Intensive Care Unit Acquired WeaknessTryCYCLENCT01885442
TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
A study testing In-bed leg cycle ergometry in people with Intensive Care Unit Acquired Weakness and Critical Care, run by McMaster University at 1 site in Canada.
Trial summary
Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very vulnerable to weakness and disability. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation
- What is being tested?
- In-bed leg cycle ergometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Jan 2015
- 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
- Adult patients ≥18 years old
- Invasively mechanically ventilated ≤4 days
- Expected additional 2 day ICU stay
- Ability to ambulate independently pre-hospital (with or without a gait aid)
Who cannot join
- Unable to follow simple commands at baseline
- Pregnancy
- Acute conditions impairing ability to walk or cycle (e.g., leg or foot fracture)
- Acute central condition or peripheral injury resulting in neuromuscular weakness (e.g., stroke, Guillain Barré syndrome)
- Primary generalized weakness of the central or peripheral nervous system (e.g., multiple sclerosis, myasthenia gravis, Parkinson's disease, amyotrophic lateral sclerosis)
- Temporary pacemaker wires
Show all 12Show fewer
- Expected hospital mortality> 90%
- Cycling equipment unable to fit patient's body dimensions (e.g., leg amputation or obesity)
- Specific surgical exclusion as stipulated by attending
- ->7 day ICU stay
- Physician declines
- Patient did not meet daily screening criteria to provide in-bed leg cycling during the first 4 days of mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare Intensive Care Unit
Hamilton, Ontario, L8N 4A6
About this study
Official title: TryCYCLE (Critical Care Cycling to Improve Lower Extremity Strength): A Prospective Pilot Study of the Safety and Feasibility of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very vulnerable to weakness and disability. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling employs special equipment that attaches to a patient's hospital bed, allowing them gentle leg exercise while in the ICU. The investigators will offer patients in-bed cycling while they are needing a breathing machine, to help them recover from weakness as fast as possible. Before doing a larger trial testing if in-bed cycling reduces disability, data on safety (Is it safe?) and feasibility (Can the investigators do it?) are needed.
Objectives: To study the safety and feasibility of in-bed leg cycling in critically ill patients who need breathing machines.
Read more
Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Specially trained physiotherapists will provide patients with 30 minutes of in-bed cycling each day while they are in the ICU.
Outcomes: The investigators will study (1) Safety: the heart rate and breathing patterns of patients doing in-bed cycling, while carefully monitoring for safety. (2) Feasibility: whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether the investigators can assess patients' strength in the ICU and at hospital discharge.
Relevance: As the Canadian population ages, the demand for breathing machines during acute illness will increase dramatically. Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot study is the first of several future larger studies about in-bed cycling in the ICU. This program of research will help patients needing life support to regain their strength and recover as fast as possible from critical illness.
- Conditions
- Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation, Respiratory Failure
- Being tested
- In-bed leg cycle ergometry
- Keywords
- mechanical ventilation, cycle ergometry, intensive care unit, rehabilitation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-bed leg cycle ergometryDevice
Also called RT300 Supine Cycle Ergometer (Restorative Therapies, Baltimore, MD)
Patients will receive 30 minutes of in-bed leg cycling in addition to routine physiotherapy, 6 days per week, for the duration of their ICU stay (to a maximum of 28 days).
| Study group | Role | What they receive |
|---|---|---|
| In-bed leg cycle ergometry | Experimental | Not described Receives: Device: In-bed leg cycle ergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of in-bed leg cycling research sessions terminated (composite outcome)
Research sessions will stop if the patient meets any of the following criteria:
- Sustained oxygen desaturation <88%, despite adjustments to FiO2
- Heart rate
- Low: 20 bpm less than lowest baseline value or 40 bpm (whichever is highest)
- High: 20 bpm more than highest baseline value or 140 bpm (whichever is lowest)
- Mean Arterial Pressure <55 or >110 mmHg
- Marked ventilator dyssynchrony not corrected by adjusting cycle off criteria
Safety events:
- Suspected new unstable / uncontrolled arrhythmia
- Concern for myocardial ischaemia
- Respiratory distress leading to symptoms of intolerable dyspnea
- Unplanned extubation Any of the following catheter or tube dislodgements
- Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter
- Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy
ICU physician, patient or proxy requests termination of session
Measured: From date of enrollment until date of ICU discharge, approximately 10 days on average
Secondary outcomes (6)
Number of adverse events: Intravascular catheter or tube dislodgement rate during in-bed cycling
Any of the following catheter or tube dislodgements:
- Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter
- Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy
Measured: From date of enrollment until date of ICU discharge, approximately 10 days on average
Daily research session delivery rate
We will assess our ability to deliver cycling during the ICU stay by comparing our daily delivery rate with that achieved in ICU rehabilitation randomized clinical trials (80%).
Measured: From date of enrollment until date of ICU discharge, approximately 10 days on average
Rate of outcome measure ascertainment in assessable patients at ICU awakening
We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates.
Measured: 5 days after study admission, on average
Rate of outcome measure ascertainment in assessable patients at ICU discharge
We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates.
Measured: 10 days after study admission, on average
Rate of outcome measure ascertainment in assessable patients at hospital discharge
We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates.
Measured: 15 days after study admission, on average
Consent rate feasibility
Consent rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Michelle E Kho, PT, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885442
- Sponsor's protocol ID
- TryCYCLE
- Acronym
- TryCYCLE
- Status last verified
- Apr 2016
- First submitted
- 21 Mar 2013
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kho ME, Molloy AJ, McCaughan M, et al. TryCYCLE: Preliminary results of early in-bed cycling with mechanically ventilated patients. Crit Care Med 2014;43.
Kho ME, Molloy AJ, Clarke FJ, Ajami D, McCaughan M, Obrovac K, Murphy C, Camposilvan L, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Zanni JM, Mourtzakis M, Piraino T, Cook DJ; Canadian Critical Care Trials Group. TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients. PLoS One. 2016 Dec 28;11(12):e0167561. doi: 10.1371/journal.pone.0167561. eCollection 2016.
PubMed 28030555
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TryCYCLE (Critical Care Cycling to Improve Lower Extremity Strength): A Prospective Pilot Study of the Safety and Feasibility of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT01885442
- Acronym / sponsor ID
- TryCYCLE / TryCYCLE
- Conditions
- Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation, Respiratory Failure
- Keywords
- mechanical ventilation, cycle ergometry, intensive care unit, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Jun 2013 (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.
Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very vulnerable to weakness and disability. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling employs special equipment that attaches to a patient's hospital bed, allowing them gentle leg exercise while in the ICU. The investigators will offer patients in-bed cycling while they are needing a breathing machine, to help them recover from weakness as fast as possible. Before doing a larger trial testing if in-bed cycling reduces disability, data on safety (Is it safe?) and feasibility (Can the investigators do it?) are needed.
Objectives: To study the safety and feasibility of in-bed leg cycling in critically ill patients who need breathing machines.
Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Specially trained physiotherapists will provide patients with 30 minutes of in-bed cycling each day while they are in the ICU.
Outcomes: The investigators will study (1) Safety: the heart rate and breathing patterns of patients doing in-bed cycling, while carefully monitoring for safety. (2) Feasibility: whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether the investigators can assess patients' strength in the ICU and at hospital discharge.
Relevance: As the Canadian population ages, the demand for breathing machines during acute illness will increase dramatically. Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot study is the first of several future larger studies about in-bed cycling in the ICU. This program of research will help patients needing life support to regain their strength and recover as fast as possible from critical illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-bed leg cycle ergometry | Experimental | Device: In-bed leg cycle ergometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients ≥18 years old
- Invasively mechanically ventilated ≤4 days
- Expected additional 2 day ICU stay
- Ability to ambulate independently pre-hospital (with or without a gait aid)
Key exclusion criteria (12 listed)
- Unable to follow simple commands at baseline
- Pregnancy
- Acute conditions impairing ability to walk or cycle (e.g., leg or foot fracture)
- Acute central condition or peripheral injury resulting in neuromuscular weakness (e.g., stroke, Guillain Barré syndrome)
- Primary generalized weakness of the central or peripheral nervous system (e.g., multiple sclerosis, myasthenia gravis, Parkinson's disease, amyotrophic lateral sclerosis)
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 |
|---|---|---|
| In-bed leg cycle ergometryAlso: RT300 Supine Cycle Ergometer (Restorative Therapies, Baltimore, MD)Patients will receive 30 minutes of in-bed leg cycling in addition to routine physiotherapy, 6 days per week, for the duration of their ICU stay (to a maximum of 28 days). | Device | In-bed leg cycle ergometry |
Primary outcome
Number of in-bed leg cycling research sessions terminated (composite outcome)
Time frame: From date of enrollment until date of ICU discharge, approximately 10 days on average
Research sessions will stop if the patient meets any of the following criteria: * Sustained oxygen desaturation <88%, despite adjustments to FiO2 * Heart rate * Low: 20 bpm less than lowest baseline value or 40 bpm (whichever is highest) * High: 20 bpm more than highest baseline value or 140 bpm (whichever is lowest) * Mean Arterial Pressure <55 or >110 mmHg * Marked ventilator dyssynchrony not corrected by adjusting cycle off criteria Safety events: * Suspected new unstable / uncontrolled arrhythmia * Concern for myocardial ischaemia * Respiratory distress leading to symptoms of intolerable dyspnea * Unplanned extubation Any of the following catheter or tube dislodgements * Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter * Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy ICU physician, patient or proxy requests termination of session
6 secondary outcomes
Number of adverse events: Intravascular catheter or tube dislodgement rate during in-bed cycling
Time frame: From date of enrollment until date of ICU discharge, approximately 10 days on average
Daily research session delivery rate
Time frame: From date of enrollment until date of ICU discharge, approximately 10 days on average
Rate of outcome measure ascertainment in assessable patients at ICU awakening
Time frame: 5 days after study admission, on average
Rate of outcome measure ascertainment in assessable patients at ICU discharge
Time frame: 10 days after study admission, on average
Rate of outcome measure ascertainment in assessable patients at hospital discharge
Time frame: 15 days after study admission, on average
Consent rate feasibility
Time frame: 1 year
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 6 Apr 2016.
- BackgroundKho ME, Molloy AJ, McCaughan M, et al. TryCYCLE: Preliminary results of early in-bed cycling with mechanically ventilated patients. Crit Care Med 2014;43.
- Derived from this study: PubMed 28030555Kho ME, Molloy AJ, Clarke FJ, Ajami D, McCaughan M, Obrovac K, Murphy C, Camposilvan L, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Zanni JM, Mourtzakis M, Piraino T, Cook DJ; Canadian Critical Care Trials Group. TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients. PLoS One. 2016 Dec 28;11(12):e0167561. doi: 10.1371/journal.pone.0167561. eCollection 2016.
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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.
Michelle E Kho, PT, PhD principal investigator
McMaster 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 In-bed leg cycle ergometry in people with Intensive Care Unit Acquired Weakness and Critical Care, run by McMaster University at 1 site in Canada.
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 12 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 6 Apr 2016. 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 Canada. 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?
Number of in-bed leg cycling research sessions terminated (composite outcome) (time frame: From date of enrollment until date of ICU discharge, approximately 10 days on average). 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 NCT01885442, which also lists 2 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 6 Apr 2016.