Critical IllnessNCT05349994
Extended Physiotherapy After Intensive Care Unit (ICU) Stay
A study testing Extended physiotherapy in people with Critical Illness and Physical Disability, run by Stockholm South General Hospital at 1 site in Sweden.
Trial summary
Patients in an Intensive Care Unit (ICU) are at great risk of muscle atrophy and neuromuscular complications, that could lead to respiratory complications, decreased physical functioning and deteriorated health related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Physical Disability
- What is being tested?
- Extended physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- 29 Jan 2019to 24 Dec 2019
- 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
- Age over 18 years
- ICU stay >48 hours
- Understand the Swedish language
Who cannot join
- Patients palliative care with no intention of rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended Physiotherapy After Intensive Care Unit (ICU) Stay: A Prospective Before and After Study
Patients in an Intensive Care Unit (ICU) are at great risk of muscle atrophy and neuromuscular complications, that could lead to respiratory complications, decreased physical functioning and deteriorated health related quality of life. The objective is to investigate if extended physical therapy in a general ward could lead to increased physical functioning for post-ICU patients.The study hypothesis is that extended physical therapy would lead to increased physical function at hospital discharge compared to standard amount of physical therapy.
Read the detailed description
The study design is a before and after study. A control group was included for three months and received standard amount of physical therapy at surgical wards, corresponding to 1.75 employment. An intervention group was then included for six months and received extended amount of physical therapy corresponding to an extra 0.5 employment for study participants (2-4 patients/day). The primary outcome was physical function measured with the Chelsea Critical Care Physical Assessment Tool (CPAx), in the ICU and the surgical ward.
- Conditions
- Critical Illness, Physical Disability
- Being tested
- Extended physiotherapy
- Keywords
- Physical therapy, Physical function
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended physiotherapyOther
At admission to the surgical ward after ICU care, participants received an individual rehabilitation plan developed in collaboration with the participants and the ward-based physiotherapist. The rehabilitation plan included specified exercises for 1- 2 sessions of approximately 30 minutes a day. For example breathing exercises, practicing transfer in and out of bed and from sitting to standing, stairclimbing, and walking with or without walking aids.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard amount of physical therapy at surgical wards in an urban hospital, corresponding to 1.75 physiotherapy employment on weekdays divided on four wards with a total of approx. 40-48 patients. |
| Intervention | Experimental | Extended physiotherapy with an extra 0.5 employment on weekdays, leading to 1-2 physiotherapy session per day for the study participants in the intervention group. Receives: Other: Extended physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in physical function according to Chelsea Critical Care Physical Assessment tool (CPAx)
Measures physical function in critically ill patients
Measured: Through study completion, an average of 2 weeks per participant
Secondary outcomes (3)
Feasibility of intervention
Number of planned interventions not delivered, and number of safety events.
Measured: Through study completion, an average of 2 weeks per participant
Length of stay at the ward
Number of days at the hospital ward after ICU discharge
Measured: Through study completion, an average of 2 weeks per participant
Readmission to ICU
Number of readmissions to ICU from ward, within each study group
Measured: Through study completion, an average of 2 weeks per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start29 Jan 2019
- Primary completion24 Dec 2019
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study design was a before and after study. A control group was included for three months and received standard care. An intervention group was then included for six months and received extended amount of physical therapy.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm South General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katinka Siesage, Stockholm South General Hospital
- Investigators
- Katinka Siesage, Principal investigator, Stockholm South General HospitalEva Alm- Joelsson, Principal investigator, Stockholm South General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349994
- Sponsor's protocol ID
- Improvement project AFE
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available on request due to privacy/ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Physiotherapy After Intensive Care Unit (ICU) Stay: A Prospective Before and After Study
- ClinicalTrials.gov ID
- NCT05349994
- Acronym / sponsor ID
- Improvement project AFE
- Conditions
- Critical Illness, Physical Disability
- Keywords
- Physical therapy, Physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Stockholm South General HospitalUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients in an Intensive Care Unit (ICU) are at great risk of muscle atrophy and neuromuscular complications, that could lead to respiratory complications, decreased physical functioning and deteriorated health related quality of life. The objective is to investigate if extended physical therapy in a general ward could lead to increased physical functioning for post-ICU patients.The study hypothesis is that extended physical therapy would lead to increased physical function at hospital discharge compared to standard amount of physical therapy.
Detailed description
The study design is a before and after study. A control group was included for three months and received standard amount of physical therapy at surgical wards, corresponding to 1.75 employment. An intervention group was then included for six months and received extended amount of physical therapy corresponding to an extra 0.5 employment for study participants (2-4 patients/day). The primary outcome was physical function measured with the Chelsea Critical Care Physical Assessment Tool (CPAx), in the ICU and the surgical ward.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design was a before and after study. A control group was included for three months and received standard care. An intervention group was then included for six months and received extended amount of physical therapy.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard amount of physical therapy at surgical wards in an urban hospital, corresponding to 1.75 physiotherapy employment on weekdays divided on four wards with a total of approx. 40-48 patients. |
| Intervention | Experimental | Other: Extended physiotherapyExtended physiotherapy with an extra 0.5 employment on weekdays, leading to 1-2 physiotherapy session per day for the study participants in the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years
- ICU stay >48 hours
- Understand the Swedish language
Key exclusion criteria (1 listed)
- Patients palliative care with no intention of rehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended physiotherapyAt admission to the surgical ward after ICU care, participants received an individual rehabilitation plan developed in collaboration with the participants and the ward-based physiotherapist. The rehabilitation plan included specified exercises for 1- 2 sessions of approximately 30 minutes a day. For example breathing exercises, practicing transfer in and out of bed and from sitting to standing, stairclimbing, and walking with or without walking aids. | Other | Intervention |
Primary outcome
Changes in physical function according to Chelsea Critical Care Physical Assessment tool (CPAx)
Time frame: Through study completion, an average of 2 weeks per participant
Measures physical function in critically ill patients
3 secondary outcomes
Feasibility of intervention
Time frame: Through study completion, an average of 2 weeks per participant
Length of stay at the ward
Time frame: Through study completion, an average of 2 weeks per participant
Readmission to ICU
Time frame: Through study completion, an average of 2 weeks per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No. Data available on request due to privacy/ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katinka Siesage principal investigator
Stockholm South General Hospital
Eva Alm- Joelsson principal investigator
Stockholm South General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended physiotherapy in people with Critical Illness and Physical Disability, run by Stockholm South General Hospital at 1 site in Sweden.
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 1 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: finished, as of the sponsor's last update on 27 Apr 2022. 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in physical function according to Chelsea Critical Care Physical Assessment tool (CPAx) (time frame: Through study completion, an average of 2 weeks per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2022.