lower limbs or pelvis
- Musculoskeletal and neurological conditions which do not permit to realise the exercise program
- Patient for whom the reason for hospitalization does not justify early physical therapy
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 |
|---|---|---|
| Exercise programExercise program in intensive care unit established from a decisional algorithm and applied to the critical care unit patients | Procedure or surgery | – |
Primary outcome
Score difference on a discomfort visual analogic scale between before and after program completion
Time frame: at day 1
4 secondary outcomes
Functional capacity (PFIT: Physical Function ICU Test score)
Time frame: at day 1
length of stay on intensive care unit
Time frame: at day 1
mortality in ICU
Time frame: at day 1
Unit of discharge (specialty of the unit)
Time frame: at day 1
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 20 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 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: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Score difference on a discomfort visual analogic scale between before and after program completion (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.