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Rehabilitation Following Critical Illness

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ClinicalTrials.gov Identifier: NCT00976807
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Bronwen Connolly, Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Critical Illness Myopathy Other: Pulmonary Rehabilitation Not Applicable

Detailed Description:

Advances in medicine mean that an increasing number of critically ill people, including those with severe pneumonia (lung infection), chronic obstructive pulmonary disease (also known as emphysema or chronic bronchitis) or the "acute respiratory distress syndrome", survive admission to the hospital intensive care unit. Survivors report health problems such as breathlessness and weakness long after discharge. In a study monitoring over 800 patients discharged from an intensive care ward, over half required some form of caregiver assistance after 1-year.

Whilst on intensive care, patients usually require help to breathe from a ventilator machine and become immobilised. This leads to weak breathing muscles in three quarters of patients, as well as weak and wasted arm and leg muscles. Survivors struggle to regain their previous level of daily activity and function, limited by shortness of breath, muscle weakness and tiredness. It is recognised that people with chronic lung problems, such as chronic obstructive pulmonary disease, face similar problems. In this condition, exercise based therapy has been shown to improve muscle strength, walking ability, shortness of breath, and importantly quality of life.

Given these experiences, a new trial will evaluate a novel programme of exercise-based rehabilitation training in patients discharged from intensive care. The programme will last for 8-weeks and will use exercises designed to correct the breathing and limb muscle weakness, as well as education to help patients cope more effectively. The programme will begin as soon as possible following discharge from hospital and will be conducted on a mostly outpatient basis until the course is completed. By speeding the recovery of strength and activity, it is anticipated that quality of life will be improved, which this trial will attempt to measure.

The rehabilitation programme will include aerobic cardiovascular, and upper and lower limb strengthening exercises, in addition to relevant education sessions.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Rehabilitation Following Critical Illness: A Short Term Feasibility and Follow-Up Pilot Study
Study Start Date : November 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
No Intervention: Control
Experimental: Intervention
Pulmonary Rehabilitation
Other: Pulmonary Rehabilitation

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.





Primary Outcome Measures :
  1. Incremental Shuttle Walk Test [ Time Frame: Eight weeks ]

Secondary Outcome Measures :
  1. Health Related Quality of Life [ Time Frame: Eight weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Additional exclusion criteria for muscle biopsy samples:

  • Coagulopathy e.g. warfarin use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976807


Locations
United Kingdom
St.Thomas' Hospital
London, United Kingdom, SE1 7EH
King's College Hospital
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Study Director: Nicholas Hart, BSc (Hons), MBBS, MRCP, PhD St.Thomas' Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bronwen Connolly, Clinical Research Fellow, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00976807     History of Changes
Other Study ID Numbers: RJ1 09/N153
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015

Keywords provided by Bronwen Connolly, Guy's and St Thomas' NHS Foundation Trust:
critical care
intensive care
weakness
myopathy
paresis
rehabilitation

Additional relevant MeSH terms:
Critical Illness
Muscular Diseases
Disease Attributes
Pathologic Processes
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases