Outpatient Based Physical Rehabilitation for Survivors of Prolonged Critical Illness

NCT02491021 | Completed Phase 2

• 1 other identifier: 06/Q1402/39
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rehabilitation After Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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).

  At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later

Secondary Outcomes (1)

• Short Form 36 Health Questionnaire

  At recruitment (within 6 weeks of hospital discharge) and then reassessed 8-10 weeks later

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

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.

Other: Rehabilitation Class

Control Group

NO INTERVENTION

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.

Interventions

Rehabilitation Class OTHER

A 6 week programme of exercise and education in an out patient setting

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over the age of 18
• admitted to a single, tertiary centre United Kingdom general intensive care unit (ICU)
• Invasively ventilated ≥ 5 days

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr David McWilliams

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 7, 2015
• Study Start: October 1, 2007
• Primary Completion: December 1, 2011
• Last Updated: July 8, 2015

Record last verified: 2015-07