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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04175717
Recruitment Status : Terminated (Due to COVID pandemic)
First Posted : November 25, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Natalie Ott, Kantonsspital Winterthur KSW

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.


Condition or disease Intervention/treatment Phase
Post Intensive Care Unit Syndrome Other: physiotherapy-led follow-up programme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is a Physiotherapy-led Follow-up Programme Feasible in Adult Critical Illness Survivors After Discharge Home: A Single-center Trial
Actual Study Start Date : January 20, 2020
Actual Primary Completion Date : March 19, 2020
Actual Study Completion Date : May 7, 2020

Arm Intervention/treatment
Experimental: physiotherapy-led follow-up programme Other: 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.




Primary Outcome Measures :
  1. The number of participants, who have completed the nine weeks physiotherapy-led follow-up programme [ Time Frame: 10 weeks ]
    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 :
  1. Health related quality of life [ Time Frame: 10 weeks ]
    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).

  2. Exercise capacity [ Time Frame: 10 weeks ]
    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.

  3. General muscle strength [ Time Frame: 10 weeks ]
    General muscle strength will be measured by the hand grip test with a Jamar dynamometer. The results will be reported in kilograms.

  4. Inspiratory muscle strength [ Time Frame: 10 weeks ]
    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.

  5. Anxiety and Depression [ Time Frame: 10 weeks ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175717


Locations
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Switzerland
Kantonsspital Winterthur
Winterthur, Zürich, Switzerland, 8401
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
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Principal Investigator: Ott Natalie Institut für Therapien und Rehabilitation, Kantonsspital Winterthur
Publications:

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Responsible Party: Natalie Ott, Clinical specialist in intensive care physiotherapy, Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT04175717    
Other Study ID Numbers: PT-follow-up-post-ICU
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes