Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001202954
Ethics application status
Approved
Date submitted
14/09/2020
Date registered
12/11/2020
Date last updated
25/01/2024
Date data sharing statement initially provided
12/11/2020
Date results provided
25/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the effect of passive movements on joint stiffness in intensive care unit patients?
Scientific title
Investigating the effect of passive movements on ankle dorsiflexion range of motion in intensive care unit patients
Secondary ID [1] 302295 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 319044 0
Reduced range of joint movement 319372 0
Condition category
Condition code
Musculoskeletal 316998 316998 0 0
Other muscular and skeletal disorders
Neurological 316999 316999 0 0
Other neurological disorders
Respiratory 317000 317000 0 0
Other respiratory disorders / diseases
Injuries and Accidents 317344 317344 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the purposes of this study, the intervention for the side of the body allocated to receive passive movements will involve the treating intensive care unit (ICU) physiotherapist moving the participant’s elbow and ankle joints through a full range of motion. These two joints were selected for the intervention based on previous research and our own anecdotal experience in ICU regarding which joints seem to get stiff most frequently, and the ease of measurement of range of motion.
The intensity, frequency and duration of the intervention, as follows, is based on a treatment protocol used in a previous published study and survey responses reported previously. We elected to use a relatively intensive passive movement regimen as we want to maximise the likelihood of finding a treatment effect. Passive movements will be given to the elbow and ankle joints on the allocated side for 10 minutes each in the morning and afternoon, five days per week (weekdays). It is anticipated that participants will require the intervention for at least a two week period, though there is no mandatory minimum intervention duration.
The intervention for the ankle joint will involve dorsiflexion (with knee in extension and flexion), plantarflexion, inversion and eversion through the available range of motion. For the elbow joint the intervention will involve flexion, extension, pronation and supination through the available range of motion. No force will be used at the end of joint range. As per usual clinical practice, no specific advice will be given to the treating physiotherapists regarding cadence of movements. Adherence with the provision of this intervention will be recorded on a purpose-designed form.
In keeping with usual clinical practice, the passive movements intervention (to the ankle and elbow on the allocated side of the body) will continue until the participant is able to actively and independently move their ankles and elbows (both sides) through a full range of motion. The time point at which this occurs will be recorded. If the treating physiotherapist believes the participant is able to actively and independently move their ankles and elbow through a full range of motion (and thus no longer requires the passive movements intervention), this decision will be assessed, at the request of the treating physiotherapist, by another blinded physiotherapist. This assessment will comprise: (1) conscious state, using the Glasgow Coma Scale (score greater or equal to 13; e.g. opens eyes to speech, confused, obeys commands); (2) muscle power at ankles and elbows (greater than or equal to 3 out of 5, manual muscle test); (3) visual assessment that participant can independently move his/her ankles and elbows through a full range of motion.
Other physiotherapy interventions (e.g. sitting out of bed, standing, walking) will continue as indicated, as per usual clinical practice, throughout the study period. If the participant is unable to actively and independently move their ankles and elbows through a full ROM by study completion (4 weeks), the clinical trial will still cease at this time point. If the participant is transferred out of ICU before study completion, the passive movements intervention will continue to be provided (if required) in the general ward and outcomes will be recorded as per the study protocol.
Control side
The side of the body allocated as the control side will not receive any passive movements by a physiotherapist as per standard practice our ICU.
Intervention code [1] 318578 0
Prevention
Intervention code [2] 318579 0
Rehabilitation
Comparator / control treatment
The side of the body allocated as the control side will not receive any passive movements by a physiotherapist as per standard practice within our ICU.
Control group
Active

Outcomes
Primary outcome [1] 325105 0
Passive ankle dorsiflexion range of motion. Measured using a standard goniometer.
Timepoint [1] 325105 0
Baseline, at cessation of passive movements (if required) and 4 weeks after commencement of intervention.
Secondary outcome [1] 386852 0
Passive ankle plantarflexion. Measured with a standard goniometer.
Timepoint [1] 386852 0
Baseline, at cessation of passive movements (if required) and 4 weeks after commencement of intervention.
Secondary outcome [2] 386853 0
Passive elbow flexion. Measured with a standard goniometer.
Timepoint [2] 386853 0
Baseline, at cessation of passive movements (if required) and 4 weeks after commencement of intervention.
Secondary outcome [3] 386854 0
Passive elbow extension. Measured with a standard goniometer.
Timepoint [3] 386854 0
Baseline, at cessation of passive movements (if required) and 4 weeks after commencement of intervention.
Secondary outcome [4] 386855 0
Self-reported pain/stiffness in ankles/elbows. Measured with a verbal analogue scale (0-10 where 0 = no pain/stiffness and 10 = worst pain/stiffness imaginable).
Timepoint [4] 386855 0
Baseline, at cessation of passive movements (if required) and 4 weeks after commencement of intervention.
Secondary outcome [5] 386856 0
Maximal mobility. Measured using the ICU Mobility Scale.
Timepoint [5] 386856 0
Baseline, at cessation of passive movements (if required) and 4 weeks after commencement of intervention.
Secondary outcome [6] 386857 0
Participant feedback on study interventions. Measured using a purpose-designed short questionnaire.
Timepoint [6] 386857 0
At cessation of passive movements or 4 weeks after commencement of intervention.

Eligibility
Key inclusion criteria
• Admitted to the Royal Adelaide Hospital ICU.
• Intubated and expected to remain invasively mechanically ventilated > 48 hours (total).
• Anticipated ICU length of stay greater than or equal to 5 days.
• Aged greater than or equal to 18 years.
• Unable to move their limbs through full range of motion voluntarily (either unconscious/sedated patients and/or those who are not able to move their limbs due to their underlying medical condition). This is likely to include patients with medical illnesses (e.g. severe respiratory failure, sepsis) who are receiving sedative medications as part of their care and/or patients after spinal cord injury or traumatic brain injury.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Refused consent (by patient or the person legally responsible or medical decision maker for that patient [if the patient is unable to consider participation due to their medical status]).
• Admitted with a burn injury.
• COVID-19 positive.
• Pre-existing condition/injury that has adversely affected joint range of motion (e.g. rheumatoid arthritis, neurological condition resulting in spasticity and contracture).
• Documented pre-existing inability to understand written or spoken English to the extent that it would prevent comprehension of the aims and methodology of the proposed study.
• Medical or surgical condition where the management includes no passive movements in a limb (e.g. limb fractures).
• Death is deemed inevitable as a result of the current illness.
• If the ICU admission is not the first ICU admission in the current hospitalisation.
• Currently enrolled in another ICU interventional rehabilitation study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following consent, each participant will have one side of their body randomly allocated to receive the intervention (passive movements) and the other side to act as a control. Each participant’s side-of-body allocation will be placed in a sealed, sequentially numbered envelope to ensure concealment. These envelopes will only be opened after the participant has completed all pre-intervention assessments and will be stored off site at the house of one of the investigators who will be contacted by phone to reveal the side-of-body allocation. Commencement of the intervention will be on the day of randomisation and will conclude at four weeks. Due to the nature of the intervention it will not be possible to blind the physiotherapists providing the treatment interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation table will be created by an independent statistician to determine the allocation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The study design is a randomised, controlled, within-participant, assessor-blinded study. One side of the participant's body will be allocated to the intervention group (passive movements) and the other side of the body to the control group (no passive movements).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation for this study was undertaken by an independent statistician. This calculation was based on the primary outcome (ankle dorsiflexion range of motion) data reported in a previous study using a paired t test for the mean difference. Using 80% power to detect a treatment effect of five degrees, assuming a standard deviation of 9.5 degrees, correlation of 0.6, alpha of 0.05 and a two-sided test, resulted in a sample size of 25 participants. Thus, a sample size of at least 25 participants will be sought, with recruitment continuing until we have 25 completed sets of data.
Statistical analyses will be undertaken by an independent statistician, primarily using liner mixed-effect models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2021
Actual
17/02/2021
Date of last participant enrolment
Anticipated
Actual
25/01/2023
Date of last data collection
Anticipated
Actual
22/02/2023
Sample size
Target
25
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17520 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 31250 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 306720 0
Hospital
Name [1] 306720 0
Royal Adelaide Hospital
Country [1] 306720 0
Australia
Primary sponsor type
Individual
Name
Kathy Stiller
Address
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 307268 0
Individual
Name [1] 307268 0
Simone Dafoe
Address [1] 307268 0
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country [1] 307268 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306890 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306890 0
Ethics committee country [1] 306890 0
Australia
Date submitted for ethics approval [1] 306890 0
02/07/2020
Approval date [1] 306890 0
22/10/2020
Ethics approval number [1] 306890 0
CALHN reference 13731

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105362 0
Dr Kathy Stiller
Address 105362 0
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country 105362 0
Australia
Phone 105362 0
+61 8 70742639
Fax 105362 0
Email 105362 0
[email protected]
Contact person for public queries
Name 105363 0
Kathy Stiller
Address 105363 0
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country 105363 0
Australia
Phone 105363 0
+61 8 70742639
Fax 105363 0
Email 105363 0
[email protected]
Contact person for scientific queries
Name 105364 0
Kathy Stiller
Address 105364 0
Royal Adelaide Hospital
Port Road
Adelaide
SA 5000
Country 105364 0
Australia
Phone 105364 0
+61 8 70742639
Fax 105364 0
Email 105364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.