Rehabilitation Following Critical Illness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Bronwen Connolly, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00976807
First received: September 11, 2009
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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 Intervention
Critical Illness Myopathy
Other: Pulmonary Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Incremental Shuttle Walk Test [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health Related Quality of Life [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 148
Study Start Date: November 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976807

Contacts
Contact: Nicholas Hart, BSc (Hons), MBBS, MRCP, PhD +44 207 188 7608 nicholas.hart@gstt.nhs.uk
Contact: Bronwen Connolly, BSc (Hons), MSc +44 203 299 9000 ext 2080 bronwen.connolly@nhs.net

Locations
United Kingdom
St.Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Nicholas Hart, BSc (Hons), MBBS, MRCP, PhD    +44 207 188 7608    nicholas.hart@gstt.nhs.uk   
Contact: Bronwen Connolly, BSc (Hons), MSc    +44 203 299 9000 ext 2080    bronwen.connolly@nhs.net   
Principal Investigator: Bronwen Connolly, BSc (Hons), MSc         
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Bronwen Connolly, BSc (Hons), MSc    +44 203 299 9000 ext 2080    bronwen.connolly@nhs.net   
Principal Investigator: Bronwen Connolly, BSc (Hons), MSc         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Study Director: Nicholas Hart, BSc (Hons), MBBS, MRCP, PhD St.Thomas' Hospital
  More Information

No publications provided

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
Study First Received: September 11, 2009
Last Updated: November 22, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by 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

ClinicalTrials.gov processed this record on July 22, 2014