Cardiac DiseaseCardiO CycleNCT02976415
In-Bed Cycling in ICU Patients Post Cardiac Surgery
A study testing In-Bed Cycling in people with Cardiac Disease and Critical Illness, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to determine if in-bed cycling is safe and feasible in critically-ill patients after open heart surgery. The investigators hypothesize that in-bed cycling can be safely used with this population and that it is feasible to use in a fast-paced cardiac intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Critical Illness, Critical Illness Polyneuropathy
- What is being tested?
- In-Bed Cycling
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 28 Aug 2017to 29 Mar 2019
- 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
- Male and female adults patients aged 18 years and greater
- History of cardiac surgery in the past seven days
- Admitted to the cardiac surgery ICU for greater than 3 days but less than 7 days
- Mechanically ventilated for at least 72 hours and expected to remain ventilated for at least two more days
- Able to ambulate independently, with or without a gait aid, prior to hospital admission
Who cannot join
- Uncomplicated post-operative course with expected discharge to ward within 24 to 72 hours
- Previous lower extremity amputation
- Open or unstable saphenous vein graft sites
- Inability to understand English
- Body size and/or weight that is incompatible with the bedside ergometer
- Patients who are not expected to survive their ICU stay
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CardiO Cycle: A Pilot Safety and Feasibility Study of In-Bed Cycling in Patients Post Cardiac Surgery
The purpose of this study is to determine if in-bed cycling is safe and feasible in critically-ill patients after open heart surgery. The investigators hypothesize that in-bed cycling can be safely used with this population and that it is feasible to use in a fast-paced cardiac intensive care unit.
Read the detailed description
Background: Advances in medical science and technologies have lead to more effective management of critically-ill patients with a subsequent improvement in ICU survival rates. Patients who survive their ICU stay are often left with post-ICU impairments including muscle weakness and functional limitations. Cardiac surgeries are commonly performed worldwide with the majority of patients requiring post-operative ICU care. In the past decade, patients who qualify for cardiac surgery tend to be older, have a great number of co-morbidities and are more likely to require a prolonged ICU stay. The effectiveness of physiotherapy and various rehabilitation modalities in patients both pre- and post cardiac surgery has been investigated. However, to date no study specifically addresses the feasibility and safety of in-bed cycling in patients undergoing cardiac surgery who require prolonged critical care.
Principle Research Question: Is in-bed cycling a safe and feasible intervention in patients post cardiac surgery that require a prolonged stay in critical care?
Methods: Adult patients post-cardiac surgery admitted to the cardiac surgery ICU who will remain intubated and ventilated for at least 72 hours will be eligible for enrollment. Participants will receive 20 minutes of in-bed cycling plus routine physiotherapy performed by critical care physiotherapists. Patients will be enrolled for 28 days or until they are able to ambulate.
Primary Outcomes: Safety of bedside cycling will be evaluated by monitoring the number of adverse events that occur during each cycling session. Feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least eighty percent of the time that cycling is appropriate.
Relevance: Before conducting a larger randomized controlled trial investigating the effectiveness of in-bed cycling in the critically-ill cardiac surgery population, the safety of this intervention needs to be determined. This will be the first study in a program of research evaluating bedside cycling in the cardiac surgical ICU.
- Conditions
- Cardiac Disease, Critical Illness, Critical Illness Polyneuropathy, Critical Illness Myopathy, Thoracic Surgery
- Being tested
- In-Bed Cycling
- Keywords
- Cardiac Surgery, Physiotherapy, In-Bed Cycling, Mechanical Ventilation, Cycle Ergometry, Early Mobilization, Rehabilitation, Critical Care, Intensive Care Unit
- Medical subject headings
- Heart Diseases, Critical Illness, Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Bed CyclingOther
Also called Bedside Cycling, Bedside Ergometry
20 minutes of in-bed cycling, either active, passive or a combination of active and passive.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of safety events that occur during cycling sessions
Potential safety events include:
- Hypertension (systolic blood pressure greater than 160 mmHg)
- Hypotension (systolic blood pressure less than 90 mmHg)
- Oxygen desaturation to less than 85% for more than two minutes
- Cardiorespiratory arrest
- Removal of any lines or tubes (chest tubes, pulmonary artery catheter, nasal-gastric tube, Jackson-Pratt drains, central venous catheter, endotracheal tube, tracheostomy decannulation)
- New onset cardiac arrhythmias (atrial fibrillation, bigeminy, trigeminy, junctional, heart block rhythms)
- Saphenous vein graft dehiscence
- New onset agitation
Measured: From date of study enrollment until the date of study completion, up to 28 days maximum
Feasibility of completing 80% of eligible cycling sessions
The feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least 80% of the time that cycling is appropriate.
Measured: From date of study enrollment to the date of study completion, up to 28 days maximum
Secondary outcomes (3)
Feasibility of Completing Hand Grip Strength at ICU Awakening and ICU Discharge
Hand grip strength will be assessed using a hand-held JAMAR dynamometer. Patients will be seated with elbow bent to 90 degrees. Patients will be asked to "squeeze the handle as hard as possible" and the maximum score will be taken after five seconds. Average of three trials will be documented.
Measured: When patient awake (unspecified time, patient dependent), at completion of study involvement (maximum: day 28 of ICU)
Two Minute Walk Test
In an unobstructed area, patients will be instructed to walk back and forth covering as much distance as possible in two minutes. Gait aids may be used and patients are permitted to rest as needed during the test. No encouragement will be provided during the two minute test. The number of rest stops, the duration of the rests and the distance traveled in meters will be documented.
Measured: At ICU Awakening (an estimated 8 days after study enrollment) and at the completion of the study (maximum: day 28 of ICU)
Functional Status Score for the ICU (FSS-ICU)
The FSS-ICU is a five-item functional measure that evaluates the ability of each client to perform five specific tasks (rolling, supine to sit, sitting at edge of bed, sit to stand, walking). Each scale is assessed using an 8-point ordinal scale (0 - inability to perform the task to 7 - able to perform the task independently)
Measured: Assessed daily, up to a maximum of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start28 Aug 2017
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia Newman, Hamilton Health Sciences Corporation
- Investigators
- Anastasia N Newman, PhD Student, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976415
- Sponsor's protocol ID
- 2016-1999-GRA
- Acronym
- CardiO Cycle
- Status last verified
- Jul 2020
- First submitted
- 8 Nov 2016
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Newman ANL, Kho ME, Harris JE, Zamir N, McDonald E, Fox-Robichaud A, Solomon P; Canadian Critical Care Trials Group. CardiO Cycle: a pilot feasibility study of in-bed cycling in critically ill patients post cardiac surgery. Pilot Feasibility Stud. 2021 Jan 7;7(1):13. doi: 10.1186/s40814-020-00760-5.
PubMed 33407923
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardiO Cycle: A Pilot Safety and Feasibility Study of In-Bed Cycling in Patients Post Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02976415
- Acronym / sponsor ID
- CardiO Cycle / 2016-1999-GRA
- Conditions
- Cardiac Disease, Critical Illness, Critical Illness Polyneuropathy, Critical Illness Myopathy, Thoracic Surgery
- Keywords
- Cardiac Surgery, Physiotherapy, In-Bed Cycling, Mechanical Ventilation, Cycle Ergometry, Early Mobilization, Rehabilitation, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 29 Nov 2016 (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.
The purpose of this study is to determine if in-bed cycling is safe and feasible in critically-ill patients after open heart surgery. The investigators hypothesize that in-bed cycling can be safely used with this population and that it is feasible to use in a fast-paced cardiac intensive care unit.
Detailed description
Background: Advances in medical science and technologies have lead to more effective management of critically-ill patients with a subsequent improvement in ICU survival rates. Patients who survive their ICU stay are often left with post-ICU impairments including muscle weakness and functional limitations. Cardiac surgeries are commonly performed worldwide with the majority of patients requiring post-operative ICU care. In the past decade, patients who qualify for cardiac surgery tend to be older, have a great number of co-morbidities and are more likely to require a prolonged ICU stay. The effectiveness of physiotherapy and various rehabilitation modalities in patients both pre- and post cardiac surgery has been investigated. However, to date no study specifically addresses the feasibility and safety of in-bed cycling in patients undergoing cardiac surgery who require prolonged critical care.
Principle Research Question: Is in-bed cycling a safe and feasible intervention in patients post cardiac surgery that require a prolonged stay in critical care?
Methods: Adult patients post-cardiac surgery admitted to the cardiac surgery ICU who will remain intubated and ventilated for at least 72 hours will be eligible for enrollment. Participants will receive 20 minutes of in-bed cycling plus routine physiotherapy performed by critical care physiotherapists. Patients will be enrolled for 28 days or until they are able to ambulate.
Primary Outcomes: Safety of bedside cycling will be evaluated by monitoring the number of adverse events that occur during each cycling session. Feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least eighty percent of the time that cycling is appropriate.
Relevance: Before conducting a larger randomized controlled trial investigating the effectiveness of in-bed cycling in the critically-ill cardiac surgery population, the safety of this intervention needs to be determined. This will be the first study in a program of research evaluating bedside cycling in the cardiac surgical ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female adults patients aged 18 years and greater
- History of cardiac surgery in the past seven days
- Admitted to the cardiac surgery ICU for greater than 3 days but less than 7 days
- Mechanically ventilated for at least 72 hours and expected to remain ventilated for at least two more days
- Able to ambulate independently, with or without a gait aid, prior to hospital admission
Key exclusion criteria (6 listed)
- Uncomplicated post-operative course with expected discharge to ward within 24 to 72 hours
- Previous lower extremity amputation
- Open or unstable saphenous vein graft sites
- Inability to understand English
- Body size and/or weight that is incompatible with the bedside ergometer
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 CyclingAlso: Bedside Cycling, Bedside Ergometry20 minutes of in-bed cycling, either active, passive or a combination of active and passive. | Other | – |
Primary outcome
Number of safety events that occur during cycling sessions
Time frame: From date of study enrollment until the date of study completion, up to 28 days maximum
Potential safety events include: * Hypertension (systolic blood pressure greater than 160 mmHg) * Hypotension (systolic blood pressure less than 90 mmHg) * Oxygen desaturation to less than 85% for more than two minutes * Cardiorespiratory arrest * Removal of any lines or tubes (chest tubes, pulmonary artery catheter, nasal-gastric tube, Jackson-Pratt drains, central venous catheter, endotracheal tube, tracheostomy decannulation) * New onset cardiac arrhythmias (atrial fibrillation, bigeminy, trigeminy, junctional, heart block rhythms) * Saphenous vein graft dehiscence * New onset agitation
Feasibility of completing 80% of eligible cycling sessions
Time frame: From date of study enrollment to the date of study completion, up to 28 days maximum
The feasibility of implementing in-bed cycling into daily physiotherapy practice will be evaluated by determining if cycling sessions can be conducted at least 80% of the time that cycling is appropriate.
3 secondary outcomes
Feasibility of Completing Hand Grip Strength at ICU Awakening and ICU Discharge
Time frame: When patient awake (unspecified time, patient dependent), at completion of study involvement (maximum: day 28 of ICU)
Two Minute Walk Test
Time frame: At ICU Awakening (an estimated 8 days after study enrollment) and at the completion of the study (maximum: day 28 of ICU)
Functional Status Score for the ICU (FSS-ICU)
Time frame: Assessed daily, up to a maximum of 28 days
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 31 Jul 2020.
- Derived from this study: PubMed 33407923Newman ANL, Kho ME, Harris JE, Zamir N, McDonald E, Fox-Robichaud A, Solomon P; Canadian Critical Care Trials Group. CardiO Cycle: a pilot feasibility study of in-bed cycling in critically ill patients post cardiac surgery. Pilot Feasibility Stud. 2021 Jan 7;7(1):13. doi: 10.1186/s40814-020-00760-5.
- Individual participant dataSharing planned: No
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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.
Anastasia N Newman, PhD Student principal investigator
Hamilton Health Sciences Corporation
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 Cycling in people with Cardiac Disease and Critical Illness, run by Hamilton Health Sciences Corporation 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 5 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 31 Jul 2020. 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 safety events that occur during cycling sessions (time frame: From date of study enrollment until the date of study completion, up to 28 days maximum). The study lists 2 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 NCT02976415, which also lists 1 linked publication.
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 31 Jul 2020.