search
Back to results

Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness

Primary Purpose

Rehabilitation After Critical Illness

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rehabilitation Class
Sponsored by
University Hospital Birmingham NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rehabilitation After Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All patients over the age of 18

  • admitted to a single, tertiary centre United Kingdom general intensive care unit (ICU)
  • Invasively ventilated ≥ 5 days

Exclusion Criteria:

  • Physical condition resulting in an inability to perform a cardio-pulmonary exercise test (CPET) or to participate in the rehabilitation classes,
  • Psychiatric condition or impairment not allowing informed consent or compliance with the rehabilitation programme,
  • Participation in an alternative rehabilitation programme,
  • Terminal illness
  • Poorly controlled cardio-respiratory disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Treatment Group

    Control Group

    Arm Description

    Treatment Group (TG) The TG underwent a 7-week outpatient rehabilitation programme comprising both exercise and education sessions under the direct supervision of the physiotherapy team. The exercise intervention was 20 minutes, 3x/week (1 supervised, 2 self directed) titrated to a specific intensity based on risk stratification - highvs low risk). The intervention also included 6 x 1 hour education sessions.

    Control Group (CG) The CG received physiotherapy, exercises and education as per current standards of practice in our institution up until hospital discharge. Following discharge no further specific input or education was provided. Participants were contacted at least once during the study period to check on their general well being and to encourage attendance at the second assessment by the physiotherapy team. In line with the ethical requirements for the study, all control subjects were offered the chance to participate in the rehabilitation programme once their trial participation was completed following second assessment.

    Outcomes

    Primary Outcome Measures

    Cardiopulmonary Exercise Testing
    Primary outcome was the change in exercise capacity measured by changes in peak VO2 and anaerobic threshold (AT) assessed using cardio-pulmonary exercise testing (CPET).

    Secondary Outcome Measures

    Short Form 36 Health Questionnaire
    Secondary outcome measures were changes in health related Quality of life (QoL). assessed using the Medical Outcome Study Short Form-36 questionnaire Version 2 (SF36v2). Subjects were asked to answer questions based on a 2-week recall period.

    Full Information

    First Posted
    July 2, 2015
    Last Updated
    July 7, 2015
    Sponsor
    University Hospital Birmingham NHS Foundation Trust
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02491021
    Brief Title
    Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness
    Official Title
    Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness - a Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    December 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital Birmingham NHS Foundation Trust

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Admission to an intensive care unit (ICU) due to illness has been shown to have a dramatic effect on the human body and mind. Following discharge from an ICU, patients suffer from varying degrees of weakness and muscle wasting. It can take many months before their strength returns to something like before they were ill. This weakness can have important consequences on an individual, affecting their ability to perform routine tasks (e.g. housework, shopping), and whether they can return to work or not. Not surprisingly, this inability to perform activities they used to do prior to their illness can have knock on effects on their mental well being and confidence. What the investigators hope to see through this study is whether or not patients can recover their ability to perform exercise more quickly following an ICU admission if they undergo an exercise-based rehabilitation programme. The investigators also hope to see whether taking part in a rehabilitation programme has any affect on physical and mental well being. The investigators hope to use a simple exercise test on a bicycle to assess subjects ability to exercise shortly after leaving hospital. We will then repeat the test after a period of physiotherapy lead rehabilitation to see if they have received any benefit from the programme. The investigators hope to show that by undergoing an exercise-based rehabilitation programme subjects will recover their ability to exercise more quickly than those who do not. By means of questionnaires the investigators hope to see what effect the rehabilitation programme has had on participants physical and mental well being.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rehabilitation After Critical Illness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Active Comparator
    Arm Description
    Treatment Group (TG) The TG underwent a 7-week outpatient rehabilitation programme comprising both exercise and education sessions under the direct supervision of the physiotherapy team. The exercise intervention was 20 minutes, 3x/week (1 supervised, 2 self directed) titrated to a specific intensity based on risk stratification - highvs low risk). The intervention also included 6 x 1 hour education sessions.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Control Group (CG) The CG received physiotherapy, exercises and education as per current standards of practice in our institution up until hospital discharge. Following discharge no further specific input or education was provided. Participants were contacted at least once during the study period to check on their general well being and to encourage attendance at the second assessment by the physiotherapy team. In line with the ethical requirements for the study, all control subjects were offered the chance to participate in the rehabilitation programme once their trial participation was completed following second assessment.
    Intervention Type
    Other
    Intervention Name(s)
    Rehabilitation Class
    Intervention Description
    A 6 week programme of exercise and education in an out patient setting
    Primary Outcome Measure Information:
    Title
    Cardiopulmonary Exercise Testing
    Description
    Primary outcome was the change in exercise capacity measured by changes in peak VO2 and anaerobic threshold (AT) assessed using cardio-pulmonary exercise testing (CPET).
    Time Frame
    At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later
    Secondary Outcome Measure Information:
    Title
    Short Form 36 Health Questionnaire
    Description
    Secondary outcome measures were changes in health related Quality of life (QoL). assessed using the Medical Outcome Study Short Form-36 questionnaire Version 2 (SF36v2). Subjects were asked to answer questions based on a 2-week recall period.
    Time Frame
    At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients over the age of 18 admitted to a single, tertiary centre United Kingdom general intensive care unit (ICU) Invasively ventilated ≥ 5 days Exclusion Criteria: Physical condition resulting in an inability to perform a cardio-pulmonary exercise test (CPET) or to participate in the rehabilitation classes, Psychiatric condition or impairment not allowing informed consent or compliance with the rehabilitation programme, Participation in an alternative rehabilitation programme, Terminal illness Poorly controlled cardio-respiratory disease

    12. IPD Sharing Statement

    Learn more about this trial

    Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness

    We'll reach out to this number within 24 hrs