Clinical trial NCT04175717: Feasibility of a Physiotherapy-led Follow-up Programme in Adult Critical Illness Survivors
Official title: Is a Physiotherapy-led Follow-up Programme Feasible in Adult Critical Illness Survivors After Discharge Home: A Single-center Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post Intensive Care Unit Syndrome
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Survivors of critical illness might suffer from ongoing physical, cognitive and emotional impairments after being discharged home. Furthermore, several studies have shown that these patients might have a need for ongoing support. However, up until now, it is not known what the optimal follow-up programme for survivor of critical illness after discharge home should look like or which exact patient population would benefit the most. Due to these reasons, it is important to further investigate, how these patients can be optimally supported to recover from their critical illness.

The primary aim of this study is to assess, whether a physiotherapy-led follow-up programme is feasible in adult survivors of critical illness after discharge home in the county hospital of Winterthur.

Furthermore, the investigators evaluate the influence of this physiotherapy-led follow-up programme on health related quality of life, exercise capacity, general muscle strength, inspiratory muscle strength, anxiety and depression.

All of the anticipated 20 patients will partake in the follow-up programme, which will consist out of a nine weeks exercise programme and four education sessions. During the exercise programme, the patients will exercise twice per week under supervision and once by themselves. The supervised exercise sessions will consist out of a combination of a cardiopulmonary and strength training and the unsupervised session will be a physical activity, which the participants like doing. Furthermore, they will participate in education sessions, where they learn things about the intensive care unit, the post-intensive care syndrome, relaxation techniques and how to carry on with exercising.

The whole study will last about ten months and forms a part of a master thesis.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent after being informed
* Adult patient (\>18 years), who was treated in the ICU of the county hospital of Winterthur and who was ventilated for longer than 48 hours
* Patient, who received inpatient rehabilitation and then was discharged home

Exclusion Criteria:

* Head or spinal cord injury, leading to neurological deficits
* Receiving palliative care
* Fractures diminishing mobility
* Principal diagnosis of chronic obstructive pulmonary disease (COPD)
* Principal diagnosis of myocardial infarction, heart failure or reanimation
* Principal diagnosis of stroke or cerebral bleeding
* Previous diagnosis of dementia or cognitive impairment
* Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc.;
* Enrolment of the investigator, his/her family members, employees and other dependent persons

Primary outcomes:
measure: The number of participants, who have completed the nine weeks physiotherapy-led follow-up programme
timeFrame: 10 weeks
Secondary outcomes:
measure: Health related quality of life
timeFrame: 10 weeks
measure: Exercise capacity
timeFrame: 10 weeks
measure: General muscle strength
timeFrame: 10 weeks
measure: Inspiratory muscle strength
timeFrame: 10 weeks
measure: Anxiety and Depression
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zürich
Study officials:
affiliation: Institut für Therapien und Rehabilitation, Kantonsspital Winterthur
name: Ott Natalie
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
citation: Cuthbertson BH, Roughton S, Jenkinson D, Maclennan G, Vale L. Quality of life in the five years after intensive care: a cohort study. Crit Care. 2010;14(1):R6. doi: 10.1186/cc8848. Epub 2010 Jan 20.
citation: Davydow DS, Gifford JM, Desai SV, Bienvenu OJ, Needham DM. Depression in general intensive care unit survivors: a systematic review. Intensive Care Med. 2009 May;35(5):796-809. doi: 10.1007/s00134-009-1396-5. Epub 2009 Jan 23.
citation: Desai SV, Law TJ, Needham DM. Long-term complications of critical care. Crit Care Med. 2011 Feb;39(2):371-9. doi: 10.1097/CCM.0b013e3181fd66e5.
citation: King J, O'Neill B, Ramsay P, Linden MA, Darweish Medniuk A, Outtrim J, Blackwood B. Identifying patients' support needs following critical illness: a scoping review of the qualitative literature. Crit Care. 2019 May 24;23(1):187. doi: 10.1186/s13054-019-2441-6.
citation: Prinjha S, Field K, Rowan K. What patients think about ICU follow-up services: a qualitative study. Crit Care. 2009;13(2):R46. doi: 10.1186/cc7769. Epub 2009 Apr 1.
citation: Taito S, Yamauchi K, Tsujimoto Y, Banno M, Tsujimoto H, Kataoka Y. Does enhanced physical rehabilitation following intensive care unit discharge improve outcomes in patients who received mechanical ventilation? A systematic review and meta-analysis. BMJ Open. 2019 Jun 9;9(6):e026075. doi: 10.1136/bmjopen-2018-026075.