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Topic: Clinical Trial
Early Exercise in Critically ill Youth and Children, a Preliminary Evaluation (The wEECYCLE Pilot trial)
Awlad thani,Saif; Khawaji,Adeeb; Choong,Karen; Al-Harbi,Samah; Clerk,Heather; Neu,Charmaine; Timmons,Brian; Thabane,Lehana; Cheng,Ji;
Zheng,Katina; Sarti, Aimee
Pediatric Critical Care Unit, McMaster Children Hospital, McMaster University, Hamilton, Ontario, Canada
The study is conducted on behalf of the Canadian Critical Care Trials Group
Grant acknowledgements:
We acknowledge Regional Medical Associate,Resident Research Grant for funding and Restorative Therapies inc. for RT300 supply.
Abstract:
Aims & Objectives:
Early mobilization and rehabilitation improves long-term functional outcome in adult intensive care unit (ICU) survivors, but has not been evaluated in children.The objective of this pilot trials is to evaluate the feasibility of conducting a multi-centre randomized controlled trial (RCT), evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy alone, on functional recovery in critically ill children.
Methods
Children aged 3 to 18 years admittedto the PICU at McMaster Children’s Hospital who were limited to bed-rest/bed mobility, not at their baseline function, were haemodynamically stable and had no contraindication to mobilization, were randomized in a 2:1 ratio to early in-bed cycling (within 24 hours of enrolment) vs. usual care physiotherapy.In-bed cycling is applied for 30 minutes daily during weekdays, for a maximumof 7 days, or till baseline functional mobility was achieved for 2 consecutive days.Primary outcomes were feasibility and protocol adherence. Target sample size is 30, over 12 months. Secondary outcomes are functional outcome at 1 month and PICU related morbidities.
Results
A total of 21patients were enrolled between September 2015 to June 2016; 14 to the cycling arm and 7 to usual care. To date, our consent rate is 95.5% and 1-month follow-up rate is100%. The median time to intervention after consent is 2.5 hrs (minimum 0.5hr, maximum 20hr) for intervention arm ( In-bed cycling). The median time to physiotherapy after consent is 20 hr (minimum 0.2hr hr, maximum 288h) for control arm ( physiotherapy alone).
37 cycling sessions have been applied out of 67 planned cycling sessions.30 session were not conducted either because of presence of contraindications to cycling (9,30%), patient or parent refusal (7, 23%) or research personnel were not available ( 14,47%).
There were no adverse events attributed to cycling intervention during study period.
Conclusions
To date, our result suggests that enrolment into this RCT and initiation of mobilization within 24 hr of randomization is feasible. We anticipate completion of enrolment in 4 months. The main threat to feasibility is availability of research personnel to execute cycling.
References:
1) Iwashyna T, Ely W, Smith D, Langa K: Long-term Cognitive Impairement and Functional Disability Among Survivors of Severe Sepsis. JAMA : the journal of the American Medical Association 2010, 304:1787-1794
2) Stiller K: Physiotherapy in Intensive Care. An Updated Systematic Review. Chest 2013, 144:825-847
3) Cuthbertson BH, Rattray J, Campbell MK et al: The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ 2009, 339:b3723.
4) Choong K, Fraser D, Hutchison J et al: Acute Rehabilitation Practices in Critically Ill Children: A Multi-center Study. Pediatric Critical Care Medicine 2014, 15:suppl_12-13
5)Choong K, Chacon M, Walker R et al: Early Rehabilitation in Critically Ill Children: A Pilot Study. Pediatric Critical Care Medicine 2014, 15:8.
6) Choong K, Chacon M, Walker R et al: Early Rehabilitation in Critically Ill Children: A Pilot Study. Pediatric Critical Care Medicine 2014, 15:Suppl_8.
Topic: Clinical Trial
Early Exercise in Critically ill Youth and Children, a Preliminary Evaluation (The wEECYCLE Pilot trial)
Awlad thani,Saif; Khawaji,Adeeb; Choong,Karen; Al-Harbi,Samah; Clerk,Heather; Neu,Charmaine; Timmons,Brian; Thabane,Lehana; Cheng,Ji;
Zheng,Katina; Sarti, Aimee
Pediatric Critical Care Unit, McMaster Children Hospital, McMaster University, Hamilton, Ontario, Canada
The study is conducted on behalf of the Canadian Critical Care Trials Group
Grant acknowledgements:
We acknowledge Regional Medical Associate,Resident Research Grant for funding and Restorative Therapies inc. for RT300 supply.
Abstract:
Aims & Objectives:
Early mobilization and rehabilitation improves long-term functional outcome in adult intensive care unit (ICU) survivors, but has not been evaluated in children.The objective of this pilot trials is to evaluate the feasibility of conducting a multi-centre randomized controlled trial (RCT), evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy alone, on functional recovery in critically ill children.
Methods
Children aged 3 to 18 years admittedto the PICU at McMaster Children’s Hospital who were limited to bed-rest/bed mobility, not at their baseline function, were haemodynamically stable and had no contraindication to mobilization, were randomized in a 2:1 ratio to early in-bed cycling (within 24 hours of enrolment) vs. usual care physiotherapy.In-bed cycling is applied for 30 minutes daily during weekdays, for a maximumof 7 days, or till baseline functional mobility was achieved for 2 consecutive days.Primary outcomes were feasibility and protocol adherence. Target sample size is 30, over 12 months. Secondary outcomes are functional outcome at 1 month and PICU related morbidities.
Results
A total of 21patients were enrolled between September 2015 to June 2016; 14 to the cycling arm and 7 to usual care. To date, our consent rate is 95.5% and 1-month follow-up rate is100%. The median time to intervention after consent is 2.5 hrs (minimum 0.5hr, maximum 20hr) for intervention arm ( In-bed cycling). The median time to physiotherapy after consent is 20 hr (minimum 0.2hr hr, maximum 288h) for control arm ( physiotherapy alone).
37 cycling sessions have been applied out of 67 planned cycling sessions.30 session were not conducted either because of presence of contraindications to cycling (9,30%), patient or parent refusal (7, 23%) or research personnel were not available ( 14,47%).
There were no adverse events attributed to cycling intervention during study period.
Conclusions
To date, our result suggests that enrolment into this RCT and initiation of mobilization within 24 hr of randomization is feasible. We anticipate completion of enrolment in 4 months. The main threat to feasibility is availability of research personnel to execute cycling.
References:
1) Iwashyna T, Ely W, Smith D, Langa K: Long-term Cognitive Impairement and Functional Disability Among Survivors of Severe Sepsis. JAMA : the journal of the American Medical Association 2010, 304:1787-1794
2) Stiller K: Physiotherapy in Intensive Care. An Updated Systematic Review. Chest 2013, 144:825-847
3) Cuthbertson BH, Rattray J, Campbell MK et al: The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ 2009, 339:b3723.
4) Choong K, Fraser D, Hutchison J et al: Acute Rehabilitation Practices in Critically Ill Children: A Multi-center Study. Pediatric Critical Care Medicine 2014, 15:suppl_12-13
5)Choong K, Chacon M, Walker R et al: Early Rehabilitation in Critically Ill Children: A Pilot Study. Pediatric Critical Care Medicine 2014, 15:8.
6) Choong K, Chacon M, Walker R et al: Early Rehabilitation in Critically Ill Children: A Pilot Study. Pediatric Critical Care Medicine 2014, 15:Suppl_8.
Topic: Clinical Trial
Early Exercise in Critically ill Youth and Children, a Preliminary Evaluation (The wEECYCLE Pilot trial)
Awlad thani,Saif; Khawaji,Adeeb; Choong,Karen; Al-Harbi,Samah; Clerk,Heather; Neu,Charmaine; Timmons,Brian; Thabane,Lehana; Cheng,Ji;
Zheng,Katina; Sarti, Aimee
Pediatric Critical Care Unit, McMaster Children Hospital, McMaster University, Hamilton, Ontario, Canada
The study is conducted on behalf of the Canadian Critical Care Trials Group
Grant acknowledgements:
We acknowledge Regional Medical Associate,Resident Research Grant for funding and Restorative Therapies inc. for RT300 supply.
Abstract:
Aims & Objectives:
Early mobilization and rehabilitation improves long-term functional outcome in adult intensive care unit (ICU) survivors, but has not been evaluated in children.The objective of this pilot trials is to evaluate the feasibility of conducting a multi-centre randomized controlled trial (RCT), evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy alone, on functional recovery in critically ill children.
Methods
Children aged 3 to 18 years admittedto the PICU at McMaster Children’s Hospital who were limited to bed-rest/bed mobility, not at their baseline function, were haemodynamically stable and had no contraindication to mobilization, were randomized in a 2:1 ratio to early in-bed cycling (within 24 hours of enrolment) vs. usual care physiotherapy.In-bed cycling is applied for 30 minutes daily during weekdays, for a maximumof 7 days, or till baseline functional mobility was achieved for 2 consecutive days.Primary outcomes were feasibility and protocol adherence. Target sample size is 30, over 12 months. Secondary outcomes are functional outcome at 1 month and PICU related morbidities.
Results
A total of 21patients were enrolled between September 2015 to June 2016; 14 to the cycling arm and 7 to usual care. To date, our consent rate is 95.5% and 1-month follow-up rate is100%. The median time to intervention after consent is 2.5 hrs (minimum 0.5hr, maximum 20hr) for intervention arm ( In-bed cycling). The median time to physiotherapy after consent is 20 hr (minimum 0.2hr hr, maximum 288h) for control arm ( physiotherapy alone).
37 cycling sessions have been applied out of 67 planned cycling sessions.30 session were not conducted either because of presence of contraindications to cycling (9,30%), patient or parent refusal (7, 23%) or research personnel were not available ( 14,47%).
There were no adverse events attributed to cycling intervention during study period.
Conclusions
To date, our result suggests that enrolment into this RCT and initiation of mobilization within 24 hr of randomization is feasible. We anticipate completion of enrolment in 4 months. The main threat to feasibility is availability of research personnel to execute cycling.
References:
1) Iwashyna T, Ely W, Smith D, Langa K: Long-term Cognitive Impairement and Functional Disability Among Survivors of Severe Sepsis. JAMA : the journal of the American Medical Association 2010, 304:1787-1794
2) Stiller K: Physiotherapy in Intensive Care. An Updated Systematic Review. Chest 2013, 144:825-847
3) Cuthbertson BH, Rattray J, Campbell MK et al: The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ 2009, 339:b3723.
4) Choong K, Fraser D, Hutchison J et al: Acute Rehabilitation Practices in Critically Ill Children: A Multi-center Study. Pediatric Critical Care Medicine 2014, 15:suppl_12-13
5)Choong K, Chacon M, Walker R et al: Early Rehabilitation in Critically Ill Children: A Pilot Study. Pediatric Critical Care Medicine 2014, 15:8.
6) Choong K, Chacon M, Walker R et al: Early Rehabilitation in Critically Ill Children: A Pilot Study. Pediatric Critical Care Medicine 2014, 15:Suppl_8.
Topic: Clinical Trial
Early Exercise in Critically ill Youth and Children, a Preliminary Evaluation (The wEECYCLE Pilot trial)
Awlad thani,Saif; Khawaji,Adeeb; Choong,Karen; Al-Harbi,Samah; Clerk,Heather; Neu,Charmaine; Timmons,Brian; Thabane,Lehana; Cheng,Ji;
Zheng,Katina; Sarti, Aimee
Pediatric Critical Care Unit, McMaster Children Hospital, McMaster University, Hamilton, Ontario, Canada
The study is conducted on behalf of the Canadian Critical Care Trials Group
Grant acknowledgements:
We acknowledge Regional Medical Associate,Resident Research Grant for funding and Restorative Therapies inc. for RT300 supply.
Abstract:
Aims & Objectives:
Early mobilization and rehabilitation improves long-term functional outcome in adult intensive care unit (ICU) survivors, but has not been evaluated in children.The objective of this pilot trials is to evaluate the feasibility of conducting a multi-centre randomized controlled trial (RCT), evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy alone, on functional recovery in critically ill children.
Methods
Children aged 3 to 18 years admittedto the PICU at McMaster Children’s Hospital who were limited to bed-rest/bed mobility, not at their baseline function, were haemodynamically stable and had no contraindication to mobilization, were randomized in a 2:1 ratio to early in-bed cycling (within 24 hours of enrolment) vs. usual care physiotherapy.In-bed cycling is applied for 30 minutes daily during weekdays, for a maximumof 7 days, or till baseline functional mobility was achieved for 2 consecutive days.Primary outcomes were feasibility and protocol adherence. Target sample size is 30, over 12 months. Secondary outcomes are functional outcome at 1 month and PICU related morbidities.
Results
A total of 21patients were enrolled between September 2015 to June 2016; 14 to the cycling arm and 7 to usual care. To date, our consent rate is 95.5% and 1-month follow-up rate is100%. The median time to intervention after consent is 2.5 hrs (minimum 0.5hr, maximum 20hr) for intervention arm ( In-bed cycling). The median time to physiotherapy after consent is 20 hr (minimum 0.2hr hr, maximum 288h) for control arm ( physiotherapy alone).
37 cycling sessions have been applied out of 67 planned cycling sessions.30 session were not conducted either because of presence of contraindications to cycling (9,30%), patient or parent refusal (7, 23%) or research personnel were not available ( 14,47%).
There were no adverse events attributed to cycling intervention during study period.
Conclusions
To date, our result suggests that enrolment into this RCT and initiation of mobilization within 24 hr of randomization is feasible. We anticipate completion of enrolment in 4 months. The main threat to feasibility is availability of research personnel to execute cycling.
References:
1) Iwashyna T, Ely W, Smith D, Langa K: Long-term Cognitive Impairement and Functional Disability Among Survivors of Severe Sepsis. JAMA : the journal of the American Medical Association 2010, 304:1787-1794
2) Stiller K: Physiotherapy in Intensive Care. An Updated Systematic Review. Chest 2013, 144:825-847
3) Cuthbertson BH, Rattray J, Campbell MK et al: The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ 2009, 339:b3723.
4) Choong K, Fraser D, Hutchison J et al: Acute Rehabilitation Practices in Critically Ill Children: A Multi-center Study. Pediatric Critical Care Medicine 2014, 15:suppl_12-13
5)Choong K, Chacon M, Walker R et al: Early Rehabilitation in Critically Ill Children: A Pilot Study. Pediatric Critical Care Medicine 2014, 15:8.
6) Choong K, Chacon M, Walker R et al: Early Rehabilitation in Critically Ill Children: A Pilot Study. Pediatric Critical Care Medicine 2014, 15:Suppl_8.
