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

NCT ID: NCT04175717

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2020-05-07

Brief Summary

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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.

Detailed Description

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Conditions

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Post Intensive Care Unit Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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physiotherapy-led follow-up programme

Group Type EXPERIMENTAL

physiotherapy-led follow-up programme

Intervention Type 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.

Interventions

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physiotherapy-led follow-up programme

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Winterthur KSW

OTHER

Sponsor Role lead

Responsible Party

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Natalie Ott

Clinical specialist in intensive care physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ott Natalie

Role: PRINCIPAL_INVESTIGATOR

Institut für Therapien und Rehabilitation, Kantonsspital Winterthur

Locations

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Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 21470008 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20089197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19165464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20959786 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31126335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19338653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31182443 (View on PubMed)

Other Identifiers

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PT-follow-up-post-ICU

Identifier Type: -

Identifier Source: org_study_id

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