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

Primary Purpose

Post Intensive Care Unit Syndrome

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
physiotherapy-led follow-up programme
Sponsored by
Kantonsspital Winterthur KSW
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Intensive Care Unit Syndrome

Eligibility Criteria

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

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

Sites / Locations

  • Kantonsspital Winterthur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

physiotherapy-led follow-up programme

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Health related quality of life
Health related quality of life will be measured by the EQ-5D L5 self-complete paper version, which is a self-report questionnaire. Th questionnaire contains five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), with each five levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The participants rate themselves in these levels. Additionally, they are also asked to rate their health on a visual analog scale from 0 (worst health you can imagine) to 100 (best health you could imagine).
Exercise capacity
Exercise capacity will be evaluated by the six minute walking test, which is a self-paced walking test to assess submaximal functional exercise capacity. The result will tell us, how many meters the participant could walk in six minutes.
General muscle strength
General muscle strength will be measured by the hand grip test with a Jamar dynamometer. The results will be reported in kilograms.
Inspiratory muscle strength
Inspiratory muscle strength will be evaluated by the CareFusion micro RPM, which measures the maximal inspiratory pressure at the level of the mouth. The results will be reported in centimeter of water.
Anxiety and Depression
Levels of anxiety and depression will be assessed by the hospital anxiety and depression scale (HADS), which is a self-administered questionnaire. It contains 14 items (seven to assess anxiety levels und seven to assess depression levels). Each item can be scored from zero to three, leading to a maximal score of 21. The higher a participants scores, the more likely he is to suffer from anxiety or depression (or both).

Full Information

First Posted
November 7, 2019
Last Updated
September 2, 2020
Sponsor
Kantonsspital Winterthur KSW
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1. Study Identification

Unique Protocol Identification Number
NCT04175717
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID pandemic
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Winterthur KSW

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Intensive Care Unit Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physiotherapy-led follow-up programme
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
physiotherapy-led follow-up programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of participants, who have completed the nine weeks physiotherapy-led follow-up programme
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
Health related quality of life will be measured by the EQ-5D L5 self-complete paper version, which is a self-report questionnaire. Th questionnaire contains five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), with each five levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The participants rate themselves in these levels. Additionally, they are also asked to rate their health on a visual analog scale from 0 (worst health you can imagine) to 100 (best health you could imagine).
Time Frame
10 weeks
Title
Exercise capacity
Description
Exercise capacity will be evaluated by the six minute walking test, which is a self-paced walking test to assess submaximal functional exercise capacity. The result will tell us, how many meters the participant could walk in six minutes.
Time Frame
10 weeks
Title
General muscle strength
Description
General muscle strength will be measured by the hand grip test with a Jamar dynamometer. The results will be reported in kilograms.
Time Frame
10 weeks
Title
Inspiratory muscle strength
Description
Inspiratory muscle strength will be evaluated by the CareFusion micro RPM, which measures the maximal inspiratory pressure at the level of the mouth. The results will be reported in centimeter of water.
Time Frame
10 weeks
Title
Anxiety and Depression
Description
Levels of anxiety and depression will be assessed by the hospital anxiety and depression scale (HADS), which is a self-administered questionnaire. It contains 14 items (seven to assess anxiety levels und seven to assess depression levels). Each item can be scored from zero to three, leading to a maximal score of 21. The higher a participants scores, the more likely he is to suffer from anxiety or depression (or both).
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ott Natalie
Organizational Affiliation
Institut für Therapien und Rehabilitation, Kantonsspital Winterthur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Winterthur
City
Winterthur
State/Province
Zürich
ZIP/Postal Code
8401
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21470008
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.
Results Reference
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PubMed Identifier
20089197
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.
Results Reference
background
PubMed Identifier
19165464
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.
Results Reference
background
PubMed Identifier
20959786
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.
Results Reference
background
PubMed Identifier
31126335
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.
Results Reference
background
PubMed Identifier
19338653
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.
Results Reference
background
PubMed Identifier
31182443
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.
Results Reference
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Feasibility of a Physiotherapy-led Follow-up Programme in Adult Critical Illness Survivors

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