Intensive Care Unit Acquired WeaknessPhase 2CYCLE PilotNCT02377830
CYCLE Pilot Randomized Trial
A Phase 2 study testing In-bed cycle ergometer (Restorative Therapies RT300 Supine) and Routine physiotherapy in people with Intensive Care Unit Acquired Weakness and Critical Care, run by McMaster University at 9 sites in 3 countries.
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 weak and disabled. 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 cycle ergometer (Restorative Therapies RT300 Supine) and Routine physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Mar 2015to Dec 2018
- Phase
- Phase 2
- 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
- Adults admitted to a medical-surgical ICU within the 1st 4 days of mechanical ventilation (MV) and 1st 7 days of ICU, and
- could ambulate independently before hospital admission.
Who cannot join
- Acute condition impairing patients' ability to cycle (e.g., leg fracture),
- proven or suspected neuromuscular weakness affecting the legs (e.g., stroke or Guillain-Barré syndrome),
- unable to follow commands in English pre-ICU,
- temporary pacemaker,
- expected hospital mortality >90%,
- unable to fit the bike, palliative goals of care, or persistent therapy exemptions in the 1st 4 days of MV (e.g., cardiorespiratory instability, active major bleeding)
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Canada7 sites
St. Joseph's Healthcare Intensive Care Unit
Hamilton, Ontario, L8N 4A6
Hamilton Health Sciences General ICU
Hamilton, Ontario
Hamilton Health Sciences Juravinski ICU
Hamilton, Ontario
London Health Sciences
London, Ontario
Ottawa General Hospital
Ottawa, Ontario
St. Michael's Hospital
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy 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 weak and disabled. 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 involves use of special equipment that attaches to a patient's hospital bed, allowing them gentle exercise while in the ICU.
Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed cycling each day they are in the ICU or routine physiotherapy, both delivered by specially trained physiotherapists.
Read more
Outcomes: Feasibility: The investigators will study 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 investigators can systematically assess patients' strength.
Relevance: Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized study is the second of several future larger studies about in-bed cycling in the ICU.
Our pilot work includes CYCLE Pilot and CYCLE Vanguard. CYCLE Pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. CYCLE Vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. CYCLE Vanguard patients will be analyzed in the main CYCLE RCT (NCT03471247).
- Conditions
- Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation, Respiratory Failure
- Being tested
- In-bed cycle ergometer (Restorative Therapies RT300 Supine), Routine physiotherapy
- 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 cycle ergometer (Restorative Therapies RT300 Supine)Device
Also called Restorative Therapies RT300 Supine
Routine physiotherapyOther
activities to assist with optimizing airway clearance and respiratory function, and, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out of bed mobility, and ambulation
| Study group | Role | What they receive |
|---|---|---|
| Early Cycling and routine physiotherapy | Experimental | Patients will receive 30 minutes of in-bed cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay Receives: Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine) |
| Routine physiotherapy | Active comparator | Patients will receive routine physiotherapy per current institutional practice Receives: Other: Routine physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient accrual
Measured: 2 years
Secondary outcomes (7)
Cycling protocol violations (% cycling protocol violations)
% cycling protocol violations
Measured: 2 years
Outcome measure ascertainment (% outcomes measured in hospital)
% outcomes measured in hospital
Measured: 2 years
Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors)
% outcomes at hospital discharge measured by blinded outcome assessors
Measured: 2 years
Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge
Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function
Measured: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively
Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge
Manual muscle testing using the Medical Research Council (MRC) Scale. The patient exerts a force against the examiner's resistance. Each muscle is assessed on a 6-point MRC scale (0=no contraction; 5=contraction sustained against maximal resistance).
Measured: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively
Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale)
The patient exerts a force against a small strain gauge that fits in the examiner's hand. .
Measured: From study admission to approximately 12 and 30 days, on average, respectively
2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge
Maximum distance walked in 2 minutes measured in metres on a continuous scale
Measured: From study admission to approximately 12 and 30 days, on average, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Hamilton Health Sciences Corporation, Technology Evaluation in the Elderly Network / Canadian Frailty Network, Canadian Institutes of Health Research (CIHR), Ontario Lung Association, Canadian Respiratory Research Network
- Responsible party
- Sponsor
- Investigators
- Michelle Kho, PT, PhD, Principal investigator, McMaster University School of Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377830
- Sponsor's protocol ID
- HIREB 14-531
- Acronym
- CYCLE Pilot
- Status last verified
- Nov 2022
- First submitted
- 26 Feb 2015
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Kho ME, Molloy AJ, Clarke FJ, Reid JC, Herridge MS, Karachi T, Rochwerg B, Fox-Robichaud AE, Seely AJ, Mathur S, Lo V, Burns KE, Ball IM, Pellizzari JR, Tarride JE, Rudkowski JC, Koo K, Heels-Ansdell D, Cook DJ. Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients. BMJ Open Respir Res. 2019 Feb 18;6(1):e000383. doi: 10.1136/bmjresp-2018-000383. eCollection 2019.
PubMed 30956804Heels-Ansdell D, Kelly L, O'Grady HK, Farley C, Reid JC, Berney S, Pastva AM, Burns KE, D'Aragon F, Herridge MS, Seely A, Rudkowski J, Rochwerg B, Fox-Robichaud A, Ball I, Lamontagne F, Duan EH, Tsang J, Archambault PM, Verceles AC, Muscedere J, Mehta S, English SW, Karachi T, Serri K, Reeve B, Thabane L, Cook D, Kho ME. Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial. JMIR Res Protoc. 2024 Oct 28;13:e54451. doi: 10.2196/54451.
PubMed 39467285O'Grady HK, Ball I, Berney S, Burns KEA, Cook DJ, Fox-Robichaud A, Herridge MS, Karachi T, Mathur S, Reid JC, Rochwerg B, Rollinson T, Rudkowski JC, Bosch J, Turkstra LS, Kho ME. Characterizing usual-care physical rehabilitation in Canadian intensive care unit patients: a secondary analysis of the Canadian multicentre Critical Care Cycling to Improve Lower Extremity Strength pilot randomized controlled trial. Can J Anaesth. 2024 Oct;71(10):1406-1416. doi: 10.1007/s12630-024-02838-7. Epub 2024 Sep 24.
PubMed 39317833Kho ME, Berney S, Pastva AM, Kelly L, Reid JC, Burns KEA, Seely AJ, D'Aragon F, Rochwerg B, Ball I, Fox-Robichaud AE, Karachi T, Lamontagne F, Archambault PM, Tsang JL, Duan EH, Muscedere J, Verceles AC, Serri K, English SW, Reeve BK, Mehta S, Rudkowski JC, Heels-Ansdell D, O'Grady HK, Strong G, Obrovac K, Ajami D, Camposilvan L, Tarride JE, Thabane L, Herridge MS, Cook DJ. Early In-Bed Cycle Ergometry in Mechanically Ventilated Patients. NEJM Evid. 2024 Jul;3(7):EVIDoa2400137. doi: 10.1056/EVIDoa2400137. Epub 2024 Jun 12.
PubMed 38865147Kho ME, Reid J, Molloy AJ, Herridge MS, Seely AJ, Rudkowski JC, Buckingham L, Heels-Ansdell D, Karachi T, Fox-Robichaud A, Ball IM, Burns KEA, Pellizzari JR, Farley C, Berney S, Pastva AM, Rochwerg B, D'Aragon F, Lamontagne F, Duan EH, Tsang JLY, Archambault P, English SW, Muscedere J, Serri K, Tarride JE, Mehta S, Verceles AC, Reeve B, O'Grady H, Kelly L, Strong G, Hurd AH, Thabane L, Cook DJ; CYCLE Investigators and the Canadian Critical Care Trials Group. Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients. BMJ Open. 2023 Jun 23;13(6):e075685. doi: 10.1136/bmjopen-2023-075685.
PubMed 37355270Takaoka A, Heels-Ansdell D, Cook DJ, Kho ME. The Association between Frailty and Short-Term Outcomes in an Intensive Care Unit Rehabilitation Trial: An Exploratory Analysis. J Frailty Aging. 2021;10(1):49-55. doi: 10.14283/jfa.2020.52.
PubMed 33331622Reid JC, McCaskell DS, Kho ME. Therapist perceptions of a rehabilitation research study in the intensive care unit: a trinational survey assessing barriers and facilitators to implementing the CYCLE pilot randomized clinical trial. Pilot Feasibility Stud. 2019 Nov 12;5:131. doi: 10.1186/s40814-019-0509-3. eCollection 2019.
PubMed 31741746McCaskell DS, Molloy AJ, Childerhose L, Costigan FA, Reid JC, McCaughan M, Clarke F, Cook DJ, Rudkowski JC, Farley C, Karachi T, Rochwerg B, Newman A, Fox-Robichaud A, Herridge MS, Lo V, Feltracco D, Burns KE, Porteous R, Seely AJE, Ball IM, Seczek A, Kho ME. Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. Trials. 2019 Aug 28;20(1):532. doi: 10.1186/s13063-019-3634-7.
PubMed 31455384Kho ME, Molloy AJ, Clarke F, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Pellizzari JR, Tarride JE, Mourtzakis M, Karachi T, Cook DJ; Canadian Critical Care Trials Group. CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients. BMJ Open. 2016 Apr 8;6(4):e011659. doi: 10.1136/bmjopen-2016-011659.
PubMed 27059469
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT02377830
- Acronym / sponsor ID
- CYCLE Pilot / HIREB 14-531
- Conditions
- Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation, Respiratory Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Hamilton Health Sciences Corporation, Technology Evaluation in the Elderly Network / Canadian Frailty Network, Canadian Institutes of Health Research (CIHR), Ontario Lung Association, Canadian Respiratory Research Network
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 4 Mar 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.
Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very weak and disabled. 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 involves use of special equipment that attaches to a patient's hospital bed, allowing them gentle exercise while in the ICU.
Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed cycling each day they are in the ICU or routine physiotherapy, both delivered by specially trained physiotherapists.
Outcomes: Feasibility: The investigators will study 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 investigators can systematically assess patients' strength.
Relevance: Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized study is the second of several future larger studies about in-bed cycling in the ICU.
Our pilot work includes CYCLE Pilot and CYCLE Vanguard. CYCLE Pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. CYCLE Vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. CYCLE Vanguard patients will be analyzed in the main CYCLE RCT (NCT03471247).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Cycling and routine physiotherapy | Experimental | Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine)Patients will receive 30 minutes of in-bed cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay |
| Routine physiotherapy | Active comparator | Other: Routine physiotherapyPatients will receive routine physiotherapy per current institutional practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults admitted to a medical-surgical ICU within the 1st 4 days of mechanical ventilation (MV) and 1st 7 days of ICU, and
- could ambulate independently before hospital admission.
Key exclusion criteria (6 listed)
- Acute condition impairing patients' ability to cycle (e.g., leg fracture),
- proven or suspected neuromuscular weakness affecting the legs (e.g., stroke or Guillain-Barré syndrome),
- unable to follow commands in English pre-ICU,
- temporary pacemaker,
- expected hospital mortality >90%,
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 cycle ergometer (Restorative Therapies RT300 Supine)Also: Restorative Therapies RT300 Supine | Device | Early Cycling and routine physiotherapy |
| Routine physiotherapyactivities to assist with optimizing airway clearance and respiratory function, and, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out of bed mobility, and ambulation | Other | Routine physiotherapy |
Primary outcome
Patient accrual
Time frame: 2 years
7 secondary outcomes
Cycling protocol violations (% cycling protocol violations)
Time frame: 2 years
Outcome measure ascertainment (% outcomes measured in hospital)
Time frame: 2 years
Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors)
Time frame: 2 years
Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge
Time frame: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively
Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge
Time frame: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively
Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale)
Time frame: From study admission to approximately 12 and 30 days, on average, respectively
2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge
Time frame: From study admission to approximately 12 and 30 days, on average, respectively
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 5 Dec 2022.
- Results publication: PubMed 30956804Kho ME, Molloy AJ, Clarke FJ, Reid JC, Herridge MS, Karachi T, Rochwerg B, Fox-Robichaud AE, Seely AJ, Mathur S, Lo V, Burns KE, Ball IM, Pellizzari JR, Tarride JE, Rudkowski JC, Koo K, Heels-Ansdell D, Cook DJ. Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients. BMJ Open Respir Res. 2019 Feb 18;6(1):e000383. doi: 10.1136/bmjresp-2018-000383. eCollection 2019.
- Derived from this study: PubMed 39467285Heels-Ansdell D, Kelly L, O'Grady HK, Farley C, Reid JC, Berney S, Pastva AM, Burns KE, D'Aragon F, Herridge MS, Seely A, Rudkowski J, Rochwerg B, Fox-Robichaud A, Ball I, Lamontagne F, Duan EH, Tsang J, Archambault PM, Verceles AC, Muscedere J, Mehta S, English SW, Karachi T, Serri K, Reeve B, Thabane L, Cook D, Kho ME. Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial. JMIR Res Protoc. 2024 Oct 28;13:e54451. doi: 10.2196/54451.
- Derived from this study: PubMed 39317833O'Grady HK, Ball I, Berney S, Burns KEA, Cook DJ, Fox-Robichaud A, Herridge MS, Karachi T, Mathur S, Reid JC, Rochwerg B, Rollinson T, Rudkowski JC, Bosch J, Turkstra LS, Kho ME. Characterizing usual-care physical rehabilitation in Canadian intensive care unit patients: a secondary analysis of the Canadian multicentre Critical Care Cycling to Improve Lower Extremity Strength pilot randomized controlled trial. Can J Anaesth. 2024 Oct;71(10):1406-1416. doi: 10.1007/s12630-024-02838-7. Epub 2024 Sep 24.
- Derived from this study: PubMed 38865147Kho ME, Berney S, Pastva AM, Kelly L, Reid JC, Burns KEA, Seely AJ, D'Aragon F, Rochwerg B, Ball I, Fox-Robichaud AE, Karachi T, Lamontagne F, Archambault PM, Tsang JL, Duan EH, Muscedere J, Verceles AC, Serri K, English SW, Reeve BK, Mehta S, Rudkowski JC, Heels-Ansdell D, O'Grady HK, Strong G, Obrovac K, Ajami D, Camposilvan L, Tarride JE, Thabane L, Herridge MS, Cook DJ. Early In-Bed Cycle Ergometry in Mechanically Ventilated Patients. NEJM Evid. 2024 Jul;3(7):EVIDoa2400137. doi: 10.1056/EVIDoa2400137. Epub 2024 Jun 12.
- Derived from this study: PubMed 37355270Kho ME, Reid J, Molloy AJ, Herridge MS, Seely AJ, Rudkowski JC, Buckingham L, Heels-Ansdell D, Karachi T, Fox-Robichaud A, Ball IM, Burns KEA, Pellizzari JR, Farley C, Berney S, Pastva AM, Rochwerg B, D'Aragon F, Lamontagne F, Duan EH, Tsang JLY, Archambault P, English SW, Muscedere J, Serri K, Tarride JE, Mehta S, Verceles AC, Reeve B, O'Grady H, Kelly L, Strong G, Hurd AH, Thabane L, Cook DJ; CYCLE Investigators and the Canadian Critical Care Trials Group. Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients. BMJ Open. 2023 Jun 23;13(6):e075685. doi: 10.1136/bmjopen-2023-075685.
- Derived from this study: PubMed 33331622Takaoka A, Heels-Ansdell D, Cook DJ, Kho ME. The Association between Frailty and Short-Term Outcomes in an Intensive Care Unit Rehabilitation Trial: An Exploratory Analysis. J Frailty Aging. 2021;10(1):49-55. doi: 10.14283/jfa.2020.52.
- Derived from this study: PubMed 31741746Reid JC, McCaskell DS, Kho ME. Therapist perceptions of a rehabilitation research study in the intensive care unit: a trinational survey assessing barriers and facilitators to implementing the CYCLE pilot randomized clinical trial. Pilot Feasibility Stud. 2019 Nov 12;5:131. doi: 10.1186/s40814-019-0509-3. eCollection 2019.
- Derived from this study: PubMed 31455384McCaskell DS, Molloy AJ, Childerhose L, Costigan FA, Reid JC, McCaughan M, Clarke F, Cook DJ, Rudkowski JC, Farley C, Karachi T, Rochwerg B, Newman A, Fox-Robichaud A, Herridge MS, Lo V, Feltracco D, Burns KE, Porteous R, Seely AJE, Ball IM, Seczek A, Kho ME. Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. Trials. 2019 Aug 28;20(1):532. doi: 10.1186/s13063-019-3634-7.
- Derived from this study: PubMed 27059469Kho ME, Molloy AJ, Clarke F, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Pellizzari JR, Tarride JE, Mourtzakis M, Karachi T, Cook DJ; Canadian Critical Care Trials Group. CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients. BMJ Open. 2016 Apr 8;6(4):e011659. doi: 10.1136/bmjopen-2016-011659.
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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 Kho, PT, PhD principal investigator
McMaster University School of Rehabilitation Science
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing In-bed cycle ergometer (Restorative Therapies RT300 Supine) and Routine physiotherapy in people with Intensive Care Unit Acquired Weakness and Critical Care, run by McMaster University at 9 sites in 3 countries.
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 2 inclusion and 6 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 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, United States, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient accrual (time frame: 2 years). 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 NCT02377830, which also lists 9 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 5 Dec 2022; AzTrials last refreshed its copy on 1 Nov 2026.