Critical IllnessNCT00695383
Early Exercise Training in Critically Ill Patients
A study testing Bedside cycle exercise therapy and Standard physiotherapy program in people with Critical Illness and Intensive Care, run by KU Leuven at 1 site in Belgium.
Trial summary
This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Intensive Care, Muscle Weakness
- What is being tested?
- Bedside cycle exercise therapy and Standard physiotherapy program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2005to Feb 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ICU stay > 5 days
- Expected prolonged stay of at least 7 more days
- Cardiorespiratory status that allows at least passive exercise therapy
Who cannot join
- Persistent or progressive neurological or (neuro)muscular disease
- Coagulation disorders (INR > 1.5, [BP] < 50000/mm³)
- Intracranial pressure > 20 mmHg
- Psychiatric disorders or severe confusion
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Rehabilitation Sciences, University Hospitals KULeuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery
This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.
Read the detailed description
Inactivity during prolonged bed rest leads to muscle dysfunction. Muscle function decreases even faster in ICU patients due to inflammation, pharmacological agents (corticosteroids, muscle relaxants, neuromuscular blockers, antibiotics), and the presence of neuromuscular syndromes, associated with critical illness. A recent recommendation document advices to start early with active and passive exercise in critically ill patients. However, no evidence is available concerning the feasibility of an early muscle training intervention in the acute ICU phase when patients are still under sedation. A rather new method to train bed-bound patients is the use of a bedside cycle ergometer. This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.
- Conditions
- Critical Illness, Intensive Care, Muscle Weakness, Deconditioning
- Being tested
- Bedside cycle exercise therapy, Standard physiotherapy program
- Keywords
- Exercise therapy, Physiotherapy, Critical illness, Intensive care, Muscle weakness, Mechanical ventilation
- 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.
Bedside cycle exercise therapyBehavioural
Also called exercise therapy, exercise training, exercise, cycle training
A 20-minute cycling exercise session is performed 5 days a week using a bedside cycle ergometer. Patients can cycle passively and actively against increasing resistance. Besides this, patients receive the standard physiotherapy program as in arm 2
Standard physiotherapy programBehavioural
Also called Usual physiotherapy, Routine physiotherapy, Mobilization
The standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Bedside cycle exercise therapy |
| 2 | Active comparator | Not described Receives: Behavioral: Standard physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
six-minute walking distance
Measured: hospital discharge
Secondary outcomes (2)
quadriceps force
Measured: ICU discharge and hospital discharge
functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)
Measured: ICU discharge and hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startDec 2005
- Primary completionFeb 2007
- Study completionFeb 2007
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Investigators
- Rik Gosselink, PT, phD, Study director, Department of Rehabilitation Sciences, University Hospitals KULeuvenChris Burtin, PT, MSc, Principal investigator, Department of Rehabilitation Sciences, University Hospitals KULeuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695383
- Sponsor's protocol ID
- G 0523.06
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2008
- Last updated
- 11 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Exercise in Critically Ill Patients Enhances Short-Term Functional Recovery
- ClinicalTrials.gov ID
- NCT00695383
- Acronym / sponsor ID
- G 0523.06
- Conditions
- Critical Illness, Intensive Care, Muscle Weakness, Deconditioning
- Keywords
- Exercise therapy, Physiotherapy, Critical illness, Intensive care, Muscle weakness, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- Dec 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 11 Jun 2008 (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 randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.
Detailed description
Inactivity during prolonged bed rest leads to muscle dysfunction. Muscle function decreases even faster in ICU patients due to inflammation, pharmacological agents (corticosteroids, muscle relaxants, neuromuscular blockers, antibiotics), and the presence of neuromuscular syndromes, associated with critical illness. A recent recommendation document advices to start early with active and passive exercise in critically ill patients. However, no evidence is available concerning the feasibility of an early muscle training intervention in the acute ICU phase when patients are still under sedation. A rather new method to train bed-bound patients is the use of a bedside cycle ergometer. This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Bedside cycle exercise therapy |
| 2 | Active comparator | Behavioral: Standard physiotherapy program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ICU stay > 5 days
- Expected prolonged stay of at least 7 more days
- Cardiorespiratory status that allows at least passive exercise therapy
Key exclusion criteria (4 listed)
- Persistent or progressive neurological or (neuro)muscular disease
- Coagulation disorders (INR > 1.5, [BP] < 50000/mm³)
- Intracranial pressure > 20 mmHg
- Psychiatric disorders or severe confusion
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 |
|---|---|---|
| Bedside cycle exercise therapyAlso: exercise therapy, exercise training, exercise, cycle trainingA 20-minute cycling exercise session is performed 5 days a week using a bedside cycle ergometer. Patients can cycle passively and actively against increasing resistance. Besides this, patients receive the standard physiotherapy program as in arm 2 | Behavioural | 1 |
| Standard physiotherapy programAlso: Usual physiotherapy, Routine physiotherapy, MobilizationThe standard physiotherapy program consists of daily chest physiotherapy and a mobilization session on 5 days per week. | Behavioural | 2 |
Primary outcome
six-minute walking distance
Time frame: hospital discharge
2 secondary outcomes
quadriceps force
Time frame: ICU discharge and hospital discharge
functional status (Berg Balance Scale, Functional Ambulation Categories, SF-36 Physical Function-item)
Time frame: ICU discharge and hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2008.
Related trials for Critical Illness
Not yet recruitingObservational study
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
Carbapenem-Resistant Acinetobacter Baumannii Infection
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
RecruitingObservational study
Detection and Characterization of Lower Respiratory Infections in Critically Ill Patients
Severe Pneumonia
Active, not recruitingObservational study
Adverse Events During Physical Therapy in Neurocritical ICU Patients
Critical Illness, Brain Injury
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.
Rik Gosselink, PT, phD study director
Department of Rehabilitation Sciences, University Hospitals KULeuven
Chris Burtin, PT, MSc principal investigator
Department of Rehabilitation Sciences, University Hospitals KULeuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedside cycle exercise therapy and Standard physiotherapy program in people with Critical Illness and Intensive Care, run by KU Leuven at 1 site in Belgium.
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 3 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 11 Jun 2008. 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 Belgium. 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?
six-minute walking distance (time frame: hospital discharge). 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 11 Jun 2008.