Clinical trial NCT02976415: In-Bed Cycling in ICU Patients Post Cardiac Surgery
Official title: CardiO Cycle: A Pilot Safety and Feasibility Study of In-Bed Cycling in Patients Post Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Intensive Care Unit
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of safety events that occur during cycling sessions
timeFrame: From date of study enrollment until the date of study completion, up to 28 days maximum
measure: Feasibility of completing 80% of eligible cycling sessions
timeFrame: From date of study enrollment to the date of study completion, up to 28 days maximum
Secondary outcomes:
measure: Feasibility of Completing Hand Grip Strength at ICU Awakening and ICU Discharge
timeFrame: When patient awake (unspecified time, patient dependent), at completion of study involvement (maximum: day 28 of ICU)
measure: Two Minute Walk Test
timeFrame: At ICU Awakening (an estimated 8 days after study enrollment) and at the completion of the study (maximum: day 28 of ICU)
measure: Functional Status Score for the ICU (FSS-ICU)
timeFrame: Assessed daily, up to a maximum of 28 days
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hosptial
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Anastasia N Newman, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.