Rehabilitation Following Critical Illness
A Randomised Controlled Trial of Rehabilitation Following Critical Illness: A Short Term Feasibility and Follow-Up Pilot Study
1 other identifier
interventional
20
1 country
2
Brief Summary
The principal research question to be answered by this study is whether an exercise based rehabilitative intervention following critical illness can generate improvements in exercise capacity and quality of life beyond current (usual) care. The investigators will also aim to demonstrate that such an intervention is both practical and cost-effective.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2009
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJanuary 6, 2015
January 1, 2015
3 years
September 11, 2009
January 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incremental Shuttle Walk Test
Eight weeks
Secondary Outcomes (1)
Health Related Quality of Life
Eight weeks
Study Arms (2)
Control
NO INTERVENTIONIntervention
EXPERIMENTALPulmonary Rehabilitation
Interventions
Eight week programme of twice-weekly (sixteen sessions) supervised exercise and education sessions. Exercise will include aerobic cardiovascular and upper and lower limb strengthening exercises. Each session will comprise a warm-up period, followed by individualised exercises, and completed with a cool-down, and last approximately 40minutes. Aerobic exercise will be prescribed based on the results of walking tests and include walking, step-ups, cycling, and strength prescription according to the repetition maximum principle. Patients will complete three sets using this weight. Furthermore Borg scores will be used within each session to guide and direct exercise intensity. A home exercise programme will also be designed and accompanied by a manual detailing the individual warm-up, exercises and cool-down, and diary sections to record independent activity. Each session will also include an education session where relevant.
Eligibility Criteria
You may qualify if:
- Age \>18 years AND admitted to critical care unit
- Ventilated \>48-hours (via endotracheal tube) OR received continuous non- invasive ventilation (NIV)/non-invasive continuous positive airways pressure (CPAP)
- Admitted to ICU \> 48-hours and evidence of SIRS
- Glasgow Coma Score (GCS) 15 (of 15) AND Abbreviated Mini-Mental Test Score (AMMTS) \>/= 8 (of 10) on enrolment into rehabilitation programme
- Mobilising on ward to a degree sufficient as to begin a majority of proposed exercises. Clinical stability for observed exercise as judged by trial team is a prerequisite.
- Participant willingness to complete a programme of exercise based therapy aimed at reducing weakness and shortness of breath: subjective weakness or dyspnoea relative to their pre-admission state is implicit
You may not qualify if:
- Patients referred for terminal care or prognosis likely to be less than 12-months
- Unstable coronary artery syndrome
- Limb amputation (given special requirement for orthotics/rehabilitation)
- Critical peripheral vascular disease awaiting re-vascularisation procedure (or claudication distance \<100 metres)
- Stroke with hemiparesis (likely need for specialised rehabilitation/stay on stroke unit)
- Severe, disabling locomotor problem or severe burns, which prevent effective participation in the exercises contained in the rehabilitation programme.
- Psychiatric disease necessitating anti-psychotic medication, deliberate drug overdose as the admitting ICU indication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
- Patients undergoing renal haemodialysis (given the associated commitment to outpatient attendance)
- Extra contractual ICU referral (only if distance greater than suitable for twice weekly travel)
- Coagulopathy e.g. warfarin use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St.Thomas' Hospital
London, London, SE1 7EH, United Kingdom
King's College Hospital
London, London, SE5 9RS, United Kingdom
Related Publications (1)
Connolly B, Thompson A, Douiri A, Moxham J, Hart N. Exercise-based rehabilitation after hospital discharge for survivors of critical illness with intensive care unit-acquired weakness: A pilot feasibility trial. J Crit Care. 2015 Jun;30(3):589-98. doi: 10.1016/j.jcrc.2015.02.002. Epub 2015 Feb 7.
PMID: 25703957DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicholas Hart, BSc (Hons), MBBS, MRCP, PhD
St.Thomas' Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Fellow
Study Record Dates
First Submitted
September 11, 2009
First Posted
September 14, 2009
Study Start
November 1, 2009
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
January 6, 2015
Record last verified: 2015-01