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Post Intensive Care Unit SyndromeNCT04175717

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

A study testing physiotherapy-led follow-up programme in people with Post Intensive Care Unit Syndrome, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Intensive Care Unit Syndrome
What is being tested?
physiotherapy-led follow-up programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteSwitzerland
Study dates
20 Jan 2020to 7 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Kantonsspital Winterthur

    Winterthur, Canton of Zurich, 8401

Other trials in Switzerland

About this study

Official title: Is a Physiotherapy-led Follow-up Programme Feasible in Adult Critical Illness Survivors After Discharge Home: A Single-center Trial

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.

Read more

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.

Being tested
physiotherapy-led follow-up programme

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • physiotherapy-led follow-up programmeOther

    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.

Study groups in NCT04175717
Study groupRoleWhat they receive
physiotherapy-led follow-up programmeExperimentalNot described
Receives: Other: physiotherapy-led follow-up programme

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 weeks

Secondary outcomes (5)

  1. 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).

    Measured: 10 weeks

  2. 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.

    Measured: 10 weeks

  3. 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.

    Measured: 10 weeks

  4. 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.

    Measured: 10 weeks

  5. 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).

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2019
  2. Study start20 Jan 2020
  3. Primary completion19 Mar 2020
  4. Study completion7 May 2020

Why it stopped: Due to COVID pandemic

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04175717
Sponsor's protocol ID
PT-follow-up-post-ICU
Status last verified
Sep 2020
First submitted
7 Nov 2019
Last updated
4 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21470008

  • 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.

    PubMed 20089197

  • 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.

    PubMed 19165464

  • 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.

    PubMed 20959786

  • 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.

    PubMed 31126335

  • 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.

    PubMed 19338653

  • 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.

    PubMed 31182443

Questions about this trial

What is this clinical trial studying?

A study testing physiotherapy-led follow-up programme in people with Post Intensive Care Unit Syndrome, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to COVID pandemic). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of participants, who have completed the nine weeks physiotherapy-led follow-up programme (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04175717, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.

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