Feasibility of a Physiotherapy-led Follow-up Programme in Adult Critical Illness Survivors

NCT04175717 | Terminated

• 1 other identifier: PT-follow-up-post-ICU
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (1)

• The number of participants, who have completed the nine weeks physiotherapy-led follow-up programme

  As part of the feasibility assessment of this physiotherapy-led follow-up programme in the county hospital of Winterthur, it will be assessed, how many participants are able to complete the whole programme.

  10 weeks

Secondary Outcomes (5)

• Health related quality of life

  10 weeks

• Exercise capacity

  10 weeks

• General muscle strength

  10 weeks

• Inspiratory muscle strength

  10 weeks

• Anxiety and Depression

  10 weeks

Study Arms (1)

physiotherapy-led follow-up programme

EXPERIMENTAL

Other: physiotherapy-led follow-up programme

Interventions

physiotherapy-led follow-up programme OTHER

In this study arm, the participants will receive 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 consisted out of a combination of a cardiopulmonary and strength training and the unsupervised session will be an activity, which the participants like doing. Additionally, when the patient shows a reduced maximal inspiratory pressure (indication for a reduced diaphragm strength), the patient will also be ask to do an inspiratory muscle training at home. 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.

physiotherapy-led follow-up programme

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 21470008 BACKGROUND

• 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.

  PMID: 20089197 BACKGROUND

• 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.

  PMID: 19165464 BACKGROUND

• 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.

  PMID: 20959786 BACKGROUND

• 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.

  PMID: 31126335 BACKGROUND

• 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.

  PMID: 19338653 BACKGROUND

• 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.

  PMID: 31182443 BACKGROUND

Study Officials

• Ott Natalie

  Institut für Therapien und Rehabilitation, Kantonsspital Winterthur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical specialist in intensive care physiotherapy

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 25, 2019
• Study Start: January 20, 2020
• Primary Completion: March 19, 2020
• Study Completion: May 7, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)