WeaknessNCT02478411
Early Cycloergometric Physiotherapy in Critically Ill Patients With Invasive Mechanical Ventilation
A study testing Cycle ergometer physiotherapy and Conventional physiotherapy in people with Weakness, run by Hospital Son Llatzer at 1 site in Spain.
Trial summary
Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weakness
- What is being tested?
- Cycle ergometer physiotherapy and Conventional physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Jun 2021
- 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
- Criteria of functional independence before hospital admission (Barthel scale > 70 points).
- Invasive mechanical ventilation < 72 hours.
- Signed informed consent.
Who cannot join
- Neuromuscular disease (peripheric or central neurologic disorder).
- Presumed fatal evolution in 48 hours.
- Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism).
- Admission due to cardiac arrest.
- Pregnancy.
- Thrombopenia less than 50.000.
Show all 9Show fewer
- Severe agitation.
- Hemodynamic instability with noradrenaline requirements greater than 1 mcg/kg/min.
- Fraction of inspired Oxygen (FiO2) requirements greater that 0.55 and respiratory rate greater than 30 bpm.
Trial locations and contacts
1 site in 1 country.
Catalina Morey, Phyt contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Son llàtzer
Palma de Mallorca, Balearic Islands, 07198
Gemma Rialp, M.D., 00 34 871202133, grialp@gmail.com
Catalina Morey, Phty
About this study
Official title: Functional and Motor Effects of an Early Cycloergometric Physiotherapy Program in Critically Ill Patients With Invasive Mechanical Ventilation. A Randomized Controlled Trial
Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy.
Read the detailed description
Cycloergometric treatment is described to improve the functional and motor status of critically ill subjects. However, there are few studies comparing cycloergometric physiotherapy and conventional physiotherapy in intensive care subjects under mechanical ventilation. The most relevant of these studies conducted by Burtin et al showed beneficial effects of cycloergometric treatment. However, the duration of the physiotherapy sessions in this study differed between groups as cycloergometric group received a double daily dose of treatment. It is known that the intensity of physiotherapy also affects the functional and motor status.
For this reason, the investigators designed a randomized controlled study with early cycloergometric or conventional treatment, with the same intensity between groups to analyze objective functional and motor endpoints.
- Conditions
- Weakness
- Being tested
- Cycle ergometer physiotherapy, Conventional physiotherapy
- Keywords
- muscle weakness, rehabilitation, intensive care, mechanical ventilation, cyclo ergometer, physiotherapy
- Medical subject headings
- Asthenia, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle ergometer physiotherapyProcedure or surgery
Also called MOTOmed ® Letto 2
15 minutes of cyclo ergometer physiotherapy with MOTOmed ® Letto 2 device with passive, motor-assisted and active-resisted exercise of the lower and upper extremity, and 15 minutes of conventional physiotherapy
Conventional physiotherapyProcedure or surgery
30 minutes of conventional physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cycle ergometer physiotherapy | Experimental | 15 minutes of cycle ergometer physiotherapy plus 15 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit Receives: Procedure: Cycle ergometer physiotherapy |
| Conventional physiotherapy | Active comparator | 30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit Receives: Procedure: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking test distance at six minutes
Measured: At hospital discharge, with an expected average of 4 weeks after hospital admission
Short Form-36 Health Survey (SF-36), physical functioning section
Measured: At 28 days after hospital discharge, that is an expected average of 8 weeks
Basic activities of daily living score (BADL)
Measured: At 28 days after hospital discharge, that is an expected average of 8 weeks
Secondary outcomes (7)
Lung Functional Testing
Measured: At the end of hospital stay, with an expected average of 5 weeks
Presence of intensive care acquired paresis (Medical Research Council score < 48 points)
Measured: During ICU admission and ICU discharge, with an expected average of 2 weeks
ICU mobilization scale
Measured: During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge
Isometric quadriceps force (N/kg)
Quadriceps strength will be measured with a handheld dynamometer with patients in supine position and 30º of knee flexion.
Measured: During ICU admission, with an expected average of 2 weeks
Walking test distance at six minutes
Measured: At 28 days and at 6 months after hospital discharge, that is up to 1 year
Short Form-36 Health Survey (SF-36), physical functioning section
Measured: At 7 days and at 6 months after hospital discharge, that is up to 1 year
Basic activities of daily living score (BADL)
Measured: At 7 days and at 6 months after hospital discharge, that is up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for WeaknessStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Son Llatzer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gemma Rialp, Hospital Son Llatzer
- Investigators
- Gemma Rialp, M.D., Principal investigator, IDISPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478411
- Sponsor's protocol ID
- CYCLE-ICU-001
- Status last verified
- Aug 2019
- First submitted
- 14 Jun 2015
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
PubMed 12472328TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.
PubMed 25715872Schweickert WD, Kress JP. Implementing early mobilization interventions in mechanically ventilated patients in the ICU. Chest. 2011 Dec;140(6):1612-1617. doi: 10.1378/chest.10-2829.
PubMed 22147819Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
PubMed 19446324Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.
PubMed 20046132Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
PubMed 19623052Bourdin G, Barbier J, Burle JF, Durante G, Passant S, Vincent B, Badet M, Bayle F, Richard JC, Guerin C. The feasibility of early physical activity in intensive care unit patients: a prospective observational one-center study. Respir Care. 2010 Apr;55(4):400-7.
PubMed 20406506
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Motor Effects of an Early Cycloergometric Physiotherapy Program in Critically Ill Patients With Invasive Mechanical Ventilation. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02478411
- Acronym / sponsor ID
- CYCLE-ICU-001
- Conditions
- Weakness
- Keywords
- muscle weakness, rehabilitation, intensive care, mechanical ventilation, cyclo ergometer, physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Hospital Son LlatzerUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 23 Jun 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.
Study designed to evaluate the functional and motor effects in critically ill subjects at ICU and hospital discharge with the incorporation of a mobilization program of cycloergometric physiotherapy sessions compared with conventional physiotherapy.
Detailed description
Cycloergometric treatment is described to improve the functional and motor status of critically ill subjects. However, there are few studies comparing cycloergometric physiotherapy and conventional physiotherapy in intensive care subjects under mechanical ventilation. The most relevant of these studies conducted by Burtin et al showed beneficial effects of cycloergometric treatment. However, the duration of the physiotherapy sessions in this study differed between groups as cycloergometric group received a double daily dose of treatment. It is known that the intensity of physiotherapy also affects the functional and motor status.
For this reason, the investigators designed a randomized controlled study with early cycloergometric or conventional treatment, with the same intensity between groups to analyze objective functional and motor endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycle ergometer physiotherapy | Experimental | Procedure: Cycle ergometer physiotherapy15 minutes of cycle ergometer physiotherapy plus 15 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit |
| Conventional physiotherapy | Active comparator | Procedure: Conventional physiotherapy30 minutes of conventional physiotherapy, once daily, five days a week, as long as patients remain in the intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Criteria of functional independence before hospital admission (Barthel scale > 70 points).
- Invasive mechanical ventilation < 72 hours.
- Signed informed consent.
Key exclusion criteria (9 listed)
- Neuromuscular disease (peripheric or central neurologic disorder).
- Presumed fatal evolution in 48 hours.
- Conditions that impede pedaling movement (leg, pelvis or lumbar spinal surgery or traumatism).
- Admission due to cardiac arrest.
- Pregnancy.
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 |
|---|---|---|
| Cycle ergometer physiotherapyAlso: MOTOmed ® Letto 215 minutes of cyclo ergometer physiotherapy with MOTOmed ® Letto 2 device with passive, motor-assisted and active-resisted exercise of the lower and upper extremity, and 15 minutes of conventional physiotherapy | Procedure or surgery | Cycle ergometer physiotherapy |
| Conventional physiotherapy30 minutes of conventional physiotherapy | Procedure or surgery | Conventional physiotherapy |
Primary outcome
Walking test distance at six minutes
Time frame: At hospital discharge, with an expected average of 4 weeks after hospital admission
Short Form-36 Health Survey (SF-36), physical functioning section
Time frame: At 28 days after hospital discharge, that is an expected average of 8 weeks
Basic activities of daily living score (BADL)
Time frame: At 28 days after hospital discharge, that is an expected average of 8 weeks
7 secondary outcomes
Lung Functional Testing
Time frame: At the end of hospital stay, with an expected average of 5 weeks
Presence of intensive care acquired paresis (Medical Research Council score < 48 points)
Time frame: During ICU admission and ICU discharge, with an expected average of 2 weeks
ICU mobilization scale
Time frame: During hospital stay, as expected average of 4 weeks, and at 28 days and at 6 months after discharge
Isometric quadriceps force (N/kg)
Time frame: During ICU admission, with an expected average of 2 weeks
Walking test distance at six minutes
Time frame: At 28 days and at 6 months after hospital discharge, that is up to 1 year
Short Form-36 Health Survey (SF-36), physical functioning section
Time frame: At 7 days and at 6 months after hospital discharge, that is up to 1 year
Basic activities of daily living score (BADL)
Time frame: At 7 days and at 6 months after hospital discharge, that is up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Results publication: PubMed 12472328De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.
- Results publication: PubMed 25715872TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.
- Results publication: PubMed 22147819Schweickert WD, Kress JP. Implementing early mobilization interventions in mechanically ventilated patients in the ICU. Chest. 2011 Dec;140(6):1612-1617. doi: 10.1378/chest.10-2829.
- Results publication: PubMed 19446324Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
- Results publication: PubMed 20046132Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.
- Results publication: PubMed 19623052Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
- Results publication: PubMed 20406506Bourdin G, Barbier J, Burle JF, Durante G, Passant S, Vincent B, Badet M, Bayle F, Richard JC, Guerin C. The feasibility of early physical activity in intensive care unit patients: a prospective observational one-center study. Respir Care. 2010 Apr;55(4):400-7.
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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.
Catalina Morey, Phyt contact
Gemma Rialp, M.D. principal investigator
IDISPA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycle ergometer physiotherapy and Conventional physiotherapy in people with Weakness, run by Hospital Son Llatzer at 1 site in Spain.
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 9 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 8 Aug 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 Spain. 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?
Contact Gemma Rialp, M.D. (00 34 871202133, grialp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking test distance at six minutes (time frame: At hospital discharge, with an expected average of 4 weeks after hospital admission). The study lists 3 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 NCT02478411, which also lists 7 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 8 Aug 2019.